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.

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.

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.

Organisations

Publications

10 25 50

 
Description 'How does society use evidence to judge the risks and benefits of medicines?' call for evidence
Geographic Reach National 
Policy Influence Type Participation in a national consultation
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 Membership of a guidance 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 Trials Methodology Research Partnership
Amount £458,666 (GBP)
Funding ID MR/S014357/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 06/2019 
End 05/2022
 
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 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 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 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 Public 
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 Public 
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 Learned Society 
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 Public 
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 Charity/Non Profit 
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 Methodological issues in trials funded by Arthritis Research UK 
Organisation Versus Arthritis
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 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 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 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 Public 
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 Public 
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 Public 
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 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 Medical Research Council (MRC)
Department MRC North West Hub for Trials Methodology Research
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 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 Hospitals 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Academic/University 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Multiple 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Public 
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 Multiple 
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 Public 
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 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 Public 
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 Trial Conduct 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 Trial Conduct Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members.
Collaborator Contribution Scope- The Trial Conduct Working Group covers a wide range of aspects of trials. A Core Group, whose members represent each of the Hubs carrying out research into trial conduct as well as other important groups who are active in this field, meets regularly to facilitate and develop collaborative research into trial conduct. Recent activities have focussed on trial monitoring and the role of Trial Steering Committees. The latter includes new collaborative research which arose in response to issues raised in the HTMR's engagement with one of our key stakeholders, the National Institute for Health Research Health Technology Assessment programme. Future objectives- The Working Group will continue to focus on making trials more efficient and cost-effective, and in providing a link point between the HTMR Network and other organisations, including responding to recent consultations on the EU Clinical Trials Directive and access to data from trials. Its members are working on a variety of projects, including the SWAT (Study Within a Trial) programme, which is led by the All-Ireland Hub. The first SWAT has been conducted to examine the impact of site visits by the principal investigator in a multi-centre trial and several SWAT protocols will be published by the end of 2013.
Impact ongoing avities including wedbinars and research project development
Start Year 2010
 
Description Trial Recruitment 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 Trial Recruitment Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members.
Collaborator Contribution Scope- The Trial Recruitment Working Group is identifying the most effective and efficient strategies for recruitment to trials, with methodology studies inside and outside the Hubs. It facilitates networking and collaborative research across the Hubs to improve trial recruitment, and collaborates with the UKCRC Registered CTU Network to implement, evaluate and use recruitment interventions across clinical trials in the UK and beyond. Future Objectives- The collaboration between this Working Group and the CTUs will continue, with trial recruitment identified as the top priority for methodology research by the CTU Directors in a survey led by the North West Hub. The Group is reviewing difficulties that arise in trial recruitment from trial approvals through to trial completion on time and to cost, and generating momentum to make the on-going evaluation of new methods a routine activity. The Working Group's projects will help with the understanding of the recruitment process, address recruiter and other trial staff training issues, develop feasibility and pilot studies, build on innovative qualitative methods to study various aspects of recruitment, evaluate the use of health informatics approaches, improve access to 'hard to reach' patients, and develop a core outcome set for future methodological studies of patient centeredness and effectiveness in trial recruitment. There will be continued promotion of the MRC Systematic Techniques for Assisting Recruitment to Trials (MRC START) model across the UK, and use of the START website (www.population-health.manchester.ac.uk/mrcstart) as a repository for trial recruitment interventions and related protocols, encouraging wider adoption of these by trial teams and standardisation across the trial portfolio.
Impact ongoing. Received Network funding for specific collaboration on developing a recruitment database
Start Year 2010
 
Description Trials Change Lives 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Trials Change Lives- partnership developed to produce material and actitivies around International Clinical Trials Day 2014
Collaborator Contribution Mike Clarke led the initiative with all other partners contributing stories and ideas to the development of a resources of posters and ideas
Impact Collation of existing resources and links,and development of suite of posters and activities for use on international clinical trials day. http://methodologyhubs.mrc.ac.uk/research/trials-change-lives/
Start Year 2014
 
Description Trials Change Lives 
Organisation Queen's University Belfast
Department The All-Ireland Hub for Trials Methodology Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Trials Change Lives- partnership developed to produce material and actitivies around International Clinical Trials Day 2014
Collaborator Contribution Mike Clarke led the initiative with all other partners contributing stories and ideas to the development of a resources of posters and ideas
Impact Collation of existing resources and links,and development of suite of posters and activities for use on international clinical trials day. http://methodologyhubs.mrc.ac.uk/research/trials-change-lives/
Start Year 2014
 
Description Trials Change Lives 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Trials Change Lives- partnership developed to produce material and actitivies around International Clinical Trials Day 2014
Collaborator Contribution Mike Clarke led the initiative with all other partners contributing stories and ideas to the development of a resources of posters and ideas
Impact Collation of existing resources and links,and development of suite of posters and activities for use on international clinical trials day. http://methodologyhubs.mrc.ac.uk/research/trials-change-lives/
Start Year 2014
 
Description 'PIRRIST: A patient and public involvement (PPI) intervention to enhance recruitment and retention in surgical trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 'PIRRIST: A patient and public involvement (PPI) intervention to enhance recruitment and retention in surgical trials.' Department of Health Sciences, University of York (2019).

Invited talk. Jo Crocker
Year(s) Of Engagement Activity 2019
 
Description 'Trials methodology research workshop', Society for Clinical Trials, Montreal, May 2016 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination activity for trials methodology research in the UK.
Year(s) Of Engagement Activity 2016
 
Description 2014 4th student symposia HTMR 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Student meeting- organised by London Hub to encourage engagement within the student cohort

Feedback from the workshop was positive, with many students highlighting this was a perfect eent to engage with their methodology peers
Year(s) Of Engagement Activity 2014
 
Description 5th Student Symposium 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Student symposium for methodology students Directly funded by the Network or Hubs. Meeting aligned with the ICTMC2015
Year(s) Of Engagement Activity 2015
 
Description A Consensus-Driven Reporting Guidance for Adaptive Clinical Trials: An Adaptive Designs Consort Extension (ACE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dimairo et al (2018) A Consensus-Driven Reporting Guidance for Adaptive Clinical Trials: An Adaptive Designs Consort Extension (ACE) Clinical Trials 15 (Suppl. 2) A60.

Society for Clinical Trials Annual Meeting 2018 Oral presentation
Year(s) Of Engagement Activity 2018
 
Description A reanalysis of the Brazil XpertMTB/RIF stepped wedge trial using a novel cluster summary analysis method - oral presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Oral presentation by a HTMR Network student at the Current developments in cluster randomised trials and stepped wedge designs meeting. Dissemination of work.
Year(s) Of Engagement Activity 2015
 
Description ABPI PBPK workshop 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Thomas Jaki attended the ABPI MHRA PBPK Workshop on behalf of the Network. The main purpose of the meeting was described as exchanging pharmaceutical companies and regulatory authorities views on PBPK approaches as part of the submission package of a novel treatment. As a consequence of this, the discussions were mainly focussed on PBPK in the clinical rather than the pre-clinical context and around general concepts rather than specific methods. As the meeting was discussing general issues on a high level, no obvious collaboration in terms of methods development emerged.
Year(s) Of Engagement Activity 2014
 
Description Adaptive design module on MRes Experimental Cancer, Manchester, 1. March 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact • Adaptive design module on MRes Experimental Cancer, Manchester, 1. March 2019
Outreach Officer Thomas Burnett
Year(s) Of Engagement Activity 2019
 
Description Adaptive trials: acceptability, utility and versatility, Academy of Medical Sciences. London. 23. January 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Adaptive trials: acceptability, utility and versatility, Academy of Medical Sciences. London. 23. January 2019
Outreach Officer: Thomas Burnett, University of Lancaster
Year(s) Of Engagement Activity 2019
 
Description Applying the IDEAL framework to a methodological complex intervention (PIRRIST). Poster presentation at IDEAL Conference, Bristol, 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Crocker JC, Farrar N, Treweek S, Petit-Zeman S, Chant A, Bostock J, Woolfall K, Locock L, Rees S, Bulbulia R. Applying the IDEAL framework to a methodological complex intervention (PIRRIST). Poster presentation at IDEAL Conference, Bristol, 2018. Published in International Journal of Surgery 2018; 59, Supplement 1: S4, #15.

Jo Crocker received 'Best Poster' award for the above.
Year(s) Of Engagement Activity 2018
 
Description Assessing risk of bias in randomized trials (RoB 2). Cochrane Colloquium, Edinburgh, Scotland, 16-18 September 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Savovic J, MacAleenan A, Sterne J, Higgins J. Assessing risk of bias in randomized trials (RoB 2). Cochrane Colloquium, Edinburgh, Scotland, 16-18 September 2018. (Workshop 90min; delivered twice due to high demand, ~160 participants in total)
Year(s) Of Engagement Activity 2018
 
Description Biomarkers session at ICTMC2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Plenary biomarkers session at ICTMC2015 hosted by Roche and the HTMR Network. The Network Coordinator was an active developer of this project
Year(s) Of Engagement Activity 2015
URL http://ictmc.uk/programme/
 
Description Can PPI improve recruitment and retention in clinical trials?' NIHR Evaluation, Trials and Studies Coordinating Centre, Southampton (2018). 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact 'Can PPI improve recruitment and retention in clinical trials?' NIHR Evaluation, Trials and Studies Coordinating Centre, Southampton (2018).
Invited talk Jo Crocker
Year(s) Of Engagement Activity 2018
 
Description Citation analysis: a new approach to assess the uptake of core outcome sets? (KB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work followed by questions.
Year(s) Of Engagement Activity 2016
 
Description Clinical Capacity Building Panel 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Ongoing activity.
Formation of Panel of those within the Network with clinical interest to work on engagement activities and influence key partners and stakeholders in the support of clinical trials methodology and capacity building in the UK.

Regular teleconference and letters of influence issued
Guidance document in preparation
Recent meeting Jan 2016 included discussion with NIHR Dean of Trainees
Year(s) Of Engagement Activity 2014,2015,2016
URL http://methodologyhubs.mrc.ac.uk/research/clinical-capacity-building/
 
Description Courses at the Swiss Epidemiology Winter School:Assessing Bias in Randomized and Non-Randomized Studies: New Approaches, New Tools 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Courses at the Swiss Epidemiology Winter School:
Sterne & Higgins; Assessing Bias in Randomized and Non-Randomized Studies: New Approaches, New Tools; Wengen 15-17 Jan 2018
Sterne & Higgins; Assessing Bias in Randomized and Non-Randomized Studies: New Approaches, New Tools; Wengen 21-23 Jan 2019
Year(s) Of Engagement Activity 2018,2019
 
Description Development of new HTMR Network website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Development of new HTMR Network website. Provides an active live resource for research, training, webinars, events and information on trials methodology. Project managed by the Network coordinator with input from the Executive Committee of the Network. Content is regularly revised and updated, and includes live links to external stakeholders web sites and resource.
Year(s) Of Engagement Activity 2015
URL http://methodologyhubs.mrc.ac.uk/
 
Description Development of training resource as sub section of the Network website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Training resource developed as subsite of HTMR Network website. This resource is collated by the NEtwork coordinator. External partners now are aware of the reach of this site and contact us to include content on these pages to promote their events
Year(s) Of Engagement Activity 2015
URL http://methodologyhubs.mrc.ac.uk/resources/training-courses/
 
Description Farr Institute- Industry Forum 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Fizz Williamson attended a workshop organised by the Farr Institute, to build on our engagement around Health Informatics and Trials. This has led to potential new collaborations between the two Networks and with some industry partners
Year(s) Of Engagement Activity 2015
 
Description HTMR / SCT Joint Webinar Series 2018 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact HTMR / SCT Joint Webinar Series 2018
During 2018 a joint committee comprising of SCT and HTMR Members shortlisted a list of 5 webinars representing both Networks. These webinars discussed varied aspects of Clinical Trials and Trial Methodology
HTMR and SCT Members were able to view these broadcasts live and these recordings will be shared in due course.
Year(s) Of Engagement Activity 2018
 
Description HTMR Network Annual Meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This was the 7th HTMR Network Annual Meeting which was organised by the London HTMR Hub and held at Wellcome Collection 25th September 2018. It showcased the work of several hub members across the UK presenting on many different aspects of trial methodology including PhD students. It was attended by over 80 HTMR members with representatives from Industry and NIHR also in the audience.
Year(s) Of Engagement Activity 2018
URL https://www.methodologyhubs.mrc.ac.uk/workshops/annual-meeting/2018/
 
Description HTMR Network engagement with UKPHSRN 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Prof Mike Clarke attended a meeting to forge links between the HTMR Network and the PHSRN

expected further collaboration in future
Year(s) Of Engagement Activity 2013
 
Description HTMR engagement with HRA 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Primary meeting with HRA in September 2014 to discuss issues around trials methodology in the UK

possible future collaboration
Year(s) Of Engagement Activity 2014
 
Description HTMR engagement with NICE 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact First meeting with NICE R&D- likely future collaboration and discussion

tbc
Year(s) Of Engagement Activity 2014
 
Description ICTMC2015 - Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The HTMR Network organised the 3rd International Clinical Trials Methodology Conference (ICTMC2015) at Glasgow in November 2015.
Over 600 delegates attended. The conference included parallel presentations of new methods, plenary talks and keynote discussions.
Year(s) Of Engagement Activity 2015
URL http://ictmc.uk/
 
Description Implications of Misspecifed Mixed Effect Models in Stepped Wedge Trial Analysis: How Wrong Can It Be? Poster Presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Poster presentation given by HTMR Network student at the First International Conference of Stepped Wedge Trial Design. Dissemination of work.
Year(s) Of Engagement Activity 2016
 
Description International Advisory Group for the HTMR Network 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The first meeting of the IAG for the HTMR Network was held in summer 2015.
This provided external input and insight into the management of the HTMR Network.
Year(s) Of Engagement Activity 2015
 
Description International Clinical Trials Day 2015 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Continued development of the Trials Change Lives resource- promoted as part of ICTD2015
Year(s) Of Engagement Activity 2015
URL http://methodologyhubs.mrc.ac.uk/research/trials-change-lives/
 
Description Jamie Kirkham: Mitigating the problem of outcome reporting bias BMJ Opinion Article 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Jamie Kirkham: Mitigating the problem of outcome reporting bias
BMJ Opinion Article to accompany Research Paper: Kirkham et al. 2018
Outcome reporting bias in trials: a methodological approach for assessment and adjustment in systematic reviews
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3802
Year(s) Of Engagement Activity 2018
URL https://blogs.bmj.com/bmj/2018/10/05/jamie-kirkham-mitigating-problem-outcome-reporting-bias/
 
Description Matt Sydes - attendance PRC meeting at CRUK 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Matt Sydes attended the CRUK Population Research Committee on behalf of the Network in spring 2015. This presentation provided an opportunity to engage with one of the UK's main trial funders. It was also an opportunity to highlight the work of the Network and to discuss any pertinent issues in trials methodology research.
Year(s) Of Engagement Activity 2015
 
Description Methods for conducting systematic reviews and meta-analyses" course to postgraduate students on Johns Hopkins doctoral or masters programs (RoB) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Johns Hopkins Medical School doctoral or masters programs course:
Tianjing Li, associate professor at Johns Hopkins Medical School, taught RoB 2 on the "Methods for conducting systematic reviews and meta-analyses" course to postgraduate students on Johns Hopkins doctoral or masters programs, February 2019.
Acting as expert advisers (but also evidence that our methods are being adopted and taught at other institutions internationally):
Higgins and Savovic have advised Dr Tianjing Li, associate professor at Johns Hopkins Medical School, on aspects of the RoB 2 tool that she taught on the "Methods for conducting systematic reviews and meta-analyses" course to postgraduate students on Johns Hopkins doctoral or masters programs, February 2019.
Year(s) Of Engagement Activity 2019
 
Description Network Annual Meeting 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Annual Meeting of Network Hub members. A free meeting hosted in Bristol in spring 2015 showcased some of the work being undertaken by the Hubs and Working Groups.
The meeting provided an opportunity for engagement and discussion between Hub members, and a chance to showcase areas of interest in trials methodology.
The event included a Dragons Den type event, as an opportunity for researchers to present their ideas informally to the audience, with feedback from a panel of experts. A prize was given for the best presentation.
Year(s) Of Engagement Activity 2015
URL http://methodologyhubs.mrc.ac.uk/workshops/annual-meeting/20151/
 
Description Optimising Recruitment in Clinical Trials in Surgery: How Do Surgical Trainees Working Together Achieve Success? Lane et al. SCT 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lane et al (2018) Optimising Recruitment in Clinical Trials in Surgery: How Do Surgical Trainees Working Together Achieve Success? Clinical Trials 15 (Suppl. 2) A62.

Presentation given at the Society of Clinical Trials, 2018 annual meeting.
Year(s) Of Engagement Activity 2018
 
Description Oral - Impact of non-adherence on the safety and efficacy of uric acid lowering therapies in the treatment of gout. European Society for Patient Adherence, Compliance and Persistence DEC 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Oral presentation - dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Oral - Impact of non-adherence on the safety and efficacy of uric acid lowering therapies in the treatment of gout. Welsh Medicines Research Symposium 2017 (DHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Oral presentation - dissemination of research.
Year(s) Of Engagement Activity 2017
 
Description Oral - Impact of non-adherence on the safety and efficacy of uric acid lowering therapies in the treatment of gout: A PKPD simulation study. Clinical Pharmacology Colloquium 2017 (DHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners