Renewal of the Network of Hubs for Trials Methodology Research.
Lead Research Organisation:
University College London
Department Name: MRC Clinical Trials Unit
Abstract
With the rising demands on the resources available for health care, it is increasingly important that decision makers, including practitioners, patients, policy makers and the public, have access to reliable and robust information about the relative effects of different interventions they might choose between. This information primarily comes from clinical trials which compared the interventions, and trials themselves need to be conducted in ways that are efficient and effective. In 2009, the MRC established the Hubs for Trials Methodology Research to conduct research to achieve this, and to facilitate the implementation of the findings of this research into practice in trials. A Network was created to add value to the work of the individual Hubs and this proposal seeks to renew the work of the Network for five more years and to extend the work to include a programme of training that will build capacity in methodology research for the future. This will be achieved by a unique programme of PhD studentships in trial methodology, which will create new experts in this area.
The Hubs provide a UK-wide, regionally distributed research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials. The Network links the Hubs to enhance their individual activities, strengthen the methodological research further, and improve dissemination and education relating to good methods in clinical trials. The Network provides funds for high priority research to answer specific issues around trials; conducts workshops to develop methods and train people involved in trials; organises a large international conference every two years to bring researchers together to share their current research and learn from each other; and, will establish and implement a new programme for PhD students to train as methodologists within a national programme of methodology research.
The Network helps the Hubs to work with many people and organisations who are key to clinical trials in the UK and internationally. These include those who fund trials, such as the National Institute for Health Research and major charities including Cancer Research UK, Arthritis UK and the British Heart Foundation; those who organise trials, including the pharmaceutical industry and universities; the groups that support them, including the UK-registered Clinical Trials Units, Research Design Services and Contract Research Organisations in the private sector; as well as the users of health care and individuals who run trials in academia, practice and industry.
Under this proposal, the Network will continue with its four main objectives and add a fifth relating to the PhD studentships. These objectives are:
a) Promoting high quality collaborative methodological research, both across Hubs and with other groups, UK-wide and internationally.
b) Providing methodological advice to the clinical trials community.
c) Encouraging the implementation of the most effective and appropriate methodological practice, for example by providing a coordinated package of education and training.
d) Working with external stakeholders, in particular to agree on shared priorities for research and guidance.
e) Capacity building of training in the UK by supporting a cohort of clinical and non-clinical PhD students in methodology.
The coordination of this studentship programme by the Network will:
> Create a cadre of scientists, including clinicians, with skills that will place them at the forefront of trials methodology development.
> Align the PhD studentships with the Network's strategic aims and research priorities, while reflecting the priorities of the Hub in which the student is based.
> Offer students unique inter-disciplinary and diverse analytical and technical skill training.
> Develop and sustain a vibrant postgraduate student culture in the Network.
> Raise the profile of the studentship programme, to attract outstanding candidates.
The Hubs provide a UK-wide, regionally distributed research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials. The Network links the Hubs to enhance their individual activities, strengthen the methodological research further, and improve dissemination and education relating to good methods in clinical trials. The Network provides funds for high priority research to answer specific issues around trials; conducts workshops to develop methods and train people involved in trials; organises a large international conference every two years to bring researchers together to share their current research and learn from each other; and, will establish and implement a new programme for PhD students to train as methodologists within a national programme of methodology research.
The Network helps the Hubs to work with many people and organisations who are key to clinical trials in the UK and internationally. These include those who fund trials, such as the National Institute for Health Research and major charities including Cancer Research UK, Arthritis UK and the British Heart Foundation; those who organise trials, including the pharmaceutical industry and universities; the groups that support them, including the UK-registered Clinical Trials Units, Research Design Services and Contract Research Organisations in the private sector; as well as the users of health care and individuals who run trials in academia, practice and industry.
Under this proposal, the Network will continue with its four main objectives and add a fifth relating to the PhD studentships. These objectives are:
a) Promoting high quality collaborative methodological research, both across Hubs and with other groups, UK-wide and internationally.
b) Providing methodological advice to the clinical trials community.
c) Encouraging the implementation of the most effective and appropriate methodological practice, for example by providing a coordinated package of education and training.
d) Working with external stakeholders, in particular to agree on shared priorities for research and guidance.
e) Capacity building of training in the UK by supporting a cohort of clinical and non-clinical PhD students in methodology.
The coordination of this studentship programme by the Network will:
> Create a cadre of scientists, including clinicians, with skills that will place them at the forefront of trials methodology development.
> Align the PhD studentships with the Network's strategic aims and research priorities, while reflecting the priorities of the Hub in which the student is based.
> Offer students unique inter-disciplinary and diverse analytical and technical skill training.
> Develop and sustain a vibrant postgraduate student culture in the Network.
> Raise the profile of the studentship programme, to attract outstanding candidates.
Technical Summary
The Network has added value to the Hubs for Trials Methodology Research by coordinating activities, encouraging and facilitating high-priority research projects, and facilitating the implementation of good practice into clinical trials in the UK and internationally. The Network facilitates the conduct and implementation of research into the design, conduct, analysis, interpretation, and reporting of clinical trials through cross-Hub work, as well as work between the Hubs and external teams. The Hubs and the Working Groups serve as key elements in delivering the strategy. The Network's objectives for the next period will be:
a) Promoting high quality collaborative methodological research, both across Hubs and with other groups, UK-wide and internationally
b) Providing methodological advice to the clinical trials community
c) Encouraging the implementation of the most effective and appropriate methodological practice, for example by providing a coordinated package of education and training
d) Working with external stakeholders, in particular to agree on shared priorities for research and guidance
e) Capacity building of training in the UK by supporting a cohort of clinical and non-clinical PhD students in methodology.
The work encompasses research into various aspects of clinical trial methods, including adaptive designs, statistical analysis, selection of outcomes and reporting of data. The Network resources are managed by the MRC CTU in London, with the Hub Directors as key drivers of the science, along with the convenors of six Working Groups, supported by the Network Co-ordinator.
There are close links to the UK-registered Clinical Trials Units, charities and research funders, and policy makers. The Network will strengthen its relationships with industry and build on existing relationships with clinicians through, for example, the Royal Colleges and with patients and the public through, for example, INVOLVE and the James Lind Alliance.
a) Promoting high quality collaborative methodological research, both across Hubs and with other groups, UK-wide and internationally
b) Providing methodological advice to the clinical trials community
c) Encouraging the implementation of the most effective and appropriate methodological practice, for example by providing a coordinated package of education and training
d) Working with external stakeholders, in particular to agree on shared priorities for research and guidance
e) Capacity building of training in the UK by supporting a cohort of clinical and non-clinical PhD students in methodology.
The work encompasses research into various aspects of clinical trial methods, including adaptive designs, statistical analysis, selection of outcomes and reporting of data. The Network resources are managed by the MRC CTU in London, with the Hub Directors as key drivers of the science, along with the convenors of six Working Groups, supported by the Network Co-ordinator.
There are close links to the UK-registered Clinical Trials Units, charities and research funders, and policy makers. The Network will strengthen its relationships with industry and build on existing relationships with clinicians through, for example, the Royal Colleges and with patients and the public through, for example, INVOLVE and the James Lind Alliance.
Planned Impact
Who will benefit from this research?
The Network will benefit the clinical trials community in the UK as a whole, including those working in academia, practice and industry. The research undertaken by the Network, the Hubs and the Working Groups addresses how clinical trials are conducted and provides a research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials. This is also likely to benefit trials outside the UK.
How will they benefit from this research?
We will continue to ensure engagement between stakeholders and the Network, in particular through our Working Groups. This will ensure that high priority issues are tackled and that stakeholders benefit from the collective knowledge of the Network.
Our regular meetings with the Directors of the CTUs will continue and partnerships will be extended through the Working Groups and the conduct of Network funded projects in areas identified as high priority by the CTUs.
Our main impact outside of academia is likely to be through stronger engagement with the other major source of clinical trials in the UK, namely the pharmaceutical industry. We will continue to work with the Association of British Pharmaceutical Industries, through engaging with the Experimental medicines expert network, and by attending appropriate meetings such as the R&D Conference in partnership with BIA and NOCRI. We will strengthen engagement with appropriate professional bodies (e.g. ensuring Network presence at meetings, including PSI conferences). We will provide opportunities for industry to present and participate in the Clinical Trials Methodology Conferences, ensuring their exposure to current methodological developments. We will work with Contract Research Organisations and software companies (such as Oracle Health Sciences Global Business Unit) who provide the infrastructure support for many industry trials. Further benefits will arise from the Network exploiting its capacity to act as a conduit between academia and industry, providing a link in the translational research pathway and ensuring that key issues are addressed via the Network Working Groups.
We will continue our engagement with charities, including the main funders of clinical trials in the UK: MRC, Health Technology Assessment Programme of the National Institute for Health Research, Cancer Research UK, Arthritis Research UK (ARUK), British Heart Foundation. This will build on previous collaborations, including, for example, joint funding for workshops between ARUK and the Network. Trial funders will also benefit from Network advice on the appropriate information to collect when funding is being requested for new trials, and during trials (such as in the 'go/no go' decision after a feasibility study).
The Network will continue to engage with regulatory bodies and similar agencies, including the Medicines and Health Regulatory Agency, National Institute for Health and Clinical Excellence, and the European Medicines Agency. This will ensure that the Network remains a key source of knowledge and influence in the development of new regulations.
The Network will strengthen its engagement with patient and public initiatives, including INVOLVE, which supports the involvement of the public in health and social care research. Individual Hubs have already worked with INVOLVE on issues relating to the involvement of patients in clinical trials. We will also work with the James Lind Alliance as it continues its efforts to identify shared priorities for research between patients and practitioners.
The Network will continue its work to promote good practice in clinical trials to a wide range of healthcare practitioners. This will include the provision of training in trials, publications and presentations aimed at practitioners rather than researchers, and further work to improve understanding and interpretation of the results of trials, including through systematic reviews.
The Network will benefit the clinical trials community in the UK as a whole, including those working in academia, practice and industry. The research undertaken by the Network, the Hubs and the Working Groups addresses how clinical trials are conducted and provides a research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials. This is also likely to benefit trials outside the UK.
How will they benefit from this research?
We will continue to ensure engagement between stakeholders and the Network, in particular through our Working Groups. This will ensure that high priority issues are tackled and that stakeholders benefit from the collective knowledge of the Network.
Our regular meetings with the Directors of the CTUs will continue and partnerships will be extended through the Working Groups and the conduct of Network funded projects in areas identified as high priority by the CTUs.
Our main impact outside of academia is likely to be through stronger engagement with the other major source of clinical trials in the UK, namely the pharmaceutical industry. We will continue to work with the Association of British Pharmaceutical Industries, through engaging with the Experimental medicines expert network, and by attending appropriate meetings such as the R&D Conference in partnership with BIA and NOCRI. We will strengthen engagement with appropriate professional bodies (e.g. ensuring Network presence at meetings, including PSI conferences). We will provide opportunities for industry to present and participate in the Clinical Trials Methodology Conferences, ensuring their exposure to current methodological developments. We will work with Contract Research Organisations and software companies (such as Oracle Health Sciences Global Business Unit) who provide the infrastructure support for many industry trials. Further benefits will arise from the Network exploiting its capacity to act as a conduit between academia and industry, providing a link in the translational research pathway and ensuring that key issues are addressed via the Network Working Groups.
We will continue our engagement with charities, including the main funders of clinical trials in the UK: MRC, Health Technology Assessment Programme of the National Institute for Health Research, Cancer Research UK, Arthritis Research UK (ARUK), British Heart Foundation. This will build on previous collaborations, including, for example, joint funding for workshops between ARUK and the Network. Trial funders will also benefit from Network advice on the appropriate information to collect when funding is being requested for new trials, and during trials (such as in the 'go/no go' decision after a feasibility study).
The Network will continue to engage with regulatory bodies and similar agencies, including the Medicines and Health Regulatory Agency, National Institute for Health and Clinical Excellence, and the European Medicines Agency. This will ensure that the Network remains a key source of knowledge and influence in the development of new regulations.
The Network will strengthen its engagement with patient and public initiatives, including INVOLVE, which supports the involvement of the public in health and social care research. Individual Hubs have already worked with INVOLVE on issues relating to the involvement of patients in clinical trials. We will also work with the James Lind Alliance as it continues its efforts to identify shared priorities for research between patients and practitioners.
The Network will continue its work to promote good practice in clinical trials to a wide range of healthcare practitioners. This will include the provision of training in trials, publications and presentations aimed at practitioners rather than researchers, and further work to improve understanding and interpretation of the results of trials, including through systematic reviews.
Organisations
- University College London (Lead Research Organisation)
- NHS England (Collaboration)
- Liverpool School of Tropical Medicine (Collaboration)
- NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (Collaboration)
- British Medical Association (BMA) (Collaboration)
- University of Warwick (Collaboration)
- Health Research Board (HRB) (Collaboration)
- McMaster University (Collaboration)
- University of Sheffield (Collaboration)
- Queen's University (Collaboration)
- Society for Clinical Trials (Collaboration)
- UNIVERSITY OF BIRMINGHAM (Collaboration)
- West of England Academic Health Science Network (Collaboration)
- Medical Research Council (MRC) (Collaboration)
- UNIVERSITY OF SOUTHAMPTON (Collaboration)
- University of Stirling (Collaboration)
- Lancaster University (Collaboration)
- Newcastle University (Collaboration)
- University of Paris - Descartes (Collaboration)
- UKCRC Registered trials CTU network (Collaboration)
- QUEEN'S UNIVERSITY BELFAST (Collaboration)
- UNIVERSITY OF CAMBRIDGE (Collaboration)
- UNIVERSITY OF EXETER (Collaboration)
- UNIVERSITY OF OXFORD (Collaboration)
- ULSTER UNIVERSITY (Collaboration)
- UNIVERSITY OF GLASGOW (Collaboration)
- London School of Hygiene and Tropical Medicine (LSHTM) (Collaboration)
- Hub at the MRC/CRUK/BHF Clinical Trial Service Unit (Collaboration)
- SWANSEA UNIVERSITY (Collaboration)
- UNIVERSITY OF BRITISH COLUMBIA (Collaboration)
- KING'S COLLEGE LONDON (Collaboration)
- Academy of Medical Sciences (AMS) (Collaboration)
- UNIVERSITY OF EDINBURGH (Collaboration)
- UNIVERSITY OF ABERDEEN (Collaboration)
- Cardiff University (Collaboration)
- The Global Health Network (Collaboration)
- VERSUS ARTHRITIS (Collaboration)
- UNIVERSITY OF LEEDS (Collaboration)
- UNIVERSITY OF LIVERPOOL (Collaboration)
- University of Bristol (Collaboration)
- Network Rail (Collaboration)
- London School of Economics and Political Science (University of London) (Collaboration)
- University College London (Collaboration)
- University of Manchester (Collaboration)
- Trials Methodology Research Network (Collaboration)
- UNIVERSITY OF NOTTINGHAM (Collaboration)
- TransCelerate BioPharma (Collaboration)
- National Institute for Health Research (Collaboration)
- IMPERIAL COLLEGE LONDON (Collaboration)
- Farr Institute of Health Informatics Research (Collaboration)
- UK Trial Managers Network (Collaboration)
- BANGOR UNIVERSITY (Collaboration)
- ALDER HEY CHILDREN'S NHS FOUNDATION TRUST (Collaboration)
- F. Hoffmann-La Roche AG (Collaboration)
- HEALTH DATA RESEARCH UK (Collaboration)
- UNIVERSITY OF YORK (Collaboration)
Publications
Ahmed HU
(2017)
Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study.
in Lancet (London, England)
Antoniou M
(2017)
Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.
in Journal of personalized medicine
Antoniou M
(2017)
Fixed and Adaptive Parallel Subgroup-Specific Design for Survival Outcomes: Power and Sample Size.
in Journal of personalized medicine
Antoniou M
(2019)
Biomarker-guided trials: Challenges in practice
in Contemporary Clinical Trials Communications
Antoniou M
(2016)
Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.
in PloS one
Blencowe NS
(2015)
Interventions in randomised controlled trials in surgery: issues to consider during trial design.
in Trials
Blencowe NS
(2017)
Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.
in Clinical trials (London, England)
| Description | 'How does society use evidence to judge the risks and benefits of medicines?' call for evidence |
| Geographic Reach | National |
| Policy Influence Type | Contribution to a national consultation/review |
| URL | http://www.acmedsci.ac.uk/policy/policy-projects/how-does-society-use-evidence-to-judge-the-risks-an... |
| Description | ARUK Committee- Thomas JAki approached |
| Geographic Reach | National |
| Policy Influence Type | Participation in a guidance/advisory committee |
| Description | ICTMC2015- International Clinical Trials Methodology Conference |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Impact | The ICTMC2015 reached over 600 delegates from the UK and internationally. This platform provides a unique opportunity for methodologists and trialists to meet, network, and discuss new research innovations to trials and practice. The 2015 event also included two plenary talks on the value of trials, and future funding and capacity building, and a pleary discussion session with industry on biomarker trials |
| URL | http://ictmc.uk/ |
| Description | Methodology Advisory Service for Trials |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Description | R38- Creating guidance for the costing methodology within clinical trials |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Description | R48- Clinical trials methodology: key issues for successful study design and conduct - a focussed workshop for Academic Clinical Trainees |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Description | Trials Methodology Guidance Pack- included in NIHR CT Toolkit |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Impact | The contents of the guidance pack have been linked to the NIHR CT toolkit. This is the primary resource for all those undertaking trials in the UK. Both the Network and the specific guidance pack outputs are now linked to various stations in this. This will therefore be reaching researchers accross the UK http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ http://www.ct-toolkit.ac.uk/ |
| URL | http://methodologyhubs.mrc.ac.uk/advice/network-guidance |
| Description | Benefit-Risk Assessment to Inform Non-Inferiority and Superiority study design (BRAINS) |
| Amount | £49,853 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2018 |
| End | 04/2020 |
| Description | Costing Adaptive Trials (CAT): developing best practice for CTUs supporting adaptive trials |
| Amount | £55,629 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2019 |
| End | 10/2021 |
| Description | Designing and analysing multi-arm multi-stage clinical trials with one or more endpoints |
| Amount | £443,152 (GBP) |
| Funding ID | MR/J004979/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 08/2012 |
| End | 06/2016 |
| Description | Developing efficient perpetual platform trials to study multiple treatments and multiple biomarkers |
| Amount | £228,041 (GBP) |
| Funding ID | MR/N028171/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 02/2017 |
| End | 01/2020 |
| Description | MRC MRP |
| Amount | £501,765 (GBP) |
| Funding ID | MR/R013748/1 torgerson |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | |
| Description | ORRCA HRB-TMRN Network Award |
| Amount | € 30,000 (EUR) |
| Organisation | Health Research Board (HRB) |
| Sector | Public |
| Country | Ireland |
| Start | 01/2020 |
| End | 12/2022 |
| Description | Patch Augmented Rotator Cuff Surgery (PARCS) - A feasibility study. |
| Amount | £195,346 (GBP) |
| Funding ID | 15/103/03 |
| Organisation | National Institute for Health Research |
| Department | Health Technology Assessment Programme (HTA) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2016 |
| End | 12/2018 |
| Description | Patient-centred trials: developing measures to improve the experience of people taking part in clinical trials |
| Amount | £147,094 (GBP) |
| Funding ID | PB-PG-0416-20033 |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 02/2018 |
| End | 07/2020 |
| Description | Trials Methodology Research Partnership |
| Amount | £458,666 (GBP) |
| Funding ID | MR/S014357/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2019 |
| End | 05/2022 |
| Description | What is the value of adaptive designs? Estimating expected value of sample information for adaptive trial designs. |
| Amount | £510,646 (GBP) |
| Funding ID | MR/S036709/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | |
| End | 12/2022 |
| Title | BiGTeD |
| Description | To improve the understanding of the various biomarker-guided trial designs and provide valuable and much-needed guidance on their implementation we are developing a user-friendly online tool (www.BiGTeD.org). BiGTeD provides an easily accessible resource to inform on the most optimal design when embarking on a biomarker-guided trial including easy to navigate graphical displays of the various trial designs. An overview of each design's key characteristics, methodology, and pros and cons is provided. Knowledge on how to design, implement and analyse these trials is essential for testing the effectiveness of a biomarker-guided approach to treatment. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | no impact yet |
| URL | http://www.bigted.org/ |
| Title | COMET Database: Core Outcome Measures in Effectiveness Trials |
| Description | A core outcome set is the minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. The HTMR Network funded and developed the COMET database (http://www.comet-initiative.org/studies/search) which is a searchable database of completed and ongoing projects in core outcome development. The database is also a searchable repository for project protocols and other documents (such as questionnaires). The database allows the collation and maintenance of resources for core outcome set development in a publically available database. |
| Type Of Material | Biological samples |
| Year Produced | 2011 |
| Provided To Others? | Yes |
| Impact | The COMET database was launched in August, 2011. In its first three months, there were 1712 visits (including 1049 unique visitors from 53 countries) with a total of 7634 page views and 288 completed database searches. The NIHR has promoted the COMET database on its website (see http://www.nihr.ac.uk/Pages/default.aspx). In terms of impact, Professor Hywel Williams, Chair of the NIHR HTA Commissioning Board, added "Patients and professionals making decisions about health care need access to reliable evidence. The new COMET database will help researchers across the NIHR family and beyond when choosing the outcomes to include in the studies that will establish this evidence base". |
| URL | http://www.comet-initiative.org/studies/search |
| Title | CONSORT PRO Extension |
| Description | The 2013 CONSORT-PRO extension provides guidance for authors of trials describing patient-reported outcomes. Specifically, it extends five items of the CONSORT 2010 checklist to facilitate optimal reporting of RCTs in which PRO's are primary or secondary end points. |
| Type Of Material | Physiological assessment or outcome measure |
| Year Produced | 2013 |
| Provided To Others? | Yes |
| Impact | The CONSORT PRO Extension has been cited 62 times to date and has been widely endorsed by a number of stakeholders (journal editors from JAMA, the Lancet, BMJ, PloS, CMAJ and JCO and representatives from the NIHR were all involved in the development of the guidance). The International Society for Quality of Life Research has established a dedicated taskforce (co-chaired by myself and Michael Brundage) to promote implementation of the CONSORT PRO extension The CONSORT PRO Extension and downloadable checklist is available for use via the CONSORT Website: http://www.consort-statement.org/extensions/data/pro/ All UK CRC CTUs received information regarding the CONSORT PRO Extension in their Newsletter 'The Exchange' May 2013 Volume 3, ICTD Special. The work is also described on: the Clinical Trials Engagement Network http://ctengagementnetwork.com/the-consort-patient-reported-outcome-pro-extension-implications-for-clinical-trials-and-practice/ EQUATOR Network website http://www.equator-network.org/reporting-guidelines/consort-pro/ NIHR Research Design Service Resource website: http://www.rds-sc.nihr.ac.uk/resources-and-links/ The NIHR Clinical Trials Toolkit references CONSORT and extensions and provides a link to the CONSORT website (including the PRO guidance and checklist) Calvert & Brundage are members of the NIH/NIC (US) Best Practices for Integrating PROs in Oncology Clinical Trials Taskforce and are currently preparing a Webinar on Reporting of PROs in Cancer Trials. |
| URL | http://www.isoqol.org/about-isoqol/committees/best-practices-for-pros-in-randomized-clinical-trials |
| Title | DIRUM Database of Resource-Use Data Collection Instruments for Trial-based Health Economic Evaluations |
| Description | Methods for collecting economic data based on patient-recall within clinical trials are disparate, mostly not validated, and difficult to obtain. The HTMR Network funded and developed DIRUM, which is a practical, open-access database of resource-use questionnaires for health economic evaluations of trials. The database supports data navigation, sorting, searching, and advanced filtering. For administrators, the database supports record addition, modification, deletion, and file uploads. The database can be found here: http://www.dirum.org/instruments/search |
| Type Of Material | Biological samples |
| Year Produced | 2011 |
| Provided To Others? | Yes |
| Impact | By November 2011, there have been 440 downloads of instruments from the DIRUM website, with 1971 visits from 61 countries. |
| URL | http://www.dirum.org/instruments/search |
| Title | Guidance Pack for Trials Methodology |
| Description | The Network Guidance Pack is a collated resource, capturing key outputs from the Networks research project portfolio and detailing update recommendations for trialists. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2015 |
| Provided To Others? | Yes |
| Impact | The Guidance Pack has been circulated to all CTU's in the UK via the Network, and has featured in the MRC own publication "Network". The Guidance Pack has also been highlighted to resesearchers at the Society for Clinical Trials in the US. The Guidance Pack was promoted at the conference, ICTMC2015, to over 600 active trialists from the UK and overseas |
| URL | http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ |
| Title | Interactive website for outcome reporting bias research |
| Description | The ORBIT (Outcome Reporting Bias in Trials) website is an interactive website that aims to provide guidance on the issues surrounding this form of bias. The ORBIT website contains information on current research in this field and provides users with downloadable tools for assessing and adjusting for outcome reporting bias in systematic reviews, as well as offering a help facility for those looking for more guidance on this topic. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | no impact yet |
| URL | http://www.outcome-reporting-bias.org/ |
| Title | MODEST |
| Description | Phase I dose-escalation studies are essential to determine the safe dosing range of a novel compound. Despite the poor operating characteristics of algorithmic methods such as the 3+3 design, superior model-based strategies are still rarely used. MODEsT (MOdel-based Dose-Escalation Trials) provides an easy to use software implementation of a model-based design. A stand-along web-interface is available free of charge |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2018 |
| Provided To Others? | Yes |
| Impact | Publication in progress |
| URL | https://modest.lancaster.ac.uk/ |
| Title | ORRCA online recruitment research database |
| Description | ORRCA's new online database is a resource for trialists seeking to maximise recruitment and trial methodologists who want to explore gaps in recruitment research. Following a review of 40,000 abstracts, a team of researchers from the HTMR recruitment working group and the HRB TRMN Ireland assessed the eligibility of over 3000 full text articles and categorised their content against recruitment themes. The database currently contains 1000+ articles with new additions every week. Articles can be filtered against categories such as recruitment theme, research methods, health area, age and gender to help you find relevant research and case studies. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | no impact yet |
| URL | http://www.orrca.org.uk/ |
| Title | Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Description | A revision to the Cochrane Risk of Bias assessment tool through the development and incorporation of signalling questions that will guide the assessor to reach domain-level and outcome-level risk of bias judgements, extending its remit to cover RCTs with non-standard designs (e.g. crossover trials, cluster-randomised trials). |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | no impact yet |
| URL | https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool |
| Title | Search for Oversight Statisticians |
| Description | This is a web-based system that houses a database of statisticians working in or affiliated to UKCRC registered Clinical Trials Units. The aim of the system is to: Enable identification of statisticians with experience in clinical trials as oversight committee members Support development of less experienced statisticians by providing training and mentorship opportunities as oversight committee observers |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | no impact yet |
| URL | http://ctrc.liv.ac.uk/Tools/SOS/Home/About |
| Title | COMET Initiative- Seed funding by Network |
| Description | The COMET initiative was funded by the HTMR Network in 2010 when the NEtwork was held within the MRC CTU. "The COMET Initiative brings together researchers interested in the development and application of agreed standardised sets of outcomes" |
| Type Of Material | Database/Collection of data |
| Year Produced | 2010 |
| Provided To Others? | Yes |
| Impact | COMET is a recognised resource for trialists |
| URL | http://www.comet-initiative.org/ |
| Title | DIRUM- Database- has received three grants from the HTMR Network |
| Description | DIRUM is an open-access database of resource-use questionnaires for use by health economists involved in trial-based economic evaluations. Funded by the Medical Research Council Network of Hubs for Trial Methodology Research, DIRUM also provides a repository of methodological papers related to resource use and cost measurement. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2011 |
| Provided To Others? | Yes |
| Impact | DIRUM is a recognised trial resource |
| URL | http://www.dirum.org/ |
| Description | Academy of Medical Sciences- methodology for clinicians |
| Organisation | Academy of Medical Sciences (AMS) |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Collaboration to develop a training day for clinicians in basic trials methodology |
| Collaborator Contribution | Joint project development between methodologists in the Network and the Academy. A project is in development for potential funding |
| Impact | Developing and funding of project R48 to host a workshop targetted at NIHR ACL |
| Start Year | 2013 |
| Description | Adaptive Designs TMRP working group |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | NA |
| Collaborator Contribution | The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge). |
| Impact | tbc |
| Start Year | 2019 |
| Description | Adaptive Designs TMRP working group |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | NA |
| Collaborator Contribution | The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge). |
| Impact | tbc |
| Start Year | 2019 |
| Description | Adaptive Designs Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supported the Adaptive Designs Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope: The Adaptive Designs Working Group collaborates to increase uptake of methods, to improve knowledge and to link with key stakeholders such as regulators and industry in this important area for improving the speed and efficiency of trials. Future objectives: The Network plays a vital role in increasing the implementation of adaptive design methodology, with the main barriers to implementation already identified as a lack of software and a lack of expertise. The future plans for this group include continued annual meetings, strengthening the engagement with industry and the development of collaborative inter-Hub visits to develop novel adaptive designs. The group is focusing its efforts on preparing tutorial papers for applied journals and mainstream medical journals; presentations and lectures to increase uptake of methods among stakeholders; and the development of computer software to help researchers to undertake trials with adaptive designs. |
| Impact | Adaptive designs meet regularly and host an annual meeting on their research. There is an adaptive design outreach officer - paid for by the Network- who is undertaking regular visits to CTUs and is working on new research methodologies. To date (2016 Feb) 7 CTUs have been visited, and they have collaborated with one group on developing a trial application |
| Start Year | 2010 |
| Description | B1(2) - Adaptive designs Outreach Officer continuation |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs. |
| Impact | na |
| Start Year | 2017 |
| Description | B1(2) - Adaptive designs Outreach Officer continuation |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network provided funding |
| Collaborator Contribution | One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs. |
| Impact | na |
| Start Year | 2017 |
| Description | B1(2) - Adaptive designs Outreach Officer continuation |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs. |
| Impact | na |
| Start Year | 2017 |
| Description | B1(2) - Adaptive designs Outreach Officer continuation |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs. |
| Impact | na |
| Start Year | 2017 |
| Description | B1- Big Idea- Adaptive Design Outreach officer |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this post |
| Collaborator Contribution | This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs |
| Impact | ongoing |
| Start Year | 2014 |
| Description | B1- Big Idea- Adaptive Design Outreach officer |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this post |
| Collaborator Contribution | This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs |
| Impact | ongoing |
| Start Year | 2014 |
| Description | B1- Big Idea- Adaptive Design Outreach officer |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this post |
| Collaborator Contribution | This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs |
| Impact | ongoing |
| Start Year | 2014 |
| Description | B2- Big Idea- Recruitment |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for development of new resource |
| Collaborator Contribution | The aim of this project is to develop a resource that will promote the use of existing methodological research on recruitment, allow gaps in evidence to be targeted by future research, and reduce waste in research by reducing duplication and promoting collaboration. The key output of this project will be the production of a central resource with a web interface that will allow searches to be conducted across a database housing research relevant to recruitment. The systematic schema that will be developed and used to categorise the areas of research will allow under researched areas to be identified and targeted for development of grant applications. It will also allow collaborations to stem from identification of groups currently working in isolation but with interests in similar areas thereby facilitating cross Hub and external collaborations. This has potential to underpin further grant applications. This project will also lead to the development of a funding application targeting research priority of the recruitment working group. |
| Impact | ongoing- a new staff member was recruited to support this event. Website likely to be live in 2015 |
| Start Year | 2014 |
| Description | COMET: Core Outcome Measures in Effectiveness Trials |
| Organisation | University of Oxford |
| Department | Department of Statistics |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network funded and developed the COMET database (http://www.comet-initiative.org/studies/search) which is a searchable database of completed and ongoing projects in core outcome development. The database is also a searchable repository for project protocols and other documents (such as questionnaires). The database allows the collation and maintenance of resources for core outcome set development in a publically available database.The HTMR also funded a two day workshop on developing core outcome measures. |
| Collaborator Contribution | The input from the Centre for Statistics in Medicine was relevant to developing core outcome sets. |
| Impact | The COMET database was launched in August, 2011. In its first three months, there were 1712 visits (including 1049 unique visitors from 53 countries) with a total of 7634 page views and 288 completed database searches. The database was promoted on the NIHR website: http://www.nihr.ac.uk/Pages/default.asp Professor Hywel Williams, Chair of the NIHR HTA Commissioning Board added 'Patients and professionals making decisions about health care need access to reliable evidence. The new COMET database will help researchers across the NIHR family and beyond when choosing the outcomes to include in the studies that will establish this evidence base.' New paper PLoS One. 2016 Jan 19;11 |
| Start Year | 2010 |
| Description | Collaboration with Roche to delivery a biomarkers session at ICTMC2015 |
| Organisation | F. Hoffmann-La Roche AG |
| Country | Global |
| Sector | Private |
| PI Contribution | Collaborative development of workshop session at ICTMC2015 with Roche. Leading to further potential collaboration and engagement with industry |
| Collaborator Contribution | Collaborative development of workshop session at ICTMC2015 with Roche. Leading to further potential collaboration and engagement with industry |
| Impact | Plenary at ICTMC2015- session 2. This session included a joint presentation and discussion with representatives from industry and academia |
| Start Year | 2015 |
| Description | Collaboration with the SCT to develop 2017 joint conference |
| Organisation | Society for Clinical Trials |
| Country | United States |
| Sector | Charity/Non Profit |
| PI Contribution | The HTMR Network will be working with the SCT to develop a joint conference focussed on trials methodology research in 2017- Liverpool |
| Collaborator Contribution | The HTMR Network will be working with the SCT to develop a joint conference focussed on trials methodology research in 2017- Liverpool |
| Impact | ongoing collaboration |
| Start Year | 2014 |
| Description | Collaboration with the TMRN- Ireland |
| Organisation | Trials Methodology Research Network |
| Country | Ireland |
| Sector | Private |
| PI Contribution | Collaboration and engagement with the HRB-TMRN in Ireland. Network has provided advice on MAST service, webinars and set up of Network. The Network coordinator has attended their inaugural meeting and regularly liaises with the TMRN coordinator. |
| Collaborator Contribution | The TMRN promote Network activities in Ireland. They highlight our workshops, webinars and conference and regularly engage with us. |
| Impact | The TMRN students attended the Network student symposia in 2015. |
| Start Year | 2015 |
| Description | DIRUM |
| Organisation | Bangor University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding support for establishment and development of new database. Further Network funding was provided for this work in 2013 (ref R51) Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool |
| Collaborator Contribution | DIRUM has expanded from 38 resource use measures to 60. Draft paper in development, expected to be submitted summer 2013 Further Network funding was provided for this work in 2013 (ref R51) |
| Impact | publications and presentations at conference including: • Ridyard CH, Hughes DA; DIRUM Team. Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012 Jul;15(5):650-5 • Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Applied Health Economics and Health Policy (in press) • DIRUM demonstrations at the Cancer Outcomes Conference, Hilton Birmingham Metropole, June 2012; and at the Welsh Health Economics Group meetings at Bangor University, December 2012 and Swansea University, June 2012. • Joanna Thorn presented on "Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review" at the Annual meeting of the HTMR at Oxford on 4th February 2013. - Since going live in June 2011, the database has had over 13,000 visits with over a third of these coming from outside the UK. To date, the database now contains 73 resource use measures which have been downloaded over 3700 times. - Between 2012-14, DIRUM has been a cited in the protocols involved in 8 NIHR HTA funded clinical trials securing grants to the total value of £5.4 million [1]. For example, in the PRACTICE and Cardiff breastfeeding trials, DIRUM will help inform the development of the resource use questionnaires used to study the health economics [2], whereas in the LASER trial, a patient RUM will be developed for inclusion in DIRUM and validated by comparing recorded hospital resource use with reported patient resource use. [3] - DIRUM is signposted from the NIHR Research Design Service websites as a resource for trial health economists. DIRUM has been cited in at least 32 peer-reviewed publications and is referenced in CTU standard operating procedures and key texts in economic evaluation. [4-6] - A review of DIRUM instruments has been published in the 2015 PSSRU unit cost manual, which has an estimated number of readers reaching 11,000 and the volumes cited in 65% of English health and social care economic evaluations. [7] - Several related methodological projects have emerged as a consequence of the DIRUM database. These include the development of a single modular resource use measure (HTMR Ref N57), and the compilation of 90 methodological research papers concerning cost analyses in clinical trials. DIRUM also forms part of a substantive review of methods in trial-based economic evaluation [8]. - DIRUM is cited in a number of proposals submitted to the HTA to help secure funding [e.g. 9,10] |
| Start Year | 2010 |
| Description | DIRUM |
| Organisation | London School of Economics and Political Science (University of London) |
| Department | LSE Health and Social Care |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding support for establishment and development of new database. Further Network funding was provided for this work in 2013 (ref R51) Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool |
| Collaborator Contribution | DIRUM has expanded from 38 resource use measures to 60. Draft paper in development, expected to be submitted summer 2013 Further Network funding was provided for this work in 2013 (ref R51) |
| Impact | publications and presentations at conference including: • Ridyard CH, Hughes DA; DIRUM Team. Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012 Jul;15(5):650-5 • Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Applied Health Economics and Health Policy (in press) • DIRUM demonstrations at the Cancer Outcomes Conference, Hilton Birmingham Metropole, June 2012; and at the Welsh Health Economics Group meetings at Bangor University, December 2012 and Swansea University, June 2012. • Joanna Thorn presented on "Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review" at the Annual meeting of the HTMR at Oxford on 4th February 2013. - Since going live in June 2011, the database has had over 13,000 visits with over a third of these coming from outside the UK. To date, the database now contains 73 resource use measures which have been downloaded over 3700 times. - Between 2012-14, DIRUM has been a cited in the protocols involved in 8 NIHR HTA funded clinical trials securing grants to the total value of £5.4 million [1]. For example, in the PRACTICE and Cardiff breastfeeding trials, DIRUM will help inform the development of the resource use questionnaires used to study the health economics [2], whereas in the LASER trial, a patient RUM will be developed for inclusion in DIRUM and validated by comparing recorded hospital resource use with reported patient resource use. [3] - DIRUM is signposted from the NIHR Research Design Service websites as a resource for trial health economists. DIRUM has been cited in at least 32 peer-reviewed publications and is referenced in CTU standard operating procedures and key texts in economic evaluation. [4-6] - A review of DIRUM instruments has been published in the 2015 PSSRU unit cost manual, which has an estimated number of readers reaching 11,000 and the volumes cited in 65% of English health and social care economic evaluations. [7] - Several related methodological projects have emerged as a consequence of the DIRUM database. These include the development of a single modular resource use measure (HTMR Ref N57), and the compilation of 90 methodological research papers concerning cost analyses in clinical trials. DIRUM also forms part of a substantive review of methods in trial-based economic evaluation [8]. - DIRUM is cited in a number of proposals submitted to the HTA to help secure funding [e.g. 9,10] |
| Start Year | 2010 |
| Description | DIRUM |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding support for establishment and development of new database. Further Network funding was provided for this work in 2013 (ref R51) Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool |
| Collaborator Contribution | DIRUM has expanded from 38 resource use measures to 60. Draft paper in development, expected to be submitted summer 2013 Further Network funding was provided for this work in 2013 (ref R51) |
| Impact | publications and presentations at conference including: • Ridyard CH, Hughes DA; DIRUM Team. Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012 Jul;15(5):650-5 • Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Applied Health Economics and Health Policy (in press) • DIRUM demonstrations at the Cancer Outcomes Conference, Hilton Birmingham Metropole, June 2012; and at the Welsh Health Economics Group meetings at Bangor University, December 2012 and Swansea University, June 2012. • Joanna Thorn presented on "Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review" at the Annual meeting of the HTMR at Oxford on 4th February 2013. - Since going live in June 2011, the database has had over 13,000 visits with over a third of these coming from outside the UK. To date, the database now contains 73 resource use measures which have been downloaded over 3700 times. - Between 2012-14, DIRUM has been a cited in the protocols involved in 8 NIHR HTA funded clinical trials securing grants to the total value of £5.4 million [1]. For example, in the PRACTICE and Cardiff breastfeeding trials, DIRUM will help inform the development of the resource use questionnaires used to study the health economics [2], whereas in the LASER trial, a patient RUM will be developed for inclusion in DIRUM and validated by comparing recorded hospital resource use with reported patient resource use. [3] - DIRUM is signposted from the NIHR Research Design Service websites as a resource for trial health economists. DIRUM has been cited in at least 32 peer-reviewed publications and is referenced in CTU standard operating procedures and key texts in economic evaluation. [4-6] - A review of DIRUM instruments has been published in the 2015 PSSRU unit cost manual, which has an estimated number of readers reaching 11,000 and the volumes cited in 65% of English health and social care economic evaluations. [7] - Several related methodological projects have emerged as a consequence of the DIRUM database. These include the development of a single modular resource use measure (HTMR Ref N57), and the compilation of 90 methodological research papers concerning cost analyses in clinical trials. DIRUM also forms part of a substantive review of methods in trial-based economic evaluation [8]. - DIRUM is cited in a number of proposals submitted to the HTA to help secure funding [e.g. 9,10] |
| Start Year | 2010 |
| Description | DIRUM |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Midland Hub for Trials Methodology Research (MHTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding support for establishment and development of new database. Further Network funding was provided for this work in 2013 (ref R51) Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool |
| Collaborator Contribution | DIRUM has expanded from 38 resource use measures to 60. Draft paper in development, expected to be submitted summer 2013 Further Network funding was provided for this work in 2013 (ref R51) |
| Impact | publications and presentations at conference including: • Ridyard CH, Hughes DA; DIRUM Team. Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012 Jul;15(5):650-5 • Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Applied Health Economics and Health Policy (in press) • DIRUM demonstrations at the Cancer Outcomes Conference, Hilton Birmingham Metropole, June 2012; and at the Welsh Health Economics Group meetings at Bangor University, December 2012 and Swansea University, June 2012. • Joanna Thorn presented on "Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review" at the Annual meeting of the HTMR at Oxford on 4th February 2013. - Since going live in June 2011, the database has had over 13,000 visits with over a third of these coming from outside the UK. To date, the database now contains 73 resource use measures which have been downloaded over 3700 times. - Between 2012-14, DIRUM has been a cited in the protocols involved in 8 NIHR HTA funded clinical trials securing grants to the total value of £5.4 million [1]. For example, in the PRACTICE and Cardiff breastfeeding trials, DIRUM will help inform the development of the resource use questionnaires used to study the health economics [2], whereas in the LASER trial, a patient RUM will be developed for inclusion in DIRUM and validated by comparing recorded hospital resource use with reported patient resource use. [3] - DIRUM is signposted from the NIHR Research Design Service websites as a resource for trial health economists. DIRUM has been cited in at least 32 peer-reviewed publications and is referenced in CTU standard operating procedures and key texts in economic evaluation. [4-6] - A review of DIRUM instruments has been published in the 2015 PSSRU unit cost manual, which has an estimated number of readers reaching 11,000 and the volumes cited in 65% of English health and social care economic evaluations. [7] - Several related methodological projects have emerged as a consequence of the DIRUM database. These include the development of a single modular resource use measure (HTMR Ref N57), and the compilation of 90 methodological research papers concerning cost analyses in clinical trials. DIRUM also forms part of a substantive review of methods in trial-based economic evaluation [8]. - DIRUM is cited in a number of proposals submitted to the HTA to help secure funding [e.g. 9,10] |
| Start Year | 2010 |
| Description | DIRUM |
| Organisation | University of British Columbia |
| Department | Vancouver Coastal Health Research Institute |
| Country | Canada |
| Sector | Academic/University |
| PI Contribution | Network funding support for establishment and development of new database. Further Network funding was provided for this work in 2013 (ref R51) Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool |
| Collaborator Contribution | DIRUM has expanded from 38 resource use measures to 60. Draft paper in development, expected to be submitted summer 2013 Further Network funding was provided for this work in 2013 (ref R51) |
| Impact | publications and presentations at conference including: • Ridyard CH, Hughes DA; DIRUM Team. Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012 Jul;15(5):650-5 • Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Applied Health Economics and Health Policy (in press) • DIRUM demonstrations at the Cancer Outcomes Conference, Hilton Birmingham Metropole, June 2012; and at the Welsh Health Economics Group meetings at Bangor University, December 2012 and Swansea University, June 2012. • Joanna Thorn presented on "Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review" at the Annual meeting of the HTMR at Oxford on 4th February 2013. - Since going live in June 2011, the database has had over 13,000 visits with over a third of these coming from outside the UK. To date, the database now contains 73 resource use measures which have been downloaded over 3700 times. - Between 2012-14, DIRUM has been a cited in the protocols involved in 8 NIHR HTA funded clinical trials securing grants to the total value of £5.4 million [1]. For example, in the PRACTICE and Cardiff breastfeeding trials, DIRUM will help inform the development of the resource use questionnaires used to study the health economics [2], whereas in the LASER trial, a patient RUM will be developed for inclusion in DIRUM and validated by comparing recorded hospital resource use with reported patient resource use. [3] - DIRUM is signposted from the NIHR Research Design Service websites as a resource for trial health economists. DIRUM has been cited in at least 32 peer-reviewed publications and is referenced in CTU standard operating procedures and key texts in economic evaluation. [4-6] - A review of DIRUM instruments has been published in the 2015 PSSRU unit cost manual, which has an estimated number of readers reaching 11,000 and the volumes cited in 65% of English health and social care economic evaluations. [7] - Several related methodological projects have emerged as a consequence of the DIRUM database. These include the development of a single modular resource use measure (HTMR Ref N57), and the compilation of 90 methodological research papers concerning cost analyses in clinical trials. DIRUM also forms part of a substantive review of methods in trial-based economic evaluation [8]. - DIRUM is cited in a number of proposals submitted to the HTA to help secure funding [e.g. 9,10] |
| Start Year | 2010 |
| Description | Enagement with NIHR CRN Industry collaborative |
| Organisation | National Institute for Health Research |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Engagement and discussion with Lydia Christopher, Head of Industry Operations at the National Institute for Health Research (NIHR) Clinical Research Network, |
| Collaborator Contribution | Lydia Christopher, Head of Industry Operations at the National Institute for Health Research (NIHR) Clinical Research Network attended a discussion meeting with the NEtwork to consider our focus and engagement with industry in trials |
| Impact | ongoing discussions |
| Start Year | 2014 |
| Description | Engagement with UKCRN CTU Network |
| Organisation | National Institute for Health Research |
| Department | Comprehensive Clinical Research Network (Coordinating Centre) – NIHR |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | We work closely with the UK CRN CTU Directors. Members of the HTMR Network have presented at their meetings. We are also working closely to share information in our respective newsletters. |
| Collaborator Contribution | Reciprocal discussions on pertinent issues. Distribution of shared information to Network members and highlighted pieces in newsletters. |
| Impact | Highlight of the HTMR Network in UKCRN newsletters and also presentation at November CTU Directors meeting. |
| Start Year | 2012 |
| Description | Evidence Synthesis Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Evidence Synthesis Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Evidence Synthesis Working Group focuses on the use of evidence synthesis, or systematic reviews, in the design, monitoring and interpretation of trials. Future Objectives- The Working Group is preparing a series of papers to help trialists and others to make best use of evidence synthesis, including those based on the central collection and re-analysis of participant level data. It will develop clear recommendations for how evidence synthesis can be used in the design, conduct, and analysis of trials with a view to increasing the use of these methods in practice and reducing the waste in research that can arise when proper notice is not paid to existing evidence. "Position papers" will bring together work on the use of evidence synthesis in trial design, conduct and analysis in general, and compare methods for using evidence synthesis when estimating sample size requirements for new trials, using the Corticosteroid Randomisation After Significant Head injury (CRASH) trial as a worked example. Members of the Working Group are also collaborating to adapt the established principles for systematic reviews of trials to apply them elsewhere in the process of translational research, including within animal studies, evaluations of diagnostic tests and of prognostic models, and research to identify biomarkers and surrogate endpoints that might be used in trials. |
| Impact | Ongoing activities. Hosting a session as part of the HTMR annual meeting |
| Start Year | 2010 |
| Description | HTMR and Transcelerate- working relationship |
| Organisation | TransCelerate BioPharma |
| Country | United States |
| Sector | Private |
| PI Contribution | This is a new collaboration for the HTMR Network, engaging with the work of Transcelerate. Transcelerate is a not for profit industry led organisation, focussing on review of methods in industry based clinical trials. |
| Collaborator Contribution | To date (Oct 2014) we have held one meeting and one teleconference to discuss areas of potential overlap and collaboration. We will be pursuing this further in 2015, with planning engagement on specific projects. |
| Impact | none to date |
| Start Year | 2014 |
| Description | Health Economics Working Group |
| Organisation | Network Rail Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | The HTMR Network supports the Health Economics Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Health Economics Resource Use and Costs Working Group brings together health economists, within the MRC Hubs for Trials Methodology Research and across the UK, and other important stake holders from NHS trust finance departments and government bodies. Its aim is to improve methods for resource-use measurement, costing and analysis in randomised controlled trials (RCTs) through collaborative methodological research and dissemination. Future Objectives- The Health Economics Working Group was established in 2014, and aims to engage and include health economists and representatives from NHS finance, HSCIC, NICE and OHE to join the working group. The Working Group will develop its portfolio by applying for Methodology Research Panel funding from the MRP, and for workshop funding from the HTMR Network. The Health Economics Working Group encompasses the team driving the DIRUM website, and will develop this resource further to include relevant material making it a primary resource for health economists involved with trial-based economic evaluation. |
| Impact | Collaborative meetings and teleconferences |
| Start Year | 2014 |
| Description | Health Informatics Working Group |
| Organisation | Farr Institute of Health Informatics Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Health Informatics Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Health Informatics Working Group will undertake methodological and applied research to harness advanced health informatics and electronic health record (EHR) data to improve the design and conduct of trials, and develop capacity in this area. This use of health informatics will also be evaluated to identify the benefit, when compared to current non-EHR approaches. The Working Group will also consider regulatory impacts on the use of bioinformatics (e.g. the interaction of long term follow-up via medical records and the requirements for Information Governance Toolkit certification). Future Objectives- The Working Group aims to establish collaborations with the UK Health Informatics Research Network, and will continue to collaborate with the UKCRC Registered Clinical Trials Unit (CTU) Network; linking methodologists and practitioners to maximise impact. Future research will examine the potential of EHR to; • improve the assessment of feasibility of trial recruitment, • model expected recruitment over the course of a trial, to identify participants for screening via EHR alerts, and • be the primary source of patient outcome and resource use data. We will develop the informatics understanding of how best to collect electronic Patient-Reported Outcomes (ePROs) in trials, both in clinical settings and remotely from patients' homes via web based applications, mobile phones and tablet computers. We will document the added value of ePROs for clinical trials, working where appropriate with industry and regulatory authorities. Working with others, we will establish good practice for sharing of individual participant data from trials. |
| Impact | Workshop held in 2014. |
| Start Year | 2014 |
| Description | Health Informatics Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Health Informatics Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Health Informatics Working Group will undertake methodological and applied research to harness advanced health informatics and electronic health record (EHR) data to improve the design and conduct of trials, and develop capacity in this area. This use of health informatics will also be evaluated to identify the benefit, when compared to current non-EHR approaches. The Working Group will also consider regulatory impacts on the use of bioinformatics (e.g. the interaction of long term follow-up via medical records and the requirements for Information Governance Toolkit certification). Future Objectives- The Working Group aims to establish collaborations with the UK Health Informatics Research Network, and will continue to collaborate with the UKCRC Registered Clinical Trials Unit (CTU) Network; linking methodologists and practitioners to maximise impact. Future research will examine the potential of EHR to; • improve the assessment of feasibility of trial recruitment, • model expected recruitment over the course of a trial, to identify participants for screening via EHR alerts, and • be the primary source of patient outcome and resource use data. We will develop the informatics understanding of how best to collect electronic Patient-Reported Outcomes (ePROs) in trials, both in clinical settings and remotely from patients' homes via web based applications, mobile phones and tablet computers. We will document the added value of ePROs for clinical trials, working where appropriate with industry and regulatory authorities. Working with others, we will establish good practice for sharing of individual participant data from trials. |
| Impact | Workshop held in 2014. |
| Start Year | 2014 |
| Description | Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects. |
| Impact | tbc |
| Start Year | 2019 |
| Description | Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects. |
| Impact | tbc |
| Start Year | 2019 |
| Description | Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects. |
| Impact | tbc |
| Start Year | 2019 |
| Description | Methodological issues in trials funded by Arthritis Research UK |
| Organisation | Versus Arthritis |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | The HTMR Network offered access to the Methodology Advisory Service for Trials (MAST), and offered to review the funding application forms of ARUK. Update 2014- The Network has reengaged with this group and will be presenting at their autumn Clinical Study Group leads meeting |
| Collaborator Contribution | Discussions between ARUK and the HTMR Network have identified a number of methodological issues that could be addressed in trials methodology. Update 2014- The Network has reengaged with this group and will be presenting at their autumn Clinical Study Group leads meeting Update 2015- following a previously joint funded research project a publication is now available: 10.1007/s40744-015-0020-0 |
| Impact | This collaboration has highlighted that guidance is needed on: 1. Design of non-inferiority trials. These trials could be sign-posted to the HTMR Network's Methodology Advisory Service for Trials (MAST). 2. Advise on the choice of endpoints in the arthritis field, which can vary over time and include composite scores. 3. Biologics: guidance on how to approach studies of tapering/stopping biologics as these studies are methodologically challenging. 4. The use of biomarkers to detect a response to a biologic (i.e. who should get a particular biologic?) 5. Trial monitoring practices. 6. Assess how achievable and realistic a recruitment target is. This information has enabled the HTMR Network to prioritise working groups to address these issues. Guidance documents are in preparation for some of these issues. Published guidance doc: 10.1007/s40744-015-0020-0 |
| Start Year | 2011 |
| Description | Methodological issues in trials funded by NIHR Health Technology Assessment Programme |
| Organisation | National Institute for Health Research |
| Department | Health Technology Assessment Programme (HTA) |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | The HTMR Network offered access to the Methodology Advisory Service for Trials (MAST), and offered to review the funding application forms of HTA. |
| Collaborator Contribution | Discussions between HTA and the HTMR Network have identified a number of methodological issues that could be addressed in trials methodology. |
| Impact | This collaboration has enabled the HTMR Network to prioritise working groups to address methodological issues. Guidance documents are in preparation and will be submitted for publication for some of issues below: 1. Non-inferiority trials. 2. Adaptive designs. 3. Outcomes (especially composite outcomes). 4. Diagnostic tests and prediction rules. 5. Design of trials of complex interventions. 6. Factorial designs, particularly with complex interventions. 7. Design of cluster randomised trials. 8. Trials where recruitment or retention is difficult. |
| Start Year | 2011 |
| Description | N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this. |
| Impact | tba |
| Start Year | 2017 |
| Description | N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this. |
| Impact | tba |
| Start Year | 2017 |
| Description | N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. |
| Organisation | West of England Academic Health Science Network |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this. |
| Impact | tba |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | Health Research Board (HRB) |
| Country | Ireland |
| Sector | Public |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided funding |
| Collaborator Contribution | Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel. |
| Impact | na |
| Start Year | 2019 |
| Description | N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel. |
| Impact | na |
| Start Year | 2019 |
| Description | N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel. |
| Impact | na |
| Start Year | 2019 |
| Description | N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel. |
| Impact | na |
| Start Year | 2019 |
| Description | N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel. |
| Impact | na |
| Start Year | 2019 |
| Description | N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document |
| Organisation | University College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations. |
| Impact | na |
| Start Year | 2019 |
| Description | N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations. |
| Impact | na |
| Start Year | 2019 |
| Description | N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | n/a |
| Collaborator Contribution | A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations. |
| Impact | na |
| Start Year | 2019 |
| Description | N105 Impact award Practicalities in running trials with more than one primary hypothesis and an adaptive element (Platform trials |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | na |
| Collaborator Contribution | With the help of funding from the Trial Conduct Working Group we ran a day discussing the practicalities of running platform trials (defined as trials with more than one primary hypothesis and an adaptive element). We invited 27 statisticians, trial managers and Chief investigators from 21 platform trials in a structured day with a different attendee leading each of the 15 sessions. The discussion has been written up in a paper form by 15 different authors. We would like an editor with 5 years experience in editing such papers to make the paper speak with one voice. To do this we would need to pay for her time. There would be more work from Sharon Love after this edit to finalise changes and then another round of reviews from the authors |
| Impact | na a publication is expected |
| Start Year | 2019 |
| Description | N55- Development of a quality assessment tool for core outcome set development |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project - |
| Collaborator Contribution | A review of the literature has identified core outcome sets in nearly 200 medical conditions, and we are also aware of over 30 ongoing projects. COMET has put this information together in a publically available, searchable database. To date there has been no formal quality assessment of these studies and there is a pressing need to do so using internationally recognised criteria, both for COS developers and for trialists using COS. This proposal requests funds to host a consensus meeting which is part of a larger study to develop the quality assessment instrument for studies developing COS. The outputs could impact immediately on the increasing number of ongoing and planned COS studies. |
| Impact | none to date |
| Start Year | 2014 |
| Description | N55- Development of a quality assessment tool for core outcome set development |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project - |
| Collaborator Contribution | A review of the literature has identified core outcome sets in nearly 200 medical conditions, and we are also aware of over 30 ongoing projects. COMET has put this information together in a publically available, searchable database. To date there has been no formal quality assessment of these studies and there is a pressing need to do so using internationally recognised criteria, both for COS developers and for trialists using COS. This proposal requests funds to host a consensus meeting which is part of a larger study to develop the quality assessment instrument for studies developing COS. The outputs could impact immediately on the increasing number of ongoing and planned COS studies. |
| Impact | none to date |
| Start Year | 2014 |
| Description | N55- Development of a quality assessment tool for core outcome set development |
| Organisation | Queen's University Belfast |
| Department | The All-Ireland Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project - |
| Collaborator Contribution | A review of the literature has identified core outcome sets in nearly 200 medical conditions, and we are also aware of over 30 ongoing projects. COMET has put this information together in a publically available, searchable database. To date there has been no formal quality assessment of these studies and there is a pressing need to do so using internationally recognised criteria, both for COS developers and for trialists using COS. This proposal requests funds to host a consensus meeting which is part of a larger study to develop the quality assessment instrument for studies developing COS. The outputs could impact immediately on the increasing number of ongoing and planned COS studies. |
| Impact | none to date |
| Start Year | 2014 |
| Description | N55- Development of a quality assessment tool for core outcome set development |
| Organisation | University of Oxford |
| Department | Centre for Statistics in Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project - |
| Collaborator Contribution | A review of the literature has identified core outcome sets in nearly 200 medical conditions, and we are also aware of over 30 ongoing projects. COMET has put this information together in a publically available, searchable database. To date there has been no formal quality assessment of these studies and there is a pressing need to do so using internationally recognised criteria, both for COS developers and for trialists using COS. This proposal requests funds to host a consensus meeting which is part of a larger study to develop the quality assessment instrument for studies developing COS. The outputs could impact immediately on the increasing number of ongoing and planned COS studies. |
| Impact | none to date |
| Start Year | 2014 |
| Description | N57 Impact award Identification of items for inclusion in a standardised resource-use measure |
| Organisation | Bangor University |
| Department | Centre for Health Economics and Medicines Evaluation |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The Network provided funding |
| Collaborator Contribution | The ISRUM project (Items for a Standardised Resource-Use Measure) aimed to determine a core list of essential resource-use items (such as GP appointments or hospital stays) that should be included in a standardised generic resource-use questionnaire for use in economic evaluations conducted alongside randomised controlled trials (RCTs) in the UK. At present, resource-use measures are largely developed on an ad hoc trial-by-trial basis, leading to sub-optimal methods and duplicated work. The ISRUM project used Delphi methodology to achieve a consensus opinion from health economists on the key items for inclusion: ten items relevant to the National Health Service were identified as essential. A standardised instrument based on the output from ISRUM would improve the conduct and comparability of economic evaluations conducted alongside RCTs; work to develop the ISRUM instrument is currently being undertaken by a hub-funded PhD student. In order for health economists to choose to use the instrument, it is important that good results can be obtained from patients responding to the questionnaire. The design of an appealing layout will facilitate the uptake of the questionnaire; we therefore plan to engage a professional design company to ensure that the 'look and feel' of the questionnaire is modern and appealing to both researchers and patients. Kirsty Garfield, will present the ISRUM Resource at the International Society for Pharmacoeconomics and Outcomes Research European Congress in November 2019, . This will enable us to introduce the instrument to a wide range of researchers and promote its use in RCTs, to seek collaborators for validation studies, and to disseminate the pilot work. |
| Impact | No Impact Yet |
| Start Year | 2018 |
| Description | N57 Impact award Identification of items for inclusion in a standardised resource-use measure |
| Organisation | University of Bristol |
| Department | School of Social and Community Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The Network provided funding |
| Collaborator Contribution | The ISRUM project (Items for a Standardised Resource-Use Measure) aimed to determine a core list of essential resource-use items (such as GP appointments or hospital stays) that should be included in a standardised generic resource-use questionnaire for use in economic evaluations conducted alongside randomised controlled trials (RCTs) in the UK. At present, resource-use measures are largely developed on an ad hoc trial-by-trial basis, leading to sub-optimal methods and duplicated work. The ISRUM project used Delphi methodology to achieve a consensus opinion from health economists on the key items for inclusion: ten items relevant to the National Health Service were identified as essential. A standardised instrument based on the output from ISRUM would improve the conduct and comparability of economic evaluations conducted alongside RCTs; work to develop the ISRUM instrument is currently being undertaken by a hub-funded PhD student. In order for health economists to choose to use the instrument, it is important that good results can be obtained from patients responding to the questionnaire. The design of an appealing layout will facilitate the uptake of the questionnaire; we therefore plan to engage a professional design company to ensure that the 'look and feel' of the questionnaire is modern and appealing to both researchers and patients. Kirsty Garfield, will present the ISRUM Resource at the International Society for Pharmacoeconomics and Outcomes Research European Congress in November 2019, . This will enable us to introduce the instrument to a wide range of researchers and promote its use in RCTs, to seek collaborators for validation studies, and to disseminate the pilot work. |
| Impact | No Impact Yet |
| Start Year | 2018 |
| Description | N57 Impact award Identification of items for inclusion in a standardised resource-use measure |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The Network provided funding |
| Collaborator Contribution | The ISRUM project (Items for a Standardised Resource-Use Measure) aimed to determine a core list of essential resource-use items (such as GP appointments or hospital stays) that should be included in a standardised generic resource-use questionnaire for use in economic evaluations conducted alongside randomised controlled trials (RCTs) in the UK. At present, resource-use measures are largely developed on an ad hoc trial-by-trial basis, leading to sub-optimal methods and duplicated work. The ISRUM project used Delphi methodology to achieve a consensus opinion from health economists on the key items for inclusion: ten items relevant to the National Health Service were identified as essential. A standardised instrument based on the output from ISRUM would improve the conduct and comparability of economic evaluations conducted alongside RCTs; work to develop the ISRUM instrument is currently being undertaken by a hub-funded PhD student. In order for health economists to choose to use the instrument, it is important that good results can be obtained from patients responding to the questionnaire. The design of an appealing layout will facilitate the uptake of the questionnaire; we therefore plan to engage a professional design company to ensure that the 'look and feel' of the questionnaire is modern and appealing to both researchers and patients. Kirsty Garfield, will present the ISRUM Resource at the International Society for Pharmacoeconomics and Outcomes Research European Congress in November 2019, . This will enable us to introduce the instrument to a wide range of researchers and promote its use in RCTs, to seek collaborators for validation studies, and to disseminate the pilot work. |
| Impact | No Impact Yet |
| Start Year | 2018 |
| Description | N57- Identification of items for inclusion in a standardised resource-use measure |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding- for project- detailed below |
| Collaborator Contribution | Aim: To identify a core set of economically important resource-use items that are suitable for future inclusion in a modular patient-reported resource-use measure. Methods: Instruments currently lodged in DIRUM (the Database of Instruments for Resource-Use Measurement, www.dirum.org), and additional instruments sourced from health economists, will be examined to determine the items of resource use that are commonly collected in RCTs. A comprehensive list of care items encountered will be compiled; items will then be categorised into 'domains' describing different types of healthcare (e.g. inpatient care, community care or medication). The item list will be systematically reduced to 10-20 key items per domain to form the basis for the Delphi survey. A Delphi panel comprising patients, health economists and trialists from varying backgrounds will be engaged. In round 1 of the Delphi process, professional participants will be asked to rate the items according to their economic importance in a trial context, while patients will be asked to assign ratings based on the item's relevance. Participants will also be asked to suggest additional items of healthcare resource use for consideration. Items deemed insufficiently important according to predefined criteria encompassing both professional and patient responses will be dropped. A second Delphi round will be undertaken in which feedback from the first round will be presented to participants. A third Delphi round may be conducted if significant differences of opinion remain. |
| Impact | na |
| Start Year | 2014 |
| Description | N57- Identification of items for inclusion in a standardised resource-use measure |
| Organisation | University of Oxford |
| Department | Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding- for project- detailed below |
| Collaborator Contribution | Aim: To identify a core set of economically important resource-use items that are suitable for future inclusion in a modular patient-reported resource-use measure. Methods: Instruments currently lodged in DIRUM (the Database of Instruments for Resource-Use Measurement, www.dirum.org), and additional instruments sourced from health economists, will be examined to determine the items of resource use that are commonly collected in RCTs. A comprehensive list of care items encountered will be compiled; items will then be categorised into 'domains' describing different types of healthcare (e.g. inpatient care, community care or medication). The item list will be systematically reduced to 10-20 key items per domain to form the basis for the Delphi survey. A Delphi panel comprising patients, health economists and trialists from varying backgrounds will be engaged. In round 1 of the Delphi process, professional participants will be asked to rate the items according to their economic importance in a trial context, while patients will be asked to assign ratings based on the item's relevance. Participants will also be asked to suggest additional items of healthcare resource use for consideration. Items deemed insufficiently important according to predefined criteria encompassing both professional and patient responses will be dropped. A second Delphi round will be undertaken in which feedback from the first round will be presented to participants. A third Delphi round may be conducted if significant differences of opinion remain. |
| Impact | na |
| Start Year | 2014 |
| Description | N61 Impact Award: Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | HTMR Network provided funding £9971 |
| Collaborator Contribution | The aim of this impact project is to facilitate implementation of RoB 2.0 by producing an interactive, easy-to-use online version in which structure, guidance and a suite of informative examples are seamlessly integrated. We will develop a web application for risk-of-bias assessments with interactive help, including linked examples. The implementation will display only the signalling questions that are relevant based on previous answers, and facilitate assessment by displaying relevant information succinctly on-screen. It will apply decision algorithms to suggest domain-level judgements based on users' answers to signalling questions. The web application will make the tool easier to use, which will increase its uptake. In addition, deposited risk-of-bias assessments of large numbers of trials could be used for machine learning and meta-epidemiological research, to improve transparency of clinical research and decrease research waste. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N61 Impact Award: Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | University of Bristol |
| Department | School of Social and Community Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network provided funding £9971 |
| Collaborator Contribution | The aim of this impact project is to facilitate implementation of RoB 2.0 by producing an interactive, easy-to-use online version in which structure, guidance and a suite of informative examples are seamlessly integrated. We will develop a web application for risk-of-bias assessments with interactive help, including linked examples. The implementation will display only the signalling questions that are relevant based on previous answers, and facilitate assessment by displaying relevant information succinctly on-screen. It will apply decision algorithms to suggest domain-level judgements based on users' answers to signalling questions. The web application will make the tool easier to use, which will increase its uptake. In addition, deposited risk-of-bias assessments of large numbers of trials could be used for machine learning and meta-epidemiological research, to improve transparency of clinical research and decrease research waste. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N61 Impact Award: Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | University of Liverpool |
| Department | Institute of Translational Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network provided funding £9971 |
| Collaborator Contribution | The aim of this impact project is to facilitate implementation of RoB 2.0 by producing an interactive, easy-to-use online version in which structure, guidance and a suite of informative examples are seamlessly integrated. We will develop a web application for risk-of-bias assessments with interactive help, including linked examples. The implementation will display only the signalling questions that are relevant based on previous answers, and facilitate assessment by displaying relevant information succinctly on-screen. It will apply decision algorithms to suggest domain-level judgements based on users' answers to signalling questions. The web application will make the tool easier to use, which will increase its uptake. In addition, deposited risk-of-bias assessments of large numbers of trials could be used for machine learning and meta-epidemiological research, to improve transparency of clinical research and decrease research waste. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N61- Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this project. Various Network members as research participants |
| Collaborator Contribution | Randomised clinical trials (RCTs) inform healthcare policy decisions, either directly or through their inclusion in evidence syntheses. Trial validity must be assessed to ensure that synthesised evidence provides a reliable basis for decision-making. The Cochrane Risk of Bias (ROB) tool for assessment of biases in RCTs is widely used for this purpose. It is tailored for assessment of standard parallel-group trials, and only limited guidance is available for more complex designs, e.g. cross-over and cluster trials. We will refine and improve the Cochrane ROB tool for RCTs to bring it in line with recent developments in ROB assessment and expand it to include guidance on cluster and cross-over trials. We will improve the usability and robustness of the tool by adding signalling questions, which guide the assessor to consider all relevant threats to validity within each bias domain. We will provide clearer guidance for reaching an overall outcome- and study-level risk of bias judgement and on how to incorporate overall judgment into meta-analyses and review conclusions. This new structure and additional guidance will lead to more robust bias assessment and improve future trial design by highlighting biases that should be avoided. The project will include four stages: (i) Develop new version of the tool with signalling questions and associated guidelines, informed by a meeting with expert methodologists and users of current ROB tool and review of recent empirical evidence for bias; (ii) Pilot - we will host a supported piloting event where reviewers of varied experience will pilot the tool, supported by members of the development team, and provide critical feedback; (iii) Refine the final version of the tool and produce guidance, informed by piloting feedback and reliability analyses; (iv) Implementation and active dissemination of the tool through publication, provision of worked examples, and integration with Cochrane methods and procedures. |
| Impact | PMID 27398997; 27392044 |
| Start Year | 2015 |
| Description | N61- Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this project. Various Network members as research participants |
| Collaborator Contribution | Randomised clinical trials (RCTs) inform healthcare policy decisions, either directly or through their inclusion in evidence syntheses. Trial validity must be assessed to ensure that synthesised evidence provides a reliable basis for decision-making. The Cochrane Risk of Bias (ROB) tool for assessment of biases in RCTs is widely used for this purpose. It is tailored for assessment of standard parallel-group trials, and only limited guidance is available for more complex designs, e.g. cross-over and cluster trials. We will refine and improve the Cochrane ROB tool for RCTs to bring it in line with recent developments in ROB assessment and expand it to include guidance on cluster and cross-over trials. We will improve the usability and robustness of the tool by adding signalling questions, which guide the assessor to consider all relevant threats to validity within each bias domain. We will provide clearer guidance for reaching an overall outcome- and study-level risk of bias judgement and on how to incorporate overall judgment into meta-analyses and review conclusions. This new structure and additional guidance will lead to more robust bias assessment and improve future trial design by highlighting biases that should be avoided. The project will include four stages: (i) Develop new version of the tool with signalling questions and associated guidelines, informed by a meeting with expert methodologists and users of current ROB tool and review of recent empirical evidence for bias; (ii) Pilot - we will host a supported piloting event where reviewers of varied experience will pilot the tool, supported by members of the development team, and provide critical feedback; (iii) Refine the final version of the tool and produce guidance, informed by piloting feedback and reliability analyses; (iv) Implementation and active dissemination of the tool through publication, provision of worked examples, and integration with Cochrane methods and procedures. |
| Impact | PMID 27398997; 27392044 |
| Start Year | 2015 |
| Description | N61- Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | National Institute for Health Research |
| Department | NIHR CLAHRC West |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network funding provided for this project. Various Network members as research participants |
| Collaborator Contribution | Randomised clinical trials (RCTs) inform healthcare policy decisions, either directly or through their inclusion in evidence syntheses. Trial validity must be assessed to ensure that synthesised evidence provides a reliable basis for decision-making. The Cochrane Risk of Bias (ROB) tool for assessment of biases in RCTs is widely used for this purpose. It is tailored for assessment of standard parallel-group trials, and only limited guidance is available for more complex designs, e.g. cross-over and cluster trials. We will refine and improve the Cochrane ROB tool for RCTs to bring it in line with recent developments in ROB assessment and expand it to include guidance on cluster and cross-over trials. We will improve the usability and robustness of the tool by adding signalling questions, which guide the assessor to consider all relevant threats to validity within each bias domain. We will provide clearer guidance for reaching an overall outcome- and study-level risk of bias judgement and on how to incorporate overall judgment into meta-analyses and review conclusions. This new structure and additional guidance will lead to more robust bias assessment and improve future trial design by highlighting biases that should be avoided. The project will include four stages: (i) Develop new version of the tool with signalling questions and associated guidelines, informed by a meeting with expert methodologists and users of current ROB tool and review of recent empirical evidence for bias; (ii) Pilot - we will host a supported piloting event where reviewers of varied experience will pilot the tool, supported by members of the development team, and provide critical feedback; (iii) Refine the final version of the tool and produce guidance, informed by piloting feedback and reliability analyses; (iv) Implementation and active dissemination of the tool through publication, provision of worked examples, and integration with Cochrane methods and procedures. |
| Impact | PMID 27398997; 27392044 |
| Start Year | 2015 |
| Description | N61- Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this project. Various Network members as research participants |
| Collaborator Contribution | Randomised clinical trials (RCTs) inform healthcare policy decisions, either directly or through their inclusion in evidence syntheses. Trial validity must be assessed to ensure that synthesised evidence provides a reliable basis for decision-making. The Cochrane Risk of Bias (ROB) tool for assessment of biases in RCTs is widely used for this purpose. It is tailored for assessment of standard parallel-group trials, and only limited guidance is available for more complex designs, e.g. cross-over and cluster trials. We will refine and improve the Cochrane ROB tool for RCTs to bring it in line with recent developments in ROB assessment and expand it to include guidance on cluster and cross-over trials. We will improve the usability and robustness of the tool by adding signalling questions, which guide the assessor to consider all relevant threats to validity within each bias domain. We will provide clearer guidance for reaching an overall outcome- and study-level risk of bias judgement and on how to incorporate overall judgment into meta-analyses and review conclusions. This new structure and additional guidance will lead to more robust bias assessment and improve future trial design by highlighting biases that should be avoided. The project will include four stages: (i) Develop new version of the tool with signalling questions and associated guidelines, informed by a meeting with expert methodologists and users of current ROB tool and review of recent empirical evidence for bias; (ii) Pilot - we will host a supported piloting event where reviewers of varied experience will pilot the tool, supported by members of the development team, and provide critical feedback; (iii) Refine the final version of the tool and produce guidance, informed by piloting feedback and reliability analyses; (iv) Implementation and active dissemination of the tool through publication, provision of worked examples, and integration with Cochrane methods and procedures. |
| Impact | PMID 27398997; 27392044 |
| Start Year | 2015 |
| Description | N61- Refinement of and extension to the Cochrane Risk of Bias tool for Randomised trials |
| Organisation | University of Paris - Descartes |
| Country | France |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this project. Various Network members as research participants |
| Collaborator Contribution | Randomised clinical trials (RCTs) inform healthcare policy decisions, either directly or through their inclusion in evidence syntheses. Trial validity must be assessed to ensure that synthesised evidence provides a reliable basis for decision-making. The Cochrane Risk of Bias (ROB) tool for assessment of biases in RCTs is widely used for this purpose. It is tailored for assessment of standard parallel-group trials, and only limited guidance is available for more complex designs, e.g. cross-over and cluster trials. We will refine and improve the Cochrane ROB tool for RCTs to bring it in line with recent developments in ROB assessment and expand it to include guidance on cluster and cross-over trials. We will improve the usability and robustness of the tool by adding signalling questions, which guide the assessor to consider all relevant threats to validity within each bias domain. We will provide clearer guidance for reaching an overall outcome- and study-level risk of bias judgement and on how to incorporate overall judgment into meta-analyses and review conclusions. This new structure and additional guidance will lead to more robust bias assessment and improve future trial design by highlighting biases that should be avoided. The project will include four stages: (i) Develop new version of the tool with signalling questions and associated guidelines, informed by a meeting with expert methodologists and users of current ROB tool and review of recent empirical evidence for bias; (ii) Pilot - we will host a supported piloting event where reviewers of varied experience will pilot the tool, supported by members of the development team, and provide critical feedback; (iii) Refine the final version of the tool and produce guidance, informed by piloting feedback and reliability analyses; (iv) Implementation and active dissemination of the tool through publication, provision of worked examples, and integration with Cochrane methods and procedures. |
| Impact | PMID 27398997; 27392044 |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | Alder Hey Children's NHS Foundation Trust |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | National Institute for Health Research |
| Department | INVOLVE |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | University of Leeds |
| Department | Leeds Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N62- Methods for Patient and Public Involvement in Clinical Trials |
| Organisation | University of Oxford |
| Department | Nuffield Department of Population Health |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for project. Collaborators include Network Hub members |
| Collaborator Contribution | . Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. |
| Impact | non to date |
| Start Year | 2015 |
| Description | N64- Studies Within a Trial and Embedded Trials: Current barriers and facilitators to implementation in funders and clinical trials units |
| Organisation | Queen's University |
| Country | Canada |
| Sector | Academic/University |
| PI Contribution | Network funding provided and hosting for this collaboration |
| Collaborator Contribution | Various collaborative research efforts in the field of SWATS including: 1. produce a decision aid/flow diagram on how to run an embedded trial to support implementation 2. enable further work with charity funders of research by outsourcing interview transcription to free up researcher time. The research team have engaged with parties as follows:Screening survey of all registered CTUs Interviews with: • CTU leads • senior trialists • trial managers • funders Workshops with: • ICTMC 2015 participants • UKTMN 2015 conference participants Webinar with: • UKTMN members |
| Impact | none to date |
| Start Year | 2015 |
| Description | N64- Studies Within a Trial and Embedded Trials: Current barriers and facilitators to implementation in funders and clinical trials units |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided and hosting for this collaboration |
| Collaborator Contribution | Various collaborative research efforts in the field of SWATS including: 1. produce a decision aid/flow diagram on how to run an embedded trial to support implementation 2. enable further work with charity funders of research by outsourcing interview transcription to free up researcher time. The research team have engaged with parties as follows:Screening survey of all registered CTUs Interviews with: • CTU leads • senior trialists • trial managers • funders Workshops with: • ICTMC 2015 participants • UKTMN 2015 conference participants Webinar with: • UKTMN members |
| Impact | none to date |
| Start Year | 2015 |
| Description | N65- Mapping current usage of Health Economic Analysis Plans (HEAPs) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided. Coapplicants within the Network |
| Collaborator Contribution | The use of statistical analysis plans (SAPs), drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of randomised controlled trials (RCTs). However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance, and there is a fundamental question over whether they add value to the trial process at all. In the collective experience of members of the Health Economic Resource Use and Costs Working Group, there is currently substantial variation in the structure, format and content of HEAPs, and no real agreement on either their purpose or appropriate methods of oversight. Clarity on the need for, and appropriate usage of, HEAPs would be advantageous. We therefore propose to hold a workshop on HEAPs for about 50 attendees in Bristol, with three key aims. First, we plan to review the limited number of currently available guidelines addressing aspects of HEAPs. We also intend to collate information about the current usage of HEAPs in terms of their structure, content and purpose. Finally, we aim to provide a forum in which health economists and other interested parties engaged in applied economic evaluations can open a dialogue on appropriate methods of standardisation with a view to creating guidance in future work. |
| Impact | ongoing |
| Start Year | 2015 |
| Description | N65- Mapping current usage of Health Economic Analysis Plans (HEAPs) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided. Coapplicants within the Network |
| Collaborator Contribution | The use of statistical analysis plans (SAPs), drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of randomised controlled trials (RCTs). However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance, and there is a fundamental question over whether they add value to the trial process at all. In the collective experience of members of the Health Economic Resource Use and Costs Working Group, there is currently substantial variation in the structure, format and content of HEAPs, and no real agreement on either their purpose or appropriate methods of oversight. Clarity on the need for, and appropriate usage of, HEAPs would be advantageous. We therefore propose to hold a workshop on HEAPs for about 50 attendees in Bristol, with three key aims. First, we plan to review the limited number of currently available guidelines addressing aspects of HEAPs. We also intend to collate information about the current usage of HEAPs in terms of their structure, content and purpose. Finally, we aim to provide a forum in which health economists and other interested parties engaged in applied economic evaluations can open a dialogue on appropriate methods of standardisation with a view to creating guidance in future work. |
| Impact | ongoing |
| Start Year | 2015 |
| Description | N65- Mapping current usage of Health Economic Analysis Plans (HEAPs) |
| Organisation | University of Oxford |
| Department | Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided. Coapplicants within the Network |
| Collaborator Contribution | The use of statistical analysis plans (SAPs), drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of randomised controlled trials (RCTs). However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance, and there is a fundamental question over whether they add value to the trial process at all. In the collective experience of members of the Health Economic Resource Use and Costs Working Group, there is currently substantial variation in the structure, format and content of HEAPs, and no real agreement on either their purpose or appropriate methods of oversight. Clarity on the need for, and appropriate usage of, HEAPs would be advantageous. We therefore propose to hold a workshop on HEAPs for about 50 attendees in Bristol, with three key aims. First, we plan to review the limited number of currently available guidelines addressing aspects of HEAPs. We also intend to collate information about the current usage of HEAPs in terms of their structure, content and purpose. Finally, we aim to provide a forum in which health economists and other interested parties engaged in applied economic evaluations can open a dialogue on appropriate methods of standardisation with a view to creating guidance in future work. |
| Impact | ongoing |
| Start Year | 2015 |
| Description | N66- Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for stages 2- 4 of project. Coapplicants include Network members |
| Collaborator Contribution | The aim of this project is to develop a PPI intervention aimed at improving recruitment and/or retention in surgical trials. The project will consist of 4 stages: (1) Mapping current PPI practice in UK surgical trials through a survey and analysis of National Research Ethics Service data; (2) Focus groups with key stakeholders (surgical trial investigators, administrators, PPI co-ordinators and patients or members of the public involved in surgical trials) to explore the needs and challenges associated with PPI in surgical trials, perceived barriers to effective recruitment and retention in surgical trials, possible components of a PPI intervention, and participants' views about PPI impact on recruitment and retention in surgical trials; (3) A survey of stakeholders' views on the possible components of the PPI intervention and the importance of the identified barriers to recruitment and retention; (4) A consensus workshop with a purposive sample of stakeholders to determine the most suitable PPI intervention for implementation and evaluation. |
| Impact | none to date |
| Start Year | 2016 |
| Description | N66- Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials |
| Organisation | University of Aberdeen |
| Department | Health Services Research Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for stages 2- 4 of project. Coapplicants include Network members |
| Collaborator Contribution | The aim of this project is to develop a PPI intervention aimed at improving recruitment and/or retention in surgical trials. The project will consist of 4 stages: (1) Mapping current PPI practice in UK surgical trials through a survey and analysis of National Research Ethics Service data; (2) Focus groups with key stakeholders (surgical trial investigators, administrators, PPI co-ordinators and patients or members of the public involved in surgical trials) to explore the needs and challenges associated with PPI in surgical trials, perceived barriers to effective recruitment and retention in surgical trials, possible components of a PPI intervention, and participants' views about PPI impact on recruitment and retention in surgical trials; (3) A survey of stakeholders' views on the possible components of the PPI intervention and the importance of the identified barriers to recruitment and retention; (4) A consensus workshop with a purposive sample of stakeholders to determine the most suitable PPI intervention for implementation and evaluation. |
| Impact | none to date |
| Start Year | 2016 |
| Description | N66- Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials |
| Organisation | University of Oxford |
| Department | Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for stages 2- 4 of project. Coapplicants include Network members |
| Collaborator Contribution | The aim of this project is to develop a PPI intervention aimed at improving recruitment and/or retention in surgical trials. The project will consist of 4 stages: (1) Mapping current PPI practice in UK surgical trials through a survey and analysis of National Research Ethics Service data; (2) Focus groups with key stakeholders (surgical trial investigators, administrators, PPI co-ordinators and patients or members of the public involved in surgical trials) to explore the needs and challenges associated with PPI in surgical trials, perceived barriers to effective recruitment and retention in surgical trials, possible components of a PPI intervention, and participants' views about PPI impact on recruitment and retention in surgical trials; (3) A survey of stakeholders' views on the possible components of the PPI intervention and the importance of the identified barriers to recruitment and retention; (4) A consensus workshop with a purposive sample of stakeholders to determine the most suitable PPI intervention for implementation and evaluation. |
| Impact | none to date |
| Start Year | 2016 |
| Description | N67- Development of an interactive website for outcome reporting bias research |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- project includes Network members as coapplicants |
| Collaborator Contribution | This project aims to develop an interactive website such that the workshop materials and research tools developed to address the problem of ORB are widely accessible in a format that can be used by non-methodologists. In addition we wish to use the website as resource tool to change the behaviour of researchers undertaking publicly-funded clinical trials by disseminating the lessons learnt from the above research and to provide a guideline checklist of how to avoid this form of bias in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N67- Development of an interactive website for outcome reporting bias research |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- project includes Network members as coapplicants |
| Collaborator Contribution | This project aims to develop an interactive website such that the workshop materials and research tools developed to address the problem of ORB are widely accessible in a format that can be used by non-methodologists. In addition we wish to use the website as resource tool to change the behaviour of researchers undertaking publicly-funded clinical trials by disseminating the lessons learnt from the above research and to provide a guideline checklist of how to avoid this form of bias in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N67- Development of an interactive website for outcome reporting bias research |
| Organisation | University of Warwick |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- project includes Network members as coapplicants |
| Collaborator Contribution | This project aims to develop an interactive website such that the workshop materials and research tools developed to address the problem of ORB are widely accessible in a format that can be used by non-methodologists. In addition we wish to use the website as resource tool to change the behaviour of researchers undertaking publicly-funded clinical trials by disseminating the lessons learnt from the above research and to provide a guideline checklist of how to avoid this form of bias in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N68- Clinical trials in small populations: methodological challenges and solutions |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding. Coapplicants are Network members |
| Collaborator Contribution | Funding for two workshops. The proposed two-day meeting will bring together methodologists, applied statisticians, patient representatives and regulators to disseminate state-of-the-art methods and set priorities for methodological research in trials in small populations. The meeting will be structured so that Day 1 will be open to a selected audience of applied statisticians who will participate in an interactive workshop comprising discussions motivated by case studies of trials, worked examples of relevant methods and software demonstrations. Attendance at Day 2 will be open to all and will comprise invited talks covering statistical and practical issues related to the design, conduct and analysis of trials in small populations. |
| Impact | One workshop already run to date |
| Start Year | 2015 |
| Description | N68- Clinical trials in small populations: methodological challenges and solutions |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding. Coapplicants are Network members |
| Collaborator Contribution | Funding for two workshops. The proposed two-day meeting will bring together methodologists, applied statisticians, patient representatives and regulators to disseminate state-of-the-art methods and set priorities for methodological research in trials in small populations. The meeting will be structured so that Day 1 will be open to a selected audience of applied statisticians who will participate in an interactive workshop comprising discussions motivated by case studies of trials, worked examples of relevant methods and software demonstrations. Attendance at Day 2 will be open to all and will comprise invited talks covering statistical and practical issues related to the design, conduct and analysis of trials in small populations. |
| Impact | One workshop already run to date |
| Start Year | 2015 |
| Description | N68- Clinical trials in small populations: methodological challenges and solutions |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding. Coapplicants are Network members |
| Collaborator Contribution | Funding for two workshops. The proposed two-day meeting will bring together methodologists, applied statisticians, patient representatives and regulators to disseminate state-of-the-art methods and set priorities for methodological research in trials in small populations. The meeting will be structured so that Day 1 will be open to a selected audience of applied statisticians who will participate in an interactive workshop comprising discussions motivated by case studies of trials, worked examples of relevant methods and software demonstrations. Attendance at Day 2 will be open to all and will comprise invited talks covering statistical and practical issues related to the design, conduct and analysis of trials in small populations. |
| Impact | One workshop already run to date |
| Start Year | 2015 |
| Description | N68- Clinical trials in small populations: methodological challenges and solutions |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding. Coapplicants are Network members |
| Collaborator Contribution | Funding for two workshops. The proposed two-day meeting will bring together methodologists, applied statisticians, patient representatives and regulators to disseminate state-of-the-art methods and set priorities for methodological research in trials in small populations. The meeting will be structured so that Day 1 will be open to a selected audience of applied statisticians who will participate in an interactive workshop comprising discussions motivated by case studies of trials, worked examples of relevant methods and software demonstrations. Attendance at Day 2 will be open to all and will comprise invited talks covering statistical and practical issues related to the design, conduct and analysis of trials in small populations. |
| Impact | One workshop already run to date |
| Start Year | 2015 |
| Description | N68- Clinical trials in small populations: methodological challenges and solutions |
| Organisation | University of Warwick |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding. Coapplicants are Network members |
| Collaborator Contribution | Funding for two workshops. The proposed two-day meeting will bring together methodologists, applied statisticians, patient representatives and regulators to disseminate state-of-the-art methods and set priorities for methodological research in trials in small populations. The meeting will be structured so that Day 1 will be open to a selected audience of applied statisticians who will participate in an interactive workshop comprising discussions motivated by case studies of trials, worked examples of relevant methods and software demonstrations. Attendance at Day 2 will be open to all and will comprise invited talks covering statistical and practical issues related to the design, conduct and analysis of trials in small populations. |
| Impact | One workshop already run to date |
| Start Year | 2015 |
| Description | N73- Exploring design and use of incentives for recruitment and retention in clinical trials: a workshop and a review. |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- coapplicants include Network members |
| Collaborator Contribution | The key aim of this project is to describe the scope of incentives in trials, to explore their design and use and describe their potential effects on trial outcomes. We will do so by organising two workshops that will consider a conceptual framework on the design and use of incentives for recruitment and retention using theories of behavioural change and ethics. We will also assess acceptability of incentives to stakeholders. We will then disseminate our conceptual framework in an open access journal, on a website and provide resources for the clinical trials community, including guidance on design and use of incentives in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N73- Exploring design and use of incentives for recruitment and retention in clinical trials: a workshop and a review. |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- coapplicants include Network members |
| Collaborator Contribution | The key aim of this project is to describe the scope of incentives in trials, to explore their design and use and describe their potential effects on trial outcomes. We will do so by organising two workshops that will consider a conceptual framework on the design and use of incentives for recruitment and retention using theories of behavioural change and ethics. We will also assess acceptability of incentives to stakeholders. We will then disseminate our conceptual framework in an open access journal, on a website and provide resources for the clinical trials community, including guidance on design and use of incentives in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N73- Exploring design and use of incentives for recruitment and retention in clinical trials: a workshop and a review. |
| Organisation | Ulster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- coapplicants include Network members |
| Collaborator Contribution | The key aim of this project is to describe the scope of incentives in trials, to explore their design and use and describe their potential effects on trial outcomes. We will do so by organising two workshops that will consider a conceptual framework on the design and use of incentives for recruitment and retention using theories of behavioural change and ethics. We will also assess acceptability of incentives to stakeholders. We will then disseminate our conceptual framework in an open access journal, on a website and provide resources for the clinical trials community, including guidance on design and use of incentives in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N73- Exploring design and use of incentives for recruitment and retention in clinical trials: a workshop and a review. |
| Organisation | University of Aberdeen |
| Department | Health Services Research Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- coapplicants include Network members |
| Collaborator Contribution | The key aim of this project is to describe the scope of incentives in trials, to explore their design and use and describe their potential effects on trial outcomes. We will do so by organising two workshops that will consider a conceptual framework on the design and use of incentives for recruitment and retention using theories of behavioural change and ethics. We will also assess acceptability of incentives to stakeholders. We will then disseminate our conceptual framework in an open access journal, on a website and provide resources for the clinical trials community, including guidance on design and use of incentives in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N73- Exploring design and use of incentives for recruitment and retention in clinical trials: a workshop and a review. |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided- coapplicants include Network members |
| Collaborator Contribution | The key aim of this project is to describe the scope of incentives in trials, to explore their design and use and describe their potential effects on trial outcomes. We will do so by organising two workshops that will consider a conceptual framework on the design and use of incentives for recruitment and retention using theories of behavioural change and ethics. We will also assess acceptability of incentives to stakeholders. We will then disseminate our conceptual framework in an open access journal, on a website and provide resources for the clinical trials community, including guidance on design and use of incentives in trials. |
| Impact | none to date |
| Start Year | 2015 |
| Description | N76- Online tool for guidance on designing biomarker-guided randomised controlled trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided. Coapplicants include Network members |
| Collaborator Contribution | we propose to develop a website using interactive visualisation to provide a user-friendly and easily accessible resource for informing those embarking on a biomarker-guided trial on the most optimal design. The website will initially mirror the findings of the systematic review, but in a much more accessible format, and will subsequently be extended to provide a truly interactive tool allowing searches for the optimal design in a given setting as well as sample size estimates. The idea for the project has stemmed from feedback from attendees of conferences and meetings where the systematic review work was presented, which suggested a real need for information on the different trial designs to be available in an easily accessible and user-friendly format |
| Impact | none to date |
| Start Year | 2016 |
| Description | N76- Online tool for guidance on designing biomarker-guided randomised controlled trials |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided. Coapplicants include Network members |
| Collaborator Contribution | we propose to develop a website using interactive visualisation to provide a user-friendly and easily accessible resource for informing those embarking on a biomarker-guided trial on the most optimal design. The website will initially mirror the findings of the systematic review, but in a much more accessible format, and will subsequently be extended to provide a truly interactive tool allowing searches for the optimal design in a given setting as well as sample size estimates. The idea for the project has stemmed from feedback from attendees of conferences and meetings where the systematic review work was presented, which suggested a real need for information on the different trial designs to be available in an easily accessible and user-friendly format |
| Impact | none to date |
| Start Year | 2016 |
| Description | N78 -Development of user-friendly web-based software for conducting Bayesian Phase I dose-escalation studies |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The Network has provided project funding to develop this researc |
| Collaborator Contribution | Phase I dose-escalation studies are essential to determine the safe dosing range of a novel compound. Despite the poor operating characteristics of algorithmic methods such as the 3+3 design, superior model-based strategies are still rarely used. One of the main reasons why these Bayesian adaptive designs are not implemented is the lack of easy-to-use and accessible software. This project seeks to develop software for model-based doseescalation studies. A standalone, fully documented system will be developed that allows investigators to plan, explore and conduct such studies without the need for technical expertise in the underlying methods. To ensure that the software is fit for purpose, it will be rigorously tested by different user groups (clinical experts, principal investigators, trial managers, statisticians) and training workshops will be held to facilitate uptake |
| Impact | outputs due 2017 |
| Start Year | 2016 |
| Description | N79 Efficient sample schemes for estimation of value of information of future research |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The Network has provided funding for this project |
| Collaborator Contribution | Cost-effectiveness models are used in health economic decision making to compare the costs and effects of competing strategies for the management of disease. These decision recommendations are uncertain due to limitations in the available evidence. Value of information calculations measure the expected improvement in our decision recommendations, on the monetary scale, if we reduce (EVSI) or eliminate (EVPPI) uncertainty by gathering further evidence. EVPPI and EVSI can therefore be used to guide research funding decisions, and inform trial design. However, as EVPPI and EVSI involve the expectation of a maximum of a conditional expectation, 2-level nested Monte Carlo simulation and sometimes additional Markov chain Monte Carlo simulation is necessary. This is very computationally intensive and often impractical. This project aims to assess the potential of efficient sampling techniques to reduce the computational burden of EVPPI and EVSI. Simulations where the decision doesn't change contribute nothing to EVPPI and EVSI. One approach is therefore to use importance sampling and stratified sampling schemes to sample more frequently in the space where decisions change, with appropriate re-weighting. We will develop importance sampling methods for use in the computation of EVPPI and EVSI, and explore their performance on a range of examples. Another approach is to use a method from pricing financial derivatives, such as simple call and put options, which also rely on the estimation a maximum of several processes. We will explore whether numerical techniques developed in this area of mathematical finance, in particular for non-Normal underlying stocks, can be applied to the estimation of the EVPPI and EVSI. We will meet with technical experts in simulation methodology and pricing financial derivatives, to explore how these techniques can be applied to EVPPI and EVSI. We will then apply the methodology to some illustrative examples, and present the work in a focused meeting. |
| Impact | na |
| Start Year | 2016 |
| Description | N83 Impact Award: Improving the design and analysis of trials for efficacy and mechanisms evaluation: workshop and training days |
| Organisation | King's College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Following well attended EME Workshops and Training days the organisers believe there is demand from statisticians in trials units and from trialists for more training in EME methods. The workshops involve presentation of ideas and group discussion, while the training day involve briefer presentation of ideas and computer practicals in Stata. Both events were well attended (approx. 60 and 30 attendees respectively) and well received by the attendees. Therefore we conclude that there is |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N83 Impact Award: Improving the design and analysis of trials for efficacy and mechanisms evaluation: workshop and training days |
| Organisation | Lancaster University |
| Department | Department of Mathematics and Statistics |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Following well attended EME Workshops and Training days the organisers believe there is demand from statisticians in trials units and from trialists for more training in EME methods. The workshops involve presentation of ideas and group discussion, while the training day involve briefer presentation of ideas and computer practicals in Stata. Both events were well attended (approx. 60 and 30 attendees respectively) and well received by the attendees. Therefore we conclude that there is |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N83 Impact Award: Improving the design and analysis of trials for efficacy and mechanisms evaluation: workshop and training days |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Following well attended EME Workshops and Training days the organisers believe there is demand from statisticians in trials units and from trialists for more training in EME methods. The workshops involve presentation of ideas and group discussion, while the training day involve briefer presentation of ideas and computer practicals in Stata. Both events were well attended (approx. 60 and 30 attendees respectively) and well received by the attendees. Therefore we conclude that there is |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N83- Improving the design and analysis of trials for efficacy and mechanisms evaluation: workshop and training days. |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for this research |
| Collaborator Contribution | The MRC/NIHR EME Programme funds clinical studies testing both if an intervention works in a defined population of patients, and providing opportunity to understand disease or treatment mechanisms. However, there remain significant methodological challenges in performing mechanistic evaluations and accounting for departures from randomised allocations in order to assess efficacy (rather than effectiveness). Uptake of the available methods has been limited, though increasing in popularity. Our aim is to organise a workshop and training day centred on how to use causal methods to understand mechanisms of action for treatments. The workshop will invite experts in the area to identify important topics and challenges and to discuss ways in which these methods might be utilised more in clinical research studies. A representative from the EME board will give an overview of the scheme, and how they consider mechanisms evaluation when evaluating applications. The results of this workshop will inform a training day approximately six months later for researchers who are interested in incorporating mechanistic methods into their clinical studies. Workshop We will hold a one-day workshop in Lancaster in 2016. We will invite key stakeholders from the area, including representatives from the EME board, and discuss issues and suitable methods for different types of intervention: pharmaceutical, psychotherapy, behaviour change, and surgery. The outcomes of the workshop will be used to develop a training day for researchers in clinical studies. Training day. Six months after the one day workshop we will hold a one day training workshop, also provisionally in Lancaster. This workshop will be aimed at clinicians and methodologists new to the area and who are in the process of designing mechanistic studies, and intending to apply for EME funding. We plan to use organisations such as the NIHR Clinical Research Network, the RDS, and EME to advertise to find applicants |
| Impact | na |
| Start Year | 2016 |
| Description | N84- What might a Global Health Trials Methodology Research Agenda look like? |
| Organisation | Liverpool School of Tropical Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network has provided funding |
| Collaborator Contribution | Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. A previous study identified the methodology research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. In the 2013 World Health Report, there was an unequivocal statement that unless low- and middle-income countries (LMICs) become the generators and not the recipients of research data, there will never be any real improvements in public health outcomes in these most underserved regions of the world. This lack of data is the result of too few studies being conducted in low-income settings. Therefore undertaking methodology research is required to identify the gaps and issues in order to optimise design, ease and quality with the aim of making research relevant and accessible to health care workers in these regions. The MRC HTMR Network has established a portfolio of methodology research of relevance to the UK trials community. It is important, and timely, to establish the relevance of this work to LMIC settings, but also to identify gaps where further research would benefit clinical trials in LMICs. The aim of this project is to identify trials methodology research priorities in LMICs. We predict each region can gain valuable lessons from the other. |
| Impact | na |
| Start Year | 2016 |
| Description | N84- What might a Global Health Trials Methodology Research Agenda look like? |
| Organisation | The Global Health Network |
| Country | Global |
| Sector | Charity/Non Profit |
| PI Contribution | Network has provided funding |
| Collaborator Contribution | Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. A previous study identified the methodology research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. In the 2013 World Health Report, there was an unequivocal statement that unless low- and middle-income countries (LMICs) become the generators and not the recipients of research data, there will never be any real improvements in public health outcomes in these most underserved regions of the world. This lack of data is the result of too few studies being conducted in low-income settings. Therefore undertaking methodology research is required to identify the gaps and issues in order to optimise design, ease and quality with the aim of making research relevant and accessible to health care workers in these regions. The MRC HTMR Network has established a portfolio of methodology research of relevance to the UK trials community. It is important, and timely, to establish the relevance of this work to LMIC settings, but also to identify gaps where further research would benefit clinical trials in LMICs. The aim of this project is to identify trials methodology research priorities in LMICs. We predict each region can gain valuable lessons from the other. |
| Impact | na |
| Start Year | 2016 |
| Description | N84- What might a Global Health Trials Methodology Research Agenda look like? |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network has provided funding |
| Collaborator Contribution | Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. A previous study identified the methodology research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. In the 2013 World Health Report, there was an unequivocal statement that unless low- and middle-income countries (LMICs) become the generators and not the recipients of research data, there will never be any real improvements in public health outcomes in these most underserved regions of the world. This lack of data is the result of too few studies being conducted in low-income settings. Therefore undertaking methodology research is required to identify the gaps and issues in order to optimise design, ease and quality with the aim of making research relevant and accessible to health care workers in these regions. The MRC HTMR Network has established a portfolio of methodology research of relevance to the UK trials community. It is important, and timely, to establish the relevance of this work to LMIC settings, but also to identify gaps where further research would benefit clinical trials in LMICs. The aim of this project is to identify trials methodology research priorities in LMICs. We predict each region can gain valuable lessons from the other. |
| Impact | na |
| Start Year | 2016 |
| Description | N84- What might a Global Health Trials Methodology Research Agenda look like? |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network has provided funding |
| Collaborator Contribution | Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. A previous study identified the methodology research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. In the 2013 World Health Report, there was an unequivocal statement that unless low- and middle-income countries (LMICs) become the generators and not the recipients of research data, there will never be any real improvements in public health outcomes in these most underserved regions of the world. This lack of data is the result of too few studies being conducted in low-income settings. Therefore undertaking methodology research is required to identify the gaps and issues in order to optimise design, ease and quality with the aim of making research relevant and accessible to health care workers in these regions. The MRC HTMR Network has established a portfolio of methodology research of relevance to the UK trials community. It is important, and timely, to establish the relevance of this work to LMIC settings, but also to identify gaps where further research would benefit clinical trials in LMICs. The aim of this project is to identify trials methodology research priorities in LMICs. We predict each region can gain valuable lessons from the other. |
| Impact | na |
| Start Year | 2016 |
| Description | N84- What might a Global Health Trials Methodology Research Agenda look like? |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network has provided funding |
| Collaborator Contribution | Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. A previous study identified the methodology research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. In the 2013 World Health Report, there was an unequivocal statement that unless low- and middle-income countries (LMICs) become the generators and not the recipients of research data, there will never be any real improvements in public health outcomes in these most underserved regions of the world. This lack of data is the result of too few studies being conducted in low-income settings. Therefore undertaking methodology research is required to identify the gaps and issues in order to optimise design, ease and quality with the aim of making research relevant and accessible to health care workers in these regions. The MRC HTMR Network has established a portfolio of methodology research of relevance to the UK trials community. It is important, and timely, to establish the relevance of this work to LMIC settings, but also to identify gaps where further research would benefit clinical trials in LMICs. The aim of this project is to identify trials methodology research priorities in LMICs. We predict each region can gain valuable lessons from the other. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | McMaster University |
| Country | Canada |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Nottingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Southampton |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N85- Guidance to optimise pilot study design and conduct: A joint HTMR and NIHR HTA 'Research on Research' proposal |
| Organisation | University of Stirling |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | There are a growing number of studies described as pilot or feasibility studies, which are undertaken to inform a main randomised trial. The NIHR has provided definitions which are helpful, however, it can be very unclear when to undertake feasibility work, or a pilot RCT and whether an internal or external pilot is the best choice of design. The confusion means that many pilot and feasibility studies are poorly designed, conducted, and reported and terminology remains inconsistent. In recent years there have been several initiatives in these areas, including a workshop on internal pilot studies funded by the HTMR in 2014 (Avery, Blazeby/Williamson), a programme of work on the definition and reporting of external pilot and feasibility studies including development of a CONSORT extension guideline (Eldridge/Thabane/Lancaster/Campbell/Hopewell/Coleman/Bond), and qualitative research in pilot and feasibility studies (Hoddinott/O'Cathian). However, there remains some key unanswered questions in this field. In particular, there has been no work focusing on when researchers should use internal or external randomised pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding. We plan a piece of literature work (analyses of NIHR HTA funded main trials with an internal pilot study to explore their decision making in relation to progression criteria) and a two-day event. The combined activities will build on our individual expertise and lead to guidance documents to be published, material to be made available on the web and further meetings with clinical trialists and funding bodies to widely implement the recommendations for when to conduct each type of pilot and/or feasibility study design. |
| Impact | na |
| Start Year | 2016 |
| Description | N86 Impact award Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The aim of the proposed impact/dissemination work is to develop short 'digital' (video and written) stories targeted at surgical clinicians to enhance clinician engagement in trials and discuss these with clinicians active in trials research. The original project was a qualitative study to inform a stakeholder workshop. This included 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) semi-structured interviews with key clinicians and trials units staff. Interviewees and meetings were purposively sampled across a range of TRCs, geographical locations and surgical areas. Thematic analysis of transcripts was used to identify key themes in the data relating to the barriers and facilitators to successful trial conduct by TRCs. Findings will inform a meeting with stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. The proposed impact/dissemination project will use existing data and strategies identified in the stakeholder workshop to develop short digital stories using a method of Integrated Participant Storytelling. Stories will then be discussed with clinicians in a focus group. Proposed impact/dissemination - Several short digital stories (video and paper-based) which share strategies to enhance clinician engagement with trials. |
| Impact | No impact yet |
| Start Year | 2019 |
| Description | N86 Impact award Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Bristol |
| Department | School of Social and Community Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The aim of the proposed impact/dissemination work is to develop short 'digital' (video and written) stories targeted at surgical clinicians to enhance clinician engagement in trials and discuss these with clinicians active in trials research. The original project was a qualitative study to inform a stakeholder workshop. This included 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) semi-structured interviews with key clinicians and trials units staff. Interviewees and meetings were purposively sampled across a range of TRCs, geographical locations and surgical areas. Thematic analysis of transcripts was used to identify key themes in the data relating to the barriers and facilitators to successful trial conduct by TRCs. Findings will inform a meeting with stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. The proposed impact/dissemination project will use existing data and strategies identified in the stakeholder workshop to develop short digital stories using a method of Integrated Participant Storytelling. Stories will then be discussed with clinicians in a focus group. Proposed impact/dissemination - Several short digital stories (video and paper-based) which share strategies to enhance clinician engagement with trials. |
| Impact | No impact yet |
| Start Year | 2019 |
| Description | N86 Impact award Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The aim of the proposed impact/dissemination work is to develop short 'digital' (video and written) stories targeted at surgical clinicians to enhance clinician engagement in trials and discuss these with clinicians active in trials research. The original project was a qualitative study to inform a stakeholder workshop. This included 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) semi-structured interviews with key clinicians and trials units staff. Interviewees and meetings were purposively sampled across a range of TRCs, geographical locations and surgical areas. Thematic analysis of transcripts was used to identify key themes in the data relating to the barriers and facilitators to successful trial conduct by TRCs. Findings will inform a meeting with stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. The proposed impact/dissemination project will use existing data and strategies identified in the stakeholder workshop to develop short digital stories using a method of Integrated Participant Storytelling. Stories will then be discussed with clinicians in a focus group. Proposed impact/dissemination - Several short digital stories (video and paper-based) which share strategies to enhance clinician engagement with trials. |
| Impact | No impact yet |
| Start Year | 2019 |
| Description | N86 Impact award Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The aim of the proposed impact/dissemination work is to develop short 'digital' (video and written) stories targeted at surgical clinicians to enhance clinician engagement in trials and discuss these with clinicians active in trials research. The original project was a qualitative study to inform a stakeholder workshop. This included 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) semi-structured interviews with key clinicians and trials units staff. Interviewees and meetings were purposively sampled across a range of TRCs, geographical locations and surgical areas. Thematic analysis of transcripts was used to identify key themes in the data relating to the barriers and facilitators to successful trial conduct by TRCs. Findings will inform a meeting with stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. The proposed impact/dissemination project will use existing data and strategies identified in the stakeholder workshop to develop short digital stories using a method of Integrated Participant Storytelling. Stories will then be discussed with clinicians in a focus group. Proposed impact/dissemination - Several short digital stories (video and paper-based) which share strategies to enhance clinician engagement with trials. |
| Impact | No impact yet |
| Start Year | 2019 |
| Description | N86- Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Background: Many trials fail to recruit successfully or complete on time and one contributory factor is clinician engagement with trials. This has been a notable issue in surgical trials, with preferences for interventions common and a lack of research-active senior surgeons. Recently, several initiatives are changing this. The Royal College of Surgeons have invested in Surgical Trials Centres and Speciality Leads to promote trial participation. Twenty-four surgical Trainee Research Collaboratives (TRCs) have also been established across the UK, which allow trainees to become involved in trials within a large collaborative research group. These TRCs have completed several surgical trials, and have recently spread to anaesthetics. Benefits include improved trial recruitment and a research-active consultant workforce. The reasons for the TRCs' success are unknown but understanding them is key to potential wider translation to other clinical areas. Aims: This project aims to 1) identify the key elements leading to successful trials conducted by surgical TRCs and 2) synthesise these findings to develop strategies to enhance clinician engagement in trials across other clinical specialties, including clinician training. Methods: A qualitative research study to inform a one day trialist stakeholders workshop. The research will include: 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) in-depth semi-structured interviews with key clinicians and trials units staff. Trials and linked personnel will be purposefully sampled across three geographical locations to include a variety of surgical specialties, clinicians and TRCs. Meetings and interviews will be audio-recorded and transcribed. Thematic analysis of transcripts will use the constant comparative method. Outputs: Results will be synthesised and reviewed by co-applicants. These will inform a meeting with key trialists and clinical stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. Peer-review publications and presentations. |
| Impact | n |
| Start Year | 2016 |
| Description | N86- Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Background: Many trials fail to recruit successfully or complete on time and one contributory factor is clinician engagement with trials. This has been a notable issue in surgical trials, with preferences for interventions common and a lack of research-active senior surgeons. Recently, several initiatives are changing this. The Royal College of Surgeons have invested in Surgical Trials Centres and Speciality Leads to promote trial participation. Twenty-four surgical Trainee Research Collaboratives (TRCs) have also been established across the UK, which allow trainees to become involved in trials within a large collaborative research group. These TRCs have completed several surgical trials, and have recently spread to anaesthetics. Benefits include improved trial recruitment and a research-active consultant workforce. The reasons for the TRCs' success are unknown but understanding them is key to potential wider translation to other clinical areas. Aims: This project aims to 1) identify the key elements leading to successful trials conducted by surgical TRCs and 2) synthesise these findings to develop strategies to enhance clinician engagement in trials across other clinical specialties, including clinician training. Methods: A qualitative research study to inform a one day trialist stakeholders workshop. The research will include: 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) in-depth semi-structured interviews with key clinicians and trials units staff. Trials and linked personnel will be purposefully sampled across three geographical locations to include a variety of surgical specialties, clinicians and TRCs. Meetings and interviews will be audio-recorded and transcribed. Thematic analysis of transcripts will use the constant comparative method. Outputs: Results will be synthesised and reviewed by co-applicants. These will inform a meeting with key trialists and clinical stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. Peer-review publications and presentations. |
| Impact | n |
| Start Year | 2016 |
| Description | N86- Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Background: Many trials fail to recruit successfully or complete on time and one contributory factor is clinician engagement with trials. This has been a notable issue in surgical trials, with preferences for interventions common and a lack of research-active senior surgeons. Recently, several initiatives are changing this. The Royal College of Surgeons have invested in Surgical Trials Centres and Speciality Leads to promote trial participation. Twenty-four surgical Trainee Research Collaboratives (TRCs) have also been established across the UK, which allow trainees to become involved in trials within a large collaborative research group. These TRCs have completed several surgical trials, and have recently spread to anaesthetics. Benefits include improved trial recruitment and a research-active consultant workforce. The reasons for the TRCs' success are unknown but understanding them is key to potential wider translation to other clinical areas. Aims: This project aims to 1) identify the key elements leading to successful trials conducted by surgical TRCs and 2) synthesise these findings to develop strategies to enhance clinician engagement in trials across other clinical specialties, including clinician training. Methods: A qualitative research study to inform a one day trialist stakeholders workshop. The research will include: 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) in-depth semi-structured interviews with key clinicians and trials units staff. Trials and linked personnel will be purposefully sampled across three geographical locations to include a variety of surgical specialties, clinicians and TRCs. Meetings and interviews will be audio-recorded and transcribed. Thematic analysis of transcripts will use the constant comparative method. Outputs: Results will be synthesised and reviewed by co-applicants. These will inform a meeting with key trialists and clinical stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. Peer-review publications and presentations. |
| Impact | n |
| Start Year | 2016 |
| Description | N86- Developing a medical work force to design and conduct trials to improve evidence-based practice: a case study of surgical Trainee Research Collaboratives and a stakeholder workshop |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Background: Many trials fail to recruit successfully or complete on time and one contributory factor is clinician engagement with trials. This has been a notable issue in surgical trials, with preferences for interventions common and a lack of research-active senior surgeons. Recently, several initiatives are changing this. The Royal College of Surgeons have invested in Surgical Trials Centres and Speciality Leads to promote trial participation. Twenty-four surgical Trainee Research Collaboratives (TRCs) have also been established across the UK, which allow trainees to become involved in trials within a large collaborative research group. These TRCs have completed several surgical trials, and have recently spread to anaesthetics. Benefits include improved trial recruitment and a research-active consultant workforce. The reasons for the TRCs' success are unknown but understanding them is key to potential wider translation to other clinical areas. Aims: This project aims to 1) identify the key elements leading to successful trials conducted by surgical TRCs and 2) synthesise these findings to develop strategies to enhance clinician engagement in trials across other clinical specialties, including clinician training. Methods: A qualitative research study to inform a one day trialist stakeholders workshop. The research will include: 1) non-participant observation of TRC-linked surgical trials and TRC meetings, and 2) in-depth semi-structured interviews with key clinicians and trials units staff. Trials and linked personnel will be purposefully sampled across three geographical locations to include a variety of surgical specialties, clinicians and TRCs. Meetings and interviews will be audio-recorded and transcribed. Thematic analysis of transcripts will use the constant comparative method. Outputs: Results will be synthesised and reviewed by co-applicants. These will inform a meeting with key trialists and clinical stakeholders to develop strategies to enhance clinicians' engagement in trials which could subsequently be tested in other specialties and inform post-graduate clinician training. Peer-review publications and presentations. |
| Impact | n |
| Start Year | 2016 |
| Description | N87 - Advancing the integration of mixed methods in clinical trials: a two day summit |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice. |
| Impact | na |
| Start Year | 2017 |
| Description | N87 - Advancing the integration of mixed methods in clinical trials: a two day summit |
| Organisation | University of Exeter |
| Department | Medical School |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice. |
| Impact | na |
| Start Year | 2017 |
| Description | N87 - Advancing the integration of mixed methods in clinical trials: a two day summit |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice. |
| Impact | na |
| Start Year | 2017 |
| Description | N89 - Improving the efficiency of biomarker-guided trial designs by using continuous biomarker information. |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Biomarkers are increasingly being identified that have the potential to predict how well patients will respond to a treatment. The ultimate aim is to measure the biomarker in clinical practice and use the results to stratify patients, treating them differently depending on the stratum they are in. However, whilst genetic biomarkers with their typically categorical nature lend themselves easily to the idea of stratification, it is not so clear how continuous biomarkers should be used in this way. In addition, before implementing a biomarker to guide treatment in clinical practice, the effectiveness of the biomarker guided approach to treatment must be demonstrated, typically in the form of a biomarker guided trial. However, the design of such trials typically assumes dichotomisation of the biomarker, which loses substantial statistical efficiency. It is unclear how continuous biomarkers should be incorporated and at what stage of the clinical development process the biomarker information should be dichotomised. In this project we propose to review methodologies for determining how to optimally stratify patients using continuous biomarkers, both in the context of a single biomarker and where a panel of biomarkers are predictive, as well as considering at what timepoint during the biomarker's development this decision should be made. The methodologies used in the evidence base for biomarkers already recommended for clinical use will also be investigated. Based on this work we will be able to provide guidance for researchers on the most suitable approach to use. We will also aim to identify gaps in methodology that future work can address. |
| Impact | na |
| Start Year | 2017 |
| Description | N89 - Improving the efficiency of biomarker-guided trial designs by using continuous biomarker information. |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Biomarkers are increasingly being identified that have the potential to predict how well patients will respond to a treatment. The ultimate aim is to measure the biomarker in clinical practice and use the results to stratify patients, treating them differently depending on the stratum they are in. However, whilst genetic biomarkers with their typically categorical nature lend themselves easily to the idea of stratification, it is not so clear how continuous biomarkers should be used in this way. In addition, before implementing a biomarker to guide treatment in clinical practice, the effectiveness of the biomarker guided approach to treatment must be demonstrated, typically in the form of a biomarker guided trial. However, the design of such trials typically assumes dichotomisation of the biomarker, which loses substantial statistical efficiency. It is unclear how continuous biomarkers should be incorporated and at what stage of the clinical development process the biomarker information should be dichotomised. In this project we propose to review methodologies for determining how to optimally stratify patients using continuous biomarkers, both in the context of a single biomarker and where a panel of biomarkers are predictive, as well as considering at what timepoint during the biomarker's development this decision should be made. The methodologies used in the evidence base for biomarkers already recommended for clinical use will also be investigated. Based on this work we will be able to provide guidance for researchers on the most suitable approach to use. We will also aim to identify gaps in methodology that future work can address. |
| Impact | na |
| Start Year | 2017 |
| Description | N90 - Developing CONSORT guidance for adaptive clinical trials |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research. |
| Impact | na |
| Start Year | 2017 |
| Description | N90 - Developing CONSORT guidance for adaptive clinical trials |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research. |
| Impact | na |
| Start Year | 2017 |
| Description | N90 - Developing CONSORT guidance for adaptive clinical trials |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research. |
| Impact | na |
| Start Year | 2017 |
| Description | N91 - Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | Bangor University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely. |
| Impact | na |
| Start Year | 2017 |
| Description | N91 - Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely. |
| Impact | na |
| Start Year | 2017 |
| Description | N91 - Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely. |
| Impact | na |
| Start Year | 2017 |
| Description | N91 - Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely. |
| Impact | na |
| Start Year | 2017 |
| Description | N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | Bangor University |
| Department | Centre for Health Economics and Medicines Evaluation |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | N96 Covariate adjustment in randomised trials |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding. |
| Collaborator Contribution | Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N96 Covariate adjustment in randomised trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding. |
| Collaborator Contribution | Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N96 Covariate adjustment in randomised trials |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding. |
| Collaborator Contribution | Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner. |
| Impact | N/A |
| Start Year | 2017 |
| Description | N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network Provided Funding |
| Collaborator Contribution | Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner. |
| Impact | N/A |
| Start Year | 2017 |
| Description | NETSCC shared promotion and collaboration- toolkit |
| Organisation | NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Collaboration and sharing of information and resource. In 2015 we have liaised with the NETSCC to have guidance from the Network entered on to the CT Toolkit online |
| Collaborator Contribution | ongoing information sharing and promotion of events |
| Impact | Information from Network guidance pack now included in the CT TOOLKIT http://www.ct-toolkit.ac.uk/ |
| Start Year | 2009 |
| Description | Outcomes Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Outcomes Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Outcomes Working Group has six main areas within its scope: core outcome sets, methodology to assess the reliability and robustness of new instruments, surrogate outcome measures, harms, the reporting of outcomes and raising awareness of ordinal outcomes and promoting their correct use. Future objectives- Future plans for this Working Group include • the completion of a systematic review of published core outcome sets (COS) • the population, maintenance and enhancement of the COMET (Core Outcome Measures in Effectiveness Trials) database • evaluation of the uptake of COS (including in electronic patient records) and • research into methods for developing and implementing COS. Members of the Working Group who are part of the COMET Initiative are working with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) group to advise COS developers on how to choose measurement instruments for outcomes in COS. Other activities include research into how feasibility studies and qualitative research can inform outcome measurement, and best practices for incorporating Patient Reported Outcomes into clinical trials. |
| Impact | various meetings and telephone call discussion |
| Start Year | 2010 |
| Description | PhD Student - R25 Record-keeping in patients with inflammatory bowel disease (IBD) within electronic patient record systems: Current practice and motivations for collecting structured data |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD - R25 - Record-keeping in patients with inflammatory bowel disease (IBD) within electronic patient record systems: Current practice and motivations for collecting structured data. Violeta Razanskaite. The Network formally advertised, processed, and recruited PhD students in 2014, 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | Funded PhD studentship |
| Impact | No impact yet. |
| Start Year | 2017 |
| Description | PhD Student - R8 Developing a modular resource-use questionnaire for use in RCTs |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD student R8 - Bristol Kirsty Garfield. The Network formally advertised, processed, and recruited PhD students in 2014, 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | Ongoing PhD Studentship |
| Impact | no impact yet |
| Start Year | 2017 |
| Description | PhD Student - R9 Exploring patient perspectives of recruitment in randomised controlled trials |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD Student - Exploring patient perspectives of recruitment in randomised controlled trials Nicola Farrar. The Network formally advertised, processed, and recruited PhD students in 2014, 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | Funded PhD studentship |
| Impact | No impact yet. |
| Start Year | 2017 |
| Description | PhD Student P15- Participation in clinical trials: analysis of organisational and site team factors that impact on site performance |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of t PhD Student P15- Participation in clinical trials: analysis of organisational and site team factors that impact on site performance. Rachael Watson The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref P15 |
| Impact | Ongoing PhD studentship |
| Start Year | 2014 |
| Description | PhD Student R12 Can routine healthcare data be used to efficiently and reliably follow-up participants in renal trials: analyses using linked data form 2 large renal trials |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | PhD Student R12 Charlie Harper Can routine healthcare data be used to efficiently and reliably follow-up participants in renal trials: analyses using linked data form 2 large renal trials. The Network formally advertised, processed, and recruited PhD students in 2014, 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | Funded PhD Student |
| Impact | No impact yet |
| Start Year | 2017 |
| Description | PhD Student R19 Evidence synthesis for biomarker validity to inform biomarker-stratified trials. |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD R19 Student Evidence synthesis for biomarker validity to inform biomarker-stratified trials. Danielle Johnson The Network formally advertised, processed, and recruited PhD students in 2014, 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | Funded PhD studentship. |
| Impact | No impact yet |
| Start Year | 2017 |
| Description | PhD Student- E1- Development of an objective measure of clinical recovery after cardiac surgery for use in RCTs |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD Student- E1- Development of an objective measure of clinical recovery after cardiac surgery for use in RCTs. Rachel Nash The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref E1 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student - R18 Design of trials for health related smart phone apps |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD student R18 - LSHTM - Design of trials for health related smart phone apps Lauren Bell. The Network formally advertised, processed, and recruited PhD students in 2014 2015 and 2016 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref R8 |
| Impact | No impacts yet |
| Start Year | 2017 |
| Description | PhD student E4-Optimising recruitment into randomised controlled trials in unplanned general surgery |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD student E4-Optimising recruitment into randomised controlled trials in unplanned general surgery. Ceri Rowlands The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref E4 |
| Impact | ongoing PhD student |
| Start Year | 2015 |
| Description | PhD student P16- Using routine data in large multicentre clinical |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student P16- Using routine data in large multicentre clinical . Graham Powell- Clinician The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref P16 |
| Impact | ongoing PhD studentship |
| Start Year | 2014 |
| Description | PhD student P21- Designing a process evaluation framework for understanding factors that impact on successful delivery of trials investigating complex critical care interventions |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student P21- Designing a process evaluation framework for understanding factors that impact on successful delivery of trials investigating complex critical care interventions. Lydia Emerson The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner University was a Hub within the Network at the time of the award and they supervise the PhD student- ref P21 |
| Impact | ongoing PhD studentship |
| Start Year | 2014 |
| Description | PhD student P27- Statistical design and analysis of cluster-randomised stepped wedge / phased implementation trials |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student P27- Statistical design and analysis of cluster-randomised stepped wedge / phased implementation trials. Jenny Thompson |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref P27 |
| Impact | Ongoing PhD studentship. |
| Start Year | 2014 |
| Description | PhD student P5- Treatment preference in paediatric randomised controlled trials |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student P5- Treatment preference in paediatric randomised controlled trials. Lucy Beasant The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref P5 |
| Impact | ongoing PhD project |
| Start Year | 2014 |
| Description | PhD student Q10-Incorporating external evidence syntheses in the analysis of a clinical trial |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD student Q10-Incorporating external evidence syntheses in the analysis of a clinical trial . Gemma Clayton. The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q10 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q25- Development and application of linked pharmacometric-pharmacoeconomic analyses in clinical drug development |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student Q25- Development and application of linked pharmacometric-pharmacoeconomic analyses in clinical drug development. Dan Hill-McManus. The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- refQ25 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q28- Cost-effective modelling for benefit-risk assessment |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding of PhD student Q28- Cost-effective modelling for benefit-risk assessment. Heather Catt The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q28 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q30- Methods to assess and improve the uptake of core outcome sets |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student Q30- Methods to assess and improve the uptake of core outcome sets. Karen Barnes# The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q30 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q34- Oxford Exploring the use of routine datasets for recruitment and follow-up in large randomised trials |
| Organisation | University of Oxford |
| Department | Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funded PhD student Q34- Oxford Exploring the use of routine datasets for recruitment and follow-up in large randomised trials. Danielle Edwards. The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q34 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q38 - Evaluating electronic data capture systems for the collection of patient reported outcomes and related data. |
| Organisation | University of Oxford |
| Department | Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Providing funding for PhD student Q38 - Evaluating electronic data capture systems for the collection of patient reported outcomes and related data. Diasmer Bloe (fees only) The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q38 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student Q7- Optimising the design and evaluation of pilot work to inform efficient randomised controlled trials in surgery |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD student Q7- Optimising the design and evaluation of pilot work to inform efficient randomised controlled trials in surgery. Katherine Fairhurst The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q7 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD student- Q29- The analysis and reporting of time to event data in randomised controlled trials: impact on evidence synthesis and cost effectiveness |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding PhD student Q29- The analysis and reporting of time to event data in randomised controlled trials: impact on evidence synthesis and cost effectiveness. Ashma Krishan The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q29 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD studentship Q1- Identifying and estimating treatment effects in cancer trials with dynamic treatment regimes |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding PhD studentship Q1- Identifying and estimating treatment effects in cancer trials with dynamic treatment regimes. Annabel Allison The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q1 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | PhD studentship- Q42 Spatial Analysis of Cluster-Randomised Trials |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Funding of PhD studentship- Q42 Spatial Analysis of Cluster-Randomised Trials. Chris Jarvis The Network formally advertised, processed, and recruited PhD students in 2014 and 2015 to support capacity building in clinical trials methodology |
| Collaborator Contribution | The partner is a Hub within the Network and they supervise the PhD student- ref Q42 |
| Impact | ongoing PhD studentship |
| Start Year | 2015 |
| Description | R1 COMET Impact Award |
| Organisation | Queen's University Belfast |
| Department | MRC All-Ireland Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network Provided Funding £9100. |
| Collaborator Contribution | This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group |
| Impact | No Impact yet. |
| Start Year | 2018 |
| Description | R1 COMET Impact Award |
| Organisation | University of Bristol |
| Department | School of Social and Community Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network Provided Funding £9100. |
| Collaborator Contribution | This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group |
| Impact | No Impact yet. |
| Start Year | 2018 |
| Description | R1 COMET Impact Award |
| Organisation | University of Liverpool |
| Department | MRC Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network Provided Funding £9100. |
| Collaborator Contribution | This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group |
| Impact | No Impact yet. |
| Start Year | 2018 |
| Description | R1 COMET Impact Award |
| Organisation | University of Oxford |
| Department | School of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | HTMR Network Provided Funding £9100. |
| Collaborator Contribution | This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group |
| Impact | No Impact yet. |
| Start Year | 2018 |
| Description | R23: A conference on maximising the value of qualitative research in randomised controlled trials (RCTs) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for conference and associated workshop . |
| Collaborator Contribution | 1. The conference was held on 21 November 2012 in Sheffield with 91 attendees from England, Scotland, Wales, Norway and The Netherlands. 97% of 38 delegates returning the evaluation form said it was an excellent or good day. Their feedback was that they felt that the talks were inspiring and they wanted further events to offer training and discussion. 2. The workshop was held on 22 November in Sheffield with 9 members: Professor Pat Hoddinott (Stirling), Professor Bridget Young (Liverpool, NW Hub), Professor Kate Thomas (Sheffield), Professor Jenny Donovan (Bristol, COnDUCT Hub), Dr Joy Adamson (York), Dr Simon Lewin (Norway), Dr Yvonne Jansen (The Netherlands), Dr Graham Moore (Cardiff) and Professor Alicia O'Cathain (Sheffield). The discussion focused on developing guidance for the use of qualitative research in feasibility studies for trials because the MRC has already funded a group to develop guidance for process evaluations. |
| Impact | Publication: PMC4659339 3. The following events arose as a direct outcome of this project: a. Professor Jenny Donovan applied for a symposium at the Society for Clinical Trials in Boston, USA. Professors Jenny Donovan, Bridget Young, Pat Hoddinott and Alicia O'Cathain and Dr Nicola Mills gave this symposium on using qualitative research to revolutionize trials on 22 May 2013 to 70 delegates from the USA and Europe. b. Professor Alicia O'Cathain accepted an invitation to join the scientific committee of the Clinical Trials Methodology Conference to be held in November 2013 in order to lead a theme on the use of qualitative research with trials. Currently, 22 abstracts have been submitted to the qualitative research theme and abstracts are being selected for oral and poster presentation. c. Professor Alicia O'Cathain accepted an invitation to join an MRC funded project writing guidance for undertaking process evaluations with trials. Professor Jenny Donovan accepted an invitation to be an external advisor on this project. d. Workshop and symposium members are writing a journal article 'O'Cathain A, Adamson J, Donovan J, Hoddinott P, Jansen Y, Lewin S, Mills N, Moore G, Thomas K, Young B. Guidance on using qualitative research in feasibility studies for randomized controlled trials.' We have approached the editor of the journal Trials who has responded positively to the proposed submission. The first draft was discussed by symposium members and a further draft is underway. Discussions are also underway for an article on developing interventions, led by Professor Pat Hoddinott. e. Professors Pat Hoddinott and Alicia O'Cathain joined the COnDUCT-II bid to strengthen the qualitative theme. This has been funded to start in 2014. |
| Start Year | 2012 |
| Description | R23: A conference on maximising the value of qualitative research in randomised controlled trials (RCTs) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for conference and associated workshop . |
| Collaborator Contribution | 1. The conference was held on 21 November 2012 in Sheffield with 91 attendees from England, Scotland, Wales, Norway and The Netherlands. 97% of 38 delegates returning the evaluation form said it was an excellent or good day. Their feedback was that they felt that the talks were inspiring and they wanted further events to offer training and discussion. 2. The workshop was held on 22 November in Sheffield with 9 members: Professor Pat Hoddinott (Stirling), Professor Bridget Young (Liverpool, NW Hub), Professor Kate Thomas (Sheffield), Professor Jenny Donovan (Bristol, COnDUCT Hub), Dr Joy Adamson (York), Dr Simon Lewin (Norway), Dr Yvonne Jansen (The Netherlands), Dr Graham Moore (Cardiff) and Professor Alicia O'Cathain (Sheffield). The discussion focused on developing guidance for the use of qualitative research in feasibility studies for trials because the MRC has already funded a group to develop guidance for process evaluations. |
| Impact | Publication: PMC4659339 3. The following events arose as a direct outcome of this project: a. Professor Jenny Donovan applied for a symposium at the Society for Clinical Trials in Boston, USA. Professors Jenny Donovan, Bridget Young, Pat Hoddinott and Alicia O'Cathain and Dr Nicola Mills gave this symposium on using qualitative research to revolutionize trials on 22 May 2013 to 70 delegates from the USA and Europe. b. Professor Alicia O'Cathain accepted an invitation to join the scientific committee of the Clinical Trials Methodology Conference to be held in November 2013 in order to lead a theme on the use of qualitative research with trials. Currently, 22 abstracts have been submitted to the qualitative research theme and abstracts are being selected for oral and poster presentation. c. Professor Alicia O'Cathain accepted an invitation to join an MRC funded project writing guidance for undertaking process evaluations with trials. Professor Jenny Donovan accepted an invitation to be an external advisor on this project. d. Workshop and symposium members are writing a journal article 'O'Cathain A, Adamson J, Donovan J, Hoddinott P, Jansen Y, Lewin S, Mills N, Moore G, Thomas K, Young B. Guidance on using qualitative research in feasibility studies for randomized controlled trials.' We have approached the editor of the journal Trials who has responded positively to the proposed submission. The first draft was discussed by symposium members and a further draft is underway. Discussions are also underway for an article on developing interventions, led by Professor Pat Hoddinott. e. Professors Pat Hoddinott and Alicia O'Cathain joined the COnDUCT-II bid to strengthen the qualitative theme. This has been funded to start in 2014. |
| Start Year | 2012 |
| Description | R23: A conference on maximising the value of qualitative research in randomised controlled trials (RCTs) |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding for conference and associated workshop . |
| Collaborator Contribution | 1. The conference was held on 21 November 2012 in Sheffield with 91 attendees from England, Scotland, Wales, Norway and The Netherlands. 97% of 38 delegates returning the evaluation form said it was an excellent or good day. Their feedback was that they felt that the talks were inspiring and they wanted further events to offer training and discussion. 2. The workshop was held on 22 November in Sheffield with 9 members: Professor Pat Hoddinott (Stirling), Professor Bridget Young (Liverpool, NW Hub), Professor Kate Thomas (Sheffield), Professor Jenny Donovan (Bristol, COnDUCT Hub), Dr Joy Adamson (York), Dr Simon Lewin (Norway), Dr Yvonne Jansen (The Netherlands), Dr Graham Moore (Cardiff) and Professor Alicia O'Cathain (Sheffield). The discussion focused on developing guidance for the use of qualitative research in feasibility studies for trials because the MRC has already funded a group to develop guidance for process evaluations. |
| Impact | Publication: PMC4659339 3. The following events arose as a direct outcome of this project: a. Professor Jenny Donovan applied for a symposium at the Society for Clinical Trials in Boston, USA. Professors Jenny Donovan, Bridget Young, Pat Hoddinott and Alicia O'Cathain and Dr Nicola Mills gave this symposium on using qualitative research to revolutionize trials on 22 May 2013 to 70 delegates from the USA and Europe. b. Professor Alicia O'Cathain accepted an invitation to join the scientific committee of the Clinical Trials Methodology Conference to be held in November 2013 in order to lead a theme on the use of qualitative research with trials. Currently, 22 abstracts have been submitted to the qualitative research theme and abstracts are being selected for oral and poster presentation. c. Professor Alicia O'Cathain accepted an invitation to join an MRC funded project writing guidance for undertaking process evaluations with trials. Professor Jenny Donovan accepted an invitation to be an external advisor on this project. d. Workshop and symposium members are writing a journal article 'O'Cathain A, Adamson J, Donovan J, Hoddinott P, Jansen Y, Lewin S, Mills N, Moore G, Thomas K, Young B. Guidance on using qualitative research in feasibility studies for randomized controlled trials.' We have approached the editor of the journal Trials who has responded positively to the proposed submission. The first draft was discussed by symposium members and a further draft is underway. Discussions are also underway for an article on developing interventions, led by Professor Pat Hoddinott. e. Professors Pat Hoddinott and Alicia O'Cathain joined the COnDUCT-II bid to strengthen the qualitative theme. This has been funded to start in 2014. |
| Start Year | 2012 |
| Description | R30- Trial Steering Committees for randomised controlled trials: updating and redeveloping guidance and terms of reference, informed by current practice and experience |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to collaborative research project |
| Collaborator Contribution | Review current guidelines, Establish new recommendations, Rebise and redevelop terms of reference. publication late 2015 and ongoing collaboration expected. |
| Impact | publication-26715378 http://www.trialsjournal.com/content/16/1/597 Development of a comprehensive Terms of Reference document. |
| Start Year | 2012 |
| Description | R30- Trial Steering Committees for randomised controlled trials: updating and redeveloping guidance and terms of reference, informed by current practice and experience |
| Organisation | Medical Research Council (MRC) |
| Department | MRC ConDuCT Trials Methodology Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to collaborative research project |
| Collaborator Contribution | Review current guidelines, Establish new recommendations, Rebise and redevelop terms of reference. publication late 2015 and ongoing collaboration expected. |
| Impact | publication-26715378 http://www.trialsjournal.com/content/16/1/597 Development of a comprehensive Terms of Reference document. |
| Start Year | 2012 |
| Description | R30- Trial Steering Committees for randomised controlled trials: updating and redeveloping guidance and terms of reference, informed by current practice and experience |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to collaborative research project |
| Collaborator Contribution | Review current guidelines, Establish new recommendations, Rebise and redevelop terms of reference. publication late 2015 and ongoing collaboration expected. |
| Impact | publication-26715378 http://www.trialsjournal.com/content/16/1/597 Development of a comprehensive Terms of Reference document. |
| Start Year | 2012 |
| Description | R30- Trial Steering Committees for randomised controlled trials: updating and redeveloping guidance and terms of reference, informed by current practice and experience |
| Organisation | University of Aberdeen |
| Department | Health Services Research Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to collaborative research project |
| Collaborator Contribution | Review current guidelines, Establish new recommendations, Rebise and redevelop terms of reference. publication late 2015 and ongoing collaboration expected. |
| Impact | publication-26715378 http://www.trialsjournal.com/content/16/1/597 Development of a comprehensive Terms of Reference document. |
| Start Year | 2012 |
| Description | R30- Trial Steering Committees for randomised controlled trials: updating and redeveloping guidance and terms of reference, informed by current practice and experience |
| Organisation | University of Edinburgh |
| Department | Centre for Population Health Sciences |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to collaborative research project |
| Collaborator Contribution | Review current guidelines, Establish new recommendations, Rebise and redevelop terms of reference. publication late 2015 and ongoing collaboration expected. |
| Impact | publication-26715378 http://www.trialsjournal.com/content/16/1/597 Development of a comprehensive Terms of Reference document. |
| Start Year | 2012 |
| Description | R31 Methods for risk (harm) benefit analysis in health technology |
| Organisation | Imperial College London |
| Department | School of Public Health |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network support working provided monetary support and also working with Northwest, All-Ireland, MRC-CTSU Hubs. |
| Collaborator Contribution | Two day workshop, publications etc |
| Impact | Led to further funding and PhD studentship. Also contributed to the Academy of Medical Sciences consultation - 'How does society use evidence to judge the risks and benefits of medicines?' call for evidence questions The principal objectives of the workshop were to learn from regulatory experience, define the need and methods for benefit -risk analysis (BRA) in different contexts, identify methods for preference elicitation, and develop a short list of prioritised research topics. No publications were produced. |
| Start Year | 2012 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | Hub at the MRC/CRUK/BHF Clinical Trial Service Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Department | Faculty of Epidemiology and Population Health |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | Queen's University Belfast |
| Department | The All-Ireland Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | Swansea University |
| Department | College of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | University of Bristol |
| Department | Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials (ConDuCT) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | University of Glasgow |
| Department | Robertson Centre for Biostatistics Glasgow |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R40 Use of the electronic health record in the design and conduct of clinical trials |
| Organisation | University of Leeds |
| Department | Leeds Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application involves Hubs in the Health Informatics Working Group. The meeting fits with the aims of the HTMR Network in a number of ways. It will raise the national profile of HTMR Network activities in health informatics within the clinical trials research community and beyond. |
| Collaborator Contribution | Network funding provided to develop collaboration and new work in Health Informatics. Work undertaken included: 1. A survey of UK and Ireland CTUs was undertaken to gather information on how they: (i) identify available data sources and assess them for suitability in relation to recruitment feasibility assessment; (ii) identify potential patients for studies via the electronic patient record and the challenges they experience; (iii) use the EPR for outcome data collection and determine the suitability of such data sources. 2. Case studies from the survey were presented at the workshop. |
| Impact | 55 delegates from the MRC HTMR, Farr Institute, eHIRC, HeRC and pharmaceutical industry attended the workshop which comprised 4 sessions on the use of electronic databases in supporting trials and a small group session to exchange ideas about methodological research priorities to advance this research area. Presentations are hosted here : http://methodologyhubs.mrc.ac.uk/index.php?cID=261 This led to the formation of the Health Informatics Working Group http://methodologyhubs.mrc.ac.uk/research/working-groups/health-informatics/ |
| Start Year | 2013 |
| Description | R42: CONNECT study: guidelines to inform consent methods in paediatric emergency medicine and urgent care trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application is a collaboration between multiple trials groups and stakeholders to engage relevant communities whose involvement will be key to ensuring that CONNECT guidelines are ethically appropriate, meet the needs of families and will be used by practitioners involved in paediatric EC clinical trial recruitment. |
| Collaborator Contribution | Ran a one-day meeting to: 1) Bring together experts and PPI representatives to develop CONNECT study guidance on approaches to consent in children's critical care trials; 2) Engage key stakeholders to help raise awareness of the study and outputs as part of the CONNECT dissemination strategy. |
| Impact | Guidance produced which should impact on research consent doi: 10.1136/bmjopen-2015-008522 and DOI: 10.1136/archdischild-2015-309245 listed on Network guidance pack pages also http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ |
| Start Year | 2013 |
| Description | R42: CONNECT study: guidelines to inform consent methods in paediatric emergency medicine and urgent care trials |
| Organisation | University of Birmingham |
| Department | Medicine, Ethics, Society & History (MESH) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application is a collaboration between multiple trials groups and stakeholders to engage relevant communities whose involvement will be key to ensuring that CONNECT guidelines are ethically appropriate, meet the needs of families and will be used by practitioners involved in paediatric EC clinical trial recruitment. |
| Collaborator Contribution | Ran a one-day meeting to: 1) Bring together experts and PPI representatives to develop CONNECT study guidance on approaches to consent in children's critical care trials; 2) Engage key stakeholders to help raise awareness of the study and outputs as part of the CONNECT dissemination strategy. |
| Impact | Guidance produced which should impact on research consent doi: 10.1136/bmjopen-2015-008522 and DOI: 10.1136/archdischild-2015-309245 listed on Network guidance pack pages also http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ |
| Start Year | 2013 |
| Description | R42: CONNECT study: guidelines to inform consent methods in paediatric emergency medicine and urgent care trials |
| Organisation | University of Bristol |
| Department | Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials (ConDuCT) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application is a collaboration between multiple trials groups and stakeholders to engage relevant communities whose involvement will be key to ensuring that CONNECT guidelines are ethically appropriate, meet the needs of families and will be used by practitioners involved in paediatric EC clinical trial recruitment. |
| Collaborator Contribution | Ran a one-day meeting to: 1) Bring together experts and PPI representatives to develop CONNECT study guidance on approaches to consent in children's critical care trials; 2) Engage key stakeholders to help raise awareness of the study and outputs as part of the CONNECT dissemination strategy. |
| Impact | Guidance produced which should impact on research consent doi: 10.1136/bmjopen-2015-008522 and DOI: 10.1136/archdischild-2015-309245 listed on Network guidance pack pages also http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ |
| Start Year | 2013 |
| Description | R42: CONNECT study: guidelines to inform consent methods in paediatric emergency medicine and urgent care trials |
| Organisation | University of Oxford |
| Department | Ethox Centre |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided: This application is a collaboration between multiple trials groups and stakeholders to engage relevant communities whose involvement will be key to ensuring that CONNECT guidelines are ethically appropriate, meet the needs of families and will be used by practitioners involved in paediatric EC clinical trial recruitment. |
| Collaborator Contribution | Ran a one-day meeting to: 1) Bring together experts and PPI representatives to develop CONNECT study guidance on approaches to consent in children's critical care trials; 2) Engage key stakeholders to help raise awareness of the study and outputs as part of the CONNECT dissemination strategy. |
| Impact | Guidance produced which should impact on research consent doi: 10.1136/bmjopen-2015-008522 and DOI: 10.1136/archdischild-2015-309245 listed on Network guidance pack pages also http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ |
| Start Year | 2013 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | Newcastle University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | University of Edinburgh |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | University of Nottingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Development of Guidance for Statistical Analysis Plans for Clinical Trials |
| Organisation | University of Oxford |
| Department | National Perinatal Epidemiology Unit Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Research Collaboration- Network funded project |
| Collaborator Contribution | Research collaborations in developing the project |
| Impact | None as yet. Expected that the key output of this project will be the development of a guidance document for SAPs which will be submitted for publication. A secondary output will be the points to consider document for the content of a SOP for SAP. |
| Start Year | 2014 |
| Description | R44 Impact award Development of Guidance for Statistical Analysis Plans for Clinical Trials. |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | Increasing calls for transparency, reproducibility and data sharing within clinical trials have led to a greater emphasis on the early development and publication of robust Statistical Analysis Plans (SAPs). Funded by the HTMR, a minimum set of items for SAPs was agreed following an extensive and iterative development process involving funders, regulatory authorities, journals and researchers to address a marked variation in practice. The subsequent publication in JAMA was supported by an editorial piece and has been cited 36 times in the last 18 months according to google scholar, highlighting the international importance of this research. The guidance is now widely used within UK registered CTU Standard Operating Procedures and is listed within the EQUATOR website, the Clinical Trials Toolkit and the Global Health Network resources. In addition, multiple international requests have been made for a downloadable checklist to be made available, based on the contents list, in a similar manner to CONSORT etc. A number of ongoing initiatives demonstrate the relevance of the SAP work, but also the failure of it to be included or cited. For example, the FDA require 'appropriate statistical content' to be made publically available alongside the results of clinical trials, but they fail to define what this entails. Data sharing policies from the Wellcome Trust and the NIHR also fail to cite the guidance. In addition, SAPs continue to be published in the supplementary material of journals, or are requested as part of the submission process but not used. Journals do not provide any guidance to their reviewers on what they should expect with regards to the SAPs they are being provided as part of peer review. Funding is requested for a research assistant from 1st August to 31st December at 0.2FTE to maximise the impact of the SAP Work by: • Creating a downloadable version of the SAP checklist from a dedicated website as well as the EQUATOR website. The development of a small dedicated website will place the guidance in line with similar pieces of work (e.g. PRISMA, CONSORT) and will allow tracking of key metrics (visitors and downloads) to measure impact. This resource will be disseminated via social media, newsletters and emails to CTUs, network partners, funders, journals and regulatory agencies. • Challenging funders of clinical trials (e.g. Wellcome Trust, NIHR) to request SAPS alongside protocols to ensure pre-specification of statistical analysis plans within the public domain. They will also be encouraged to cite the SAP checklist and use it as an assessment tool within funding awards and data sharing policies. • Lobbying the FDA to cite the guidance when defining 'appropriate' statistical content within the National Institutes of Health Final Rule for Clinical Trials Registration and Results Information Submission. • Challenging journals (e.g. Trials, Clinical Trials, JAMA) to recommend publication of SAPs either as a stand alone publication or alongside protocols, using the checklist as a peer review assessment tool. We plan to utilise existing contacts within key organisation made during the SAP project as well as new connections made through the newly formed MRC-NIHR TMRP to deliver this. |
| Impact | na |
| Start Year | 2019 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | King's College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | Newcastle University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | University of Edinburgh |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R45: Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded research project This aim of this project is to address the current difficulties experienced in recruitment of statistical expertise for clinical trial oversight committees and to address concerns of capacity of this level of expertise by identifying and offering training opportunities for junior statisticians. This project will also reach consensus on key criteria a statistician should be expected to have attained prior to undertaking such roles providing benchmarks for upcoming junior statisticians. |
| Collaborator Contribution | Research collaborators working on development of database |
| Impact | Expected outcome- development of a database |
| Start Year | 2014 |
| Description | R46- Exploring the concept of a Patient Centre Clinical Trial: a workshop |
| Organisation | NHS England |
| Department | National Research Ethics Service |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network funded project- This is a collaborative workshop- inviting a selected group of people to an initial workshop, with the aim to: (a) Draft a definition of a 'Patient Centred Clinical Trial' (b) Explore dimensions of a 'Patient Centred Clinical Trial' and how they might be measured (c) Consider the key research issues relating to a 'Patient Centred Clinical Trial' (d) Consider how best to engage with relevant communities of stakeholders |
| Collaborator Contribution | Network funding provided- each partner contributed to planning and development of workshop. |
| Impact | 2 workshops in Manchester, with a range of stakeholders, including academics, patients, patient and public involvement organisations, and representatives from charities, ethics committees, funders and the research networks. Some people attended both workshops, but we also brought in new people to workshop 2 after the initial discussions in workshop 1. http://www.population-health.manchester.ac.uk/patientcentredtrials/ Have also prepared presentations for: o North West Hub Trials Methodology Research conference (April 2015) o User Involvement in Voluntary Organisations Shared Learning Group (London: January 2015) o SCOPE Summit (Florida: February 2015) o Health Services Research Network (Nottingham: July 2015) |
| Start Year | 2014 |
| Description | R46- Exploring the concept of a Patient Centre Clinical Trial: a workshop |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project- This is a collaborative workshop- inviting a selected group of people to an initial workshop, with the aim to: (a) Draft a definition of a 'Patient Centred Clinical Trial' (b) Explore dimensions of a 'Patient Centred Clinical Trial' and how they might be measured (c) Consider the key research issues relating to a 'Patient Centred Clinical Trial' (d) Consider how best to engage with relevant communities of stakeholders |
| Collaborator Contribution | Network funding provided- each partner contributed to planning and development of workshop. |
| Impact | 2 workshops in Manchester, with a range of stakeholders, including academics, patients, patient and public involvement organisations, and representatives from charities, ethics committees, funders and the research networks. Some people attended both workshops, but we also brought in new people to workshop 2 after the initial discussions in workshop 1. http://www.population-health.manchester.ac.uk/patientcentredtrials/ Have also prepared presentations for: o North West Hub Trials Methodology Research conference (April 2015) o User Involvement in Voluntary Organisations Shared Learning Group (London: January 2015) o SCOPE Summit (Florida: February 2015) o Health Services Research Network (Nottingham: July 2015) |
| Start Year | 2014 |
| Description | R46- Exploring the concept of a Patient Centre Clinical Trial: a workshop |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project- This is a collaborative workshop- inviting a selected group of people to an initial workshop, with the aim to: (a) Draft a definition of a 'Patient Centred Clinical Trial' (b) Explore dimensions of a 'Patient Centred Clinical Trial' and how they might be measured (c) Consider the key research issues relating to a 'Patient Centred Clinical Trial' (d) Consider how best to engage with relevant communities of stakeholders |
| Collaborator Contribution | Network funding provided- each partner contributed to planning and development of workshop. |
| Impact | 2 workshops in Manchester, with a range of stakeholders, including academics, patients, patient and public involvement organisations, and representatives from charities, ethics committees, funders and the research networks. Some people attended both workshops, but we also brought in new people to workshop 2 after the initial discussions in workshop 1. http://www.population-health.manchester.ac.uk/patientcentredtrials/ Have also prepared presentations for: o North West Hub Trials Methodology Research conference (April 2015) o User Involvement in Voluntary Organisations Shared Learning Group (London: January 2015) o SCOPE Summit (Florida: February 2015) o Health Services Research Network (Nottingham: July 2015) |
| Start Year | 2014 |
| Description | R46- Exploring the concept of a Patient Centre Clinical Trial: a workshop |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project- This is a collaborative workshop- inviting a selected group of people to an initial workshop, with the aim to: (a) Draft a definition of a 'Patient Centred Clinical Trial' (b) Explore dimensions of a 'Patient Centred Clinical Trial' and how they might be measured (c) Consider the key research issues relating to a 'Patient Centred Clinical Trial' (d) Consider how best to engage with relevant communities of stakeholders |
| Collaborator Contribution | Network funding provided- each partner contributed to planning and development of workshop. |
| Impact | 2 workshops in Manchester, with a range of stakeholders, including academics, patients, patient and public involvement organisations, and representatives from charities, ethics committees, funders and the research networks. Some people attended both workshops, but we also brought in new people to workshop 2 after the initial discussions in workshop 1. http://www.population-health.manchester.ac.uk/patientcentredtrials/ Have also prepared presentations for: o North West Hub Trials Methodology Research conference (April 2015) o User Involvement in Voluntary Organisations Shared Learning Group (London: January 2015) o SCOPE Summit (Florida: February 2015) o Health Services Research Network (Nottingham: July 2015) |
| Start Year | 2014 |
| Description | R46- Exploring the concept of a Patient Centre Clinical Trial: a workshop |
| Organisation | University of York |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project- This is a collaborative workshop- inviting a selected group of people to an initial workshop, with the aim to: (a) Draft a definition of a 'Patient Centred Clinical Trial' (b) Explore dimensions of a 'Patient Centred Clinical Trial' and how they might be measured (c) Consider the key research issues relating to a 'Patient Centred Clinical Trial' (d) Consider how best to engage with relevant communities of stakeholders |
| Collaborator Contribution | Network funding provided- each partner contributed to planning and development of workshop. |
| Impact | 2 workshops in Manchester, with a range of stakeholders, including academics, patients, patient and public involvement organisations, and representatives from charities, ethics committees, funders and the research networks. Some people attended both workshops, but we also brought in new people to workshop 2 after the initial discussions in workshop 1. http://www.population-health.manchester.ac.uk/patientcentredtrials/ Have also prepared presentations for: o North West Hub Trials Methodology Research conference (April 2015) o User Involvement in Voluntary Organisations Shared Learning Group (London: January 2015) o SCOPE Summit (Florida: February 2015) o Health Services Research Network (Nottingham: July 2015) |
| Start Year | 2014 |
| Description | R47: Selective reporting in clinical trials: a feasibility study for examining discrepancies between trial protocols and trial reports submitted to journals |
| Organisation | British Medical Association (BMA) |
| Department | British Medical Journal (BMJ) |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Network funding for project |
| Collaborator Contribution | Collaborators will be working on research to review manuscripts compared against protocols of clinical trials submitted to journals, with feasibility assessed in this initial study involving the BMJ. |
| Impact | 27105712 |
| Start Year | 2014 |
| Description | R47: Selective reporting in clinical trials: a feasibility study for examining discrepancies between trial protocols and trial reports submitted to journals |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for project |
| Collaborator Contribution | Collaborators will be working on research to review manuscripts compared against protocols of clinical trials submitted to journals, with feasibility assessed in this initial study involving the BMJ. |
| Impact | 27105712 |
| Start Year | 2014 |
| Description | R47: Selective reporting in clinical trials: a feasibility study for examining discrepancies between trial protocols and trial reports submitted to journals |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for project |
| Collaborator Contribution | Collaborators will be working on research to review manuscripts compared against protocols of clinical trials submitted to journals, with feasibility assessed in this initial study involving the BMJ. |
| Impact | 27105712 |
| Start Year | 2014 |
| Description | R47: Selective reporting in clinical trials: a feasibility study for examining discrepancies between trial protocols and trial reports submitted to journals |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding for project |
| Collaborator Contribution | Collaborators will be working on research to review manuscripts compared against protocols of clinical trials submitted to journals, with feasibility assessed in this initial study involving the BMJ. |
| Impact | 27105712 |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | National Institute for Health Research |
| Department | Health Technology Assessment Programme (HTA) |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | University of Nottingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R50:Online database for SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) outlines and their data |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funded project. This project works in collaboration with the Global Health Network. |
| Collaborator Contribution | All partners are contributing to the development of a searchable online database for details of SWAT and SWAR. The funding requested was to employ a part-time research assistant at Queen's University Belfast to develop a repository for the SWAT (Study Within A Trial) and SWAR (Study Within A Review) outlines and data. |
| Impact | http://www.methodologyhubs.mrc.ac.uk/files/2914/4828/9413/finalreort_R50.pdf The findings of SWAR-2 were published in Journal of the Royal Society of Medicine in November 2014 and the findings of SWAT1 were published in Trials in May 2015. A preliminary bundle of these SWAT has been shared with selected Clinical Trial Units and included in the materials for the University of Oxford's MSc in Evidence Based Health Care. SWATs were discussed in the publication below http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2012.01169.x/abstract |
| Start Year | 2014 |
| Description | R52 "How to be a good Chief Investigator; planning for a successful trial"- 2 workshops |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to support two workshops focussed on training Cheif Investigators in new trials methodologies. |
| Collaborator Contribution | PArtners in organising, developing and manging new workshops for training in trials methodology. Funds are sought to run 2 workshops (one in Manchester and one in London) aimed at current and aspiring clinical trials Chief Investigators (CI). Each workshop will aim to include 40 people drawn from those already a CI on a trial already funded through NIHR, BHF, CRUK or AR UK or other non-commercial funding bodies and those aspiring to lead trials. |
| Impact | Two workshops were held in 2015- February and September. Over 60 new CIs have been reached through this initiative. A further workshop is planned for 2016. This collaboration reaches clinicians from a range of disciplines, who are all new Chief Investigators on trials. |
| Start Year | 2014 |
| Description | R52 "How to be a good Chief Investigator; planning for a successful trial"- 2 workshops |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to support two workshops focussed on training Cheif Investigators in new trials methodologies. |
| Collaborator Contribution | PArtners in organising, developing and manging new workshops for training in trials methodology. Funds are sought to run 2 workshops (one in Manchester and one in London) aimed at current and aspiring clinical trials Chief Investigators (CI). Each workshop will aim to include 40 people drawn from those already a CI on a trial already funded through NIHR, BHF, CRUK or AR UK or other non-commercial funding bodies and those aspiring to lead trials. |
| Impact | Two workshops were held in 2015- February and September. Over 60 new CIs have been reached through this initiative. A further workshop is planned for 2016. This collaboration reaches clinicians from a range of disciplines, who are all new Chief Investigators on trials. |
| Start Year | 2014 |
| Description | R52 "How to be a good Chief Investigator; planning for a successful trial"- 2 workshops |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to support two workshops focussed on training Cheif Investigators in new trials methodologies. |
| Collaborator Contribution | PArtners in organising, developing and manging new workshops for training in trials methodology. Funds are sought to run 2 workshops (one in Manchester and one in London) aimed at current and aspiring clinical trials Chief Investigators (CI). Each workshop will aim to include 40 people drawn from those already a CI on a trial already funded through NIHR, BHF, CRUK or AR UK or other non-commercial funding bodies and those aspiring to lead trials. |
| Impact | Two workshops were held in 2015- February and September. Over 60 new CIs have been reached through this initiative. A further workshop is planned for 2016. This collaboration reaches clinicians from a range of disciplines, who are all new Chief Investigators on trials. |
| Start Year | 2014 |
| Description | R53 Impact award: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Bristol |
| Department | School of Social and Community Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The original HTMR Network award was to develop, deliver and evaluate RCT recruiter training workshops to enhance recruitment and informed consent. We developed and delivered four 1-day workshops to surgeons and research nurses. We showed that these workshops, with a focus on addressing the emotional and intellectual challenges of recruiting patients to surgical RCTs, increased confidence with recruitment, raised awareness of hidden challenges and impacted positively on self-assessed recruitment practice.1 Since then we have delivered three further workshops and had several requests to provide this training within specific RCTs. We have also used discrete elements of the training material to train medical students and surgical trainees in RCT recruitment through collaborations with the Universities of Birmingham (GRANULE) and Oxford (BOSTiC). Clearly there is a need to continue training recruiters in addressing recruitment difficulties. One of the key outcomes from our original project was the challenges and discomfort that recruiters have with responding to patients' treatment preferences and conveying equipoise as part of this. This cut across different trial contexts and health professionals and is an area that warrants further attention. We therefore intend to increase the dissemination and impact of our original project by: (1) further refining and advancing the training material by reviewing recent literature and audio-recordings of recruiter-patient discussions across a range of diverse RCTs to identify effective practice in managing the challenging aspects of RCT recruitment discussions; (2) disseminating the refined training material more widely by tailoring it to different audiences (expanding to trial designers in addition to trial recruiters); and (3) developing a sustainable annual short training course to optimise RCT recruitment and informed consent. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | R53 Impact award: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The original HTMR Network award was to develop, deliver and evaluate RCT recruiter training workshops to enhance recruitment and informed consent. We developed and delivered four 1-day workshops to surgeons and research nurses. We showed that these workshops, with a focus on addressing the emotional and intellectual challenges of recruiting patients to surgical RCTs, increased confidence with recruitment, raised awareness of hidden challenges and impacted positively on self-assessed recruitment practice.1 Since then we have delivered three further workshops and had several requests to provide this training within specific RCTs. We have also used discrete elements of the training material to train medical students and surgical trainees in RCT recruitment through collaborations with the Universities of Birmingham (GRANULE) and Oxford (BOSTiC). Clearly there is a need to continue training recruiters in addressing recruitment difficulties. One of the key outcomes from our original project was the challenges and discomfort that recruiters have with responding to patients' treatment preferences and conveying equipoise as part of this. This cut across different trial contexts and health professionals and is an area that warrants further attention. We therefore intend to increase the dissemination and impact of our original project by: (1) further refining and advancing the training material by reviewing recent literature and audio-recordings of recruiter-patient discussions across a range of diverse RCTs to identify effective practice in managing the challenging aspects of RCT recruitment discussions; (2) disseminating the refined training material more widely by tailoring it to different audiences (expanding to trial designers in addition to trial recruiters); and (3) developing a sustainable annual short training course to optimise RCT recruitment and informed consent. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | R53 Impact award: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network provided funding |
| Collaborator Contribution | The original HTMR Network award was to develop, deliver and evaluate RCT recruiter training workshops to enhance recruitment and informed consent. We developed and delivered four 1-day workshops to surgeons and research nurses. We showed that these workshops, with a focus on addressing the emotional and intellectual challenges of recruiting patients to surgical RCTs, increased confidence with recruitment, raised awareness of hidden challenges and impacted positively on self-assessed recruitment practice.1 Since then we have delivered three further workshops and had several requests to provide this training within specific RCTs. We have also used discrete elements of the training material to train medical students and surgical trainees in RCT recruitment through collaborations with the Universities of Birmingham (GRANULE) and Oxford (BOSTiC). Clearly there is a need to continue training recruiters in addressing recruitment difficulties. One of the key outcomes from our original project was the challenges and discomfort that recruiters have with responding to patients' treatment preferences and conveying equipoise as part of this. This cut across different trial contexts and health professionals and is an area that warrants further attention. We therefore intend to increase the dissemination and impact of our original project by: (1) further refining and advancing the training material by reviewing recent literature and audio-recordings of recruiter-patient discussions across a range of diverse RCTs to identify effective practice in managing the challenging aspects of RCT recruitment discussions; (2) disseminating the refined training material more widely by tailoring it to different audiences (expanding to trial designers in addition to trial recruiters); and (3) developing a sustainable annual short training course to optimise RCT recruitment and informed consent. |
| Impact | No impact yet |
| Start Year | 2018 |
| Description | R53: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for workshop development. Funds provided to develop, deliver and evaluate training courses for recruiters to randomised trials. |
| Collaborator Contribution | Each partner is contributing to the development of the course. the workshops are being led by a researcher at the University of Bristol |
| Impact | Workshops have been held: 24 March 2015for surgeons 20 April 2015 for research nurses and May 5 2016 for surgeons |
| Start Year | 2014 |
| Description | R53: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for workshop development. Funds provided to develop, deliver and evaluate training courses for recruiters to randomised trials. |
| Collaborator Contribution | Each partner is contributing to the development of the course. the workshops are being led by a researcher at the University of Bristol |
| Impact | Workshops have been held: 24 March 2015for surgeons 20 April 2015 for research nurses and May 5 2016 for surgeons |
| Start Year | 2014 |
| Description | R53: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for workshop development. Funds provided to develop, deliver and evaluate training courses for recruiters to randomised trials. |
| Collaborator Contribution | Each partner is contributing to the development of the course. the workshops are being led by a researcher at the University of Bristol |
| Impact | Workshops have been held: 24 March 2015for surgeons 20 April 2015 for research nurses and May 5 2016 for surgeons |
| Start Year | 2014 |
| Description | R53: Developing, delivering and evaluating training courses for recruiters to randomised trials |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for workshop development. Funds provided to develop, deliver and evaluate training courses for recruiters to randomised trials. |
| Collaborator Contribution | Each partner is contributing to the development of the course. the workshops are being led by a researcher at the University of Bristol |
| Impact | Workshops have been held: 24 March 2015for surgeons 20 April 2015 for research nurses and May 5 2016 for surgeons |
| Start Year | 2014 |
| Description | R54: Meta-Modelling for Value of Information Calculations Workshop |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to develop a new workshop on metamodelling techniques. |
| Collaborator Contribution | Partners in development of a workshop. |
| Impact | Workshop undertaken 19th September 2014. The one day workshop to explore meta-modelling techniques to improve value of information computation time, was held on 19 th September 2014. Presentations were given by Nicky Welton (Bristol), Jason Madan (Warwick), Malcolm Price (Birmingham), Mark Strong (Sheffield), Fasihul Alum (South Wales), Gianluca Baio (UCL), and Chris Jackson (Cambridge). The workshop was attended by 31 delegates (plus the 7 speakers). There have been a lot of recent developments on metamodelling techniques, and this workshop enabled these methods to be presented together with demonstrations of software that has recently been made available , using a common example. The feedback from the workshop delegates was very positive, and the discussions at the end of the day indicated that the software developments in particular had made the methods more accessible for use in real applications |
| Start Year | 2014 |
| Description | R54: Meta-Modelling for Value of Information Calculations Workshop |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to develop a new workshop on metamodelling techniques. |
| Collaborator Contribution | Partners in development of a workshop. |
| Impact | Workshop undertaken 19th September 2014. The one day workshop to explore meta-modelling techniques to improve value of information computation time, was held on 19 th September 2014. Presentations were given by Nicky Welton (Bristol), Jason Madan (Warwick), Malcolm Price (Birmingham), Mark Strong (Sheffield), Fasihul Alum (South Wales), Gianluca Baio (UCL), and Chris Jackson (Cambridge). The workshop was attended by 31 delegates (plus the 7 speakers). There have been a lot of recent developments on metamodelling techniques, and this workshop enabled these methods to be presented together with demonstrations of software that has recently been made available , using a common example. The feedback from the workshop delegates was very positive, and the discussions at the end of the day indicated that the software developments in particular had made the methods more accessible for use in real applications |
| Start Year | 2014 |
| Description | R54: Meta-Modelling for Value of Information Calculations Workshop |
| Organisation | University of Cambridge |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided to develop a new workshop on metamodelling techniques. |
| Collaborator Contribution | Partners in development of a workshop. |
| Impact | Workshop undertaken 19th September 2014. The one day workshop to explore meta-modelling techniques to improve value of information computation time, was held on 19 th September 2014. Presentations were given by Nicky Welton (Bristol), Jason Madan (Warwick), Malcolm Price (Birmingham), Mark Strong (Sheffield), Fasihul Alum (South Wales), Gianluca Baio (UCL), and Chris Jackson (Cambridge). The workshop was attended by 31 delegates (plus the 7 speakers). There have been a lot of recent developments on metamodelling techniques, and this workshop enabled these methods to be presented together with demonstrations of software that has recently been made available , using a common example. The feedback from the workshop delegates was very positive, and the discussions at the end of the day indicated that the software developments in particular had made the methods more accessible for use in real applications |
| Start Year | 2014 |
| Description | Stratified Medicine WG |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Stratified Medicine Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- Stratified Medicine is about tailoring treatments to specific patients, helping to ensure the highest chance of benefit and minimising the potential for harm or unnecessary treatment The Stratified Medicine Working Group collaborates to look at novel designs for biomarker-stratified trials, and to bring the stratified medicine approach into a wider range of disease areas, complementing work already done in the widely studied examples of cancer and heart disease. Future Objectives- The Working Group is preparing a guidance paper to help people reading a stratified medicine research paper, and has started to explore means for delivering advice to applicants to the MRC Research Panel on Stratified Medicine. Members of the Working Group are also planning to develop prognostic models that help in the prediction of harms and benefits following the use of thrombolysis to treat stroke, drawing on individual participant data meta-analysis of clinical trials. |
| Impact | ongoing collaborations. |
| Start Year | 2012 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology |