Renewal of the Network of Hubs for Trials Methodology Research.

Lead Research Organisation: University of Liverpool
Department Name: Biostatistics

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.

Publications

10 25 50

 
Description Benefit-Risk Assessment to Inform Non-Inferiority and Superiority study design (BRAINS)
Amount £49,853 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2018 
End 04/2020
 
Description Costing Adaptive Trials (CAT): developing best practice for CTUs supporting adaptive trials
Amount £55,629 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 10/2019 
End 10/2021
 
Description Designing and analysing multi-arm multi-stage clinical trials with one or more endpoints
Amount £443,152 (GBP)
Funding ID MR/J004979/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 09/2012 
End 06/2016
 
Description Developing efficient perpetual platform trials to study multiple treatments and multiple biomarkers
Amount £228,041 (GBP)
Funding ID MR/N028171/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 02/2017 
End 01/2020
 
Description MRC HTMR Network Project Award
Amount £40,830 (GBP)
Funding ID N101 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 02/2018 
End 01/2019
 
Description MRC MRP
Amount £501,765 (GBP)
Funding ID MR/R013748/1 torgerson 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start  
 
Description Patient-centred trials: developing measures to improve the experience of people taking part in clinical trials
Amount £149,827 (GBP)
Funding ID PB-PG-0416-20033 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 02/2018 
End 07/2019
 
Description Trials Methodology Research Partnership
Amount £458,666 (GBP)
Funding ID MR/S014357/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 06/2019 
End 05/2022
 
Description What is the value of adaptive designs? Estimating expected value of sample information for adaptive trial designs.
Amount £510,646 (GBP)
Funding ID MR/S036709/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start  
End 12/2022
 
Title BiGTeD 
Description To improve the understanding of the various biomarker-guided trial designs and provide valuable and much-needed guidance on their implementation we are developing a user-friendly online tool (www.BiGTeD.org). BiGTeD provides an easily accessible resource to inform on the most optimal design when embarking on a biomarker-guided trial including easy to navigate graphical displays of the various trial designs. An overview of each design's key characteristics, methodology, and pros and cons is provided. Knowledge on how to design, implement and analyse these trials is essential for testing the effectiveness of a biomarker-guided approach to treatment. 
Type Of Material Improvements to research infrastructure 
Year Produced 2016 
Provided To Others? Yes  
Impact no impact yet 
URL http://www.bigted.org/
 
Title COMET Handbook 
Description Online publically available repository of core outcome sets, kept uptodate 
Type Of Material Improvements to research infrastructure 
Year Produced 2012 
Provided To Others? Yes  
Impact Recommendations to use this research tool by multiple organisations including NIHR, NICE, and many others - see http://www.comet-initiative.org/cosuptake 
URL http://www.comet-initiative.org/
 
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
 
Description Adaptive Designs TMRP working group 
Organisation Lancaster University
Country United Kingdom 
Sector Academic/University 
PI Contribution NA
Collaborator Contribution The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge).
Impact tbc
Start Year 2019
 
Description Adaptive Designs TMRP working group 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution NA
Collaborator Contribution The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge).
Impact tbc
Start Year 2019
 
Description Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects.
Impact tbc
Start Year 2019
 
Description Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects.
Impact tbc
Start Year 2019
 
Description Impact N104: Building on success: a workshop to synthesise learning on patient and public involvement from a portfolio of MRC Hub projects 
Organisation University of Manchester
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution Patient Public Involvement (PPI) remains fundamental to high quality applied research, and there is increasing guidance on effective methods, as well as new NIHR standards. However, the application of PPI in methodology research brings new challenges, and it is critical that learning from PPI in this field is captured and shared to promote good practice. The transition from the MRC HTMR network to the MCR-NIHR TMRP provides an excellent opportunity to synthesise learning from a selection of patient-oriented projects with a variety of PPI methods funded in the MRC HTMR network. We propose a workshop including teams from a range of projects funded within HTMR. This will include METHODICAL study (R62), PACT (R46), and additional projects led by collaborators on the new TMRP and facilitated through the HTMR (PRIORITY I & II) together with PPI contributors from those teams and from relevant external organisations. These will be strengthened with social media chats and dialogue on specific issues. We will consider the role and impact of PPI using the new definition in each of the invited projects, and undertake small group breakout work to map the PPI to existing frameworks, highlight challenges and identify potential solutions. We will develop guidance and principles for enhancing effective PPI in methodology projects.
Impact tbc
Start Year 2019
 
Description N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this.
Impact tba
Start Year 2017
 
Description N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this.
Impact tba
Start Year 2017
 
Description N100 Improving the evaluation of medical devices with development of a generic core outcome set (COS): a key stakeholder workshop. 
Organisation West of England Academic Health Science Network
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution The development of drugs follows a clear well-regulated pathway. In contrast, surgical devices often receive regulatory approval and adoption based on poorly reported studies of low quality. Once released it is uncommon for well-designed and conducted early/later phase studies to take place. The IDEAL Collaboration set out guiding principles (stages) for surgical devices but hasn't been adopted. The MRC (HTMRs) have recognised the flaws associated with current reporting of surgical trials and devices. A significant challenge in the evaluation of all phases of surgical device development is outcome reporting. Numerous outcomes are reported, making data synthesis difficult and risking outcome reporting bias. RCTs have methodologically improved in part due to the development of COSs. However, these have focused on specific conditions and/or surgical procedures. The COMET database provides details of COSs that have been developed or are under development. At present, there are no COS specifically developed to aid earlier and later phase studies on innovative surgical technologies and devices. Consequently, it is difficult for stakeholders to compare key outcomes. Adverse events may be under reported (reporting bias) or ill-defined. It is therefore difficult to judge whether to proceed to full evaluation or abandon new technology. The proposed workshop is intended for the first time to bring together key stakeholders in the development and evaluation of surgical technologies and devices to consider mandated core outcome reporting. It will describe the current problem with outcome reporting in this field and the pitfalls, present COSs as a solution to this problem to use from early to later phase trials and consider methods for live outcome reporting in registries and on-line journals to optimise learning. The workshop will establish whether it will be feasible to develop a generic COS for the reporting of all surgical devices and establish next steps to achieve this.
Impact tba
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation Health Research Board (HRB)
Country Ireland 
Sector Public 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation Medical Research Council (MRC)
Department MRC Clinical Trials Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N101 ORRCA and Extending ORRCA to create a central resource for retention research within clinical trials (ORRCA 2) 
Organisation University of Manchester
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided funding
Collaborator Contribution Background: Recruitment and retention challenges are well documented and have been identified as key methodological research priorities by UK CTUs. Whilst this focus has led to an increase in the quantity of research directed at these challenges, evidence for effective interventions is limited and navigating the literature to identify strategies relevant to different types of trials remains difficult. The flagship output from the HTMR recruitment working group was the launch of an online searchable database of recruitment research in 2016, helping trialists to identify interventions and areas for future methodological research. Project delivery engaged 24 researchers from 7 institutions and 3 countries. 1139 users from 18 countries have undertaken 1061 searches during the first nine months. The database is currently being updated with 2015-2016 publications (completion Nov 2017). However, no such resource exists for retention research. Retention may be influenced by recruitment methods but this aspect is often unexplored. We will develop ORRCA2 to organise and map retention research, linking with ORRCA to explore connections and overlap between recruitment and retention research. Methods: Search strategies for major databases will be adapted from the Cochrane Methodology Review of retention interventions. Eligible studies will include retention strategy evaluations, descriptive studies identifying risk factors, qualitative research and relevant case reports. Articles exploring treatment adherence or statistical methods for handling missing data will be excluded. Outputs: A matrix of retention research domains and a searchable database will be developed as per ORRCA. A mapping exercise will explore current methodological research topics and the potential to evaluate recruitment and retention simultaneously outcomes in future SWATs or nested randomised studies. Text mining methodology will be explored to increase sustainability of ORRCA and ORRCA 2.
Impact N/A
Start Year 2017
 
Description N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel.
Impact na
Start Year 2019
 
Description N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel.
Impact na
Start Year 2019
 
Description N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel.
Impact na
Start Year 2019
 
Description N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel.
Impact na
Start Year 2019
 
Description N102 Impact award Defining the remit and setting the scope for the new Trial Conduct Working Group: opportunities for transformation under the partnership 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Under the Trials Methodology Research Partnership (TMRP) the new Trial Conduct Working Group (TCWG) is the only working group whose membership will change significantly. This involves the merging of two existing, effective, working groups, the current Trial Conduct Working Group and the Recruitment Working Group (RWG). To date, these groups have largely worked independently and their merger will provide an opportunity to encourage and promote collaboration both internally in the WG and externally in the TMRP and beyond. We believe that an initial face to face meeting is key to forge new relationships and collaborations within the new TCWG and encourage all members to have buy-in and commitment to the group . We propose a one day workshop to discuss and agree the remit and scope of the TCWG and identify core activities relevant for trial conduct (including areas for research and opportunities for development of other outputs such as 'good practice' documents) that reflect the priorities of the multidisciplinary group. This event will facilitate a smooth transition to the new WG structure and continue the legacy of the previous RWG and TCWG. Active members of the current groups will be invited to attend. Individuals interested in joining the TCWG can submit a request to attend but may be asked to fund their own travel.
Impact na
Start Year 2019
 
Description N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations.
Impact na
Start Year 2019
 
Description N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations.
Impact na
Start Year 2019
 
Description N103 Impact award Evaluation of digital health interventions: workshop and "Issues to consider" document 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution n/a
Collaborator Contribution A recent systematic review of randomised trials of online interventions demonstrates a growing trend over time (Figure 1) (1). A random sample of 100 of these trials suggests that online interventions are most commonly used for health promotion (42%) or mental health issues (32%); however, the remaining 26% of trials covered an additional 14 clinical areas, including cancer (4%), diabetes (3%) and neurology (3%). More broadly, digital health interventions (DHI) can present distinct advantages over traditional interventions in certain clinical settings, including increased accessibility, convenience and value for money. However, given that DHI involve not only medicine but also behaviour, computing and engineering, their evaluation presents particular challenges which may not be adequately addressed using conventional biomedical methods, such as randomised trials. Trials are useful for providing evidence for a drug or therapy where the format does not change over time; however, DHI may need to be continuously updated in order to meet changing demands relating to software compatibility, evidence-based content and the "look and feel" of the intervention. As such, a trial may provide initial underlying evidence of the effectiveness of a DHI, but evidence of its continuing usefulness in light of changing digital environments over time will need to be obtained using iterative methods more commonly employed in engineering than medicine (2). Health economic assessments of DHI also differ from those required for typical drug interventions, for example, because of the need to allow funding for the continued evolution of DHI after the trial, as well as the atypical economies of scale, with high fixed costs and low cost per user, and the common uncertainty about what to treat as "sunk" costs. Measuring participant engagement with DHIs also requires special consideration; various methods exist but their reliability is not guaranteed. Public Health England have successfully created an evaluation toolkit which presents a workable practical approach to evaluate such interventions (3,4). Implementation of such methods by UKCRC registered Clinical Trials Units (CTUs) is not likely to be straightforward, however, given the need to use unfamiliar research methods which are not typically included in clinical evaluations. Funds are requested to cover the costs of hosting a workshop (to be held in November/December 2019) for CTU statisticians, information system developers, health economists, chief investigators and a funder representative to discuss the issues when evaluating DHI. Participation will be restricted to those with experience of designing, running and analysing DHI trials. This workshop will include presentations from proposed keynote speakers (including S Dodd to present findings from the systematic review of online intervention trials, and the REACT trial exemplar*; E Murray to discuss methodological issues; K Karpathakis, Digital Strategy Lead from Public Health England to explain approach used by PHE to evaluate DHI; health economist Caroline Clarke from UCL or James Raftery from Southampton), followed by an open discussion to identify the practical demands of carrying out such evaluations.
Impact na
Start Year 2019
 
Description N105 Impact award Practicalities in running trials with more than one primary hypothesis and an adaptive element (Platform trials 
Organisation University College London
Department Medical Research Council Clinical Trials Unit (MRC CTU) at UCL
Country United Kingdom 
Sector Public 
PI Contribution na
Collaborator Contribution With the help of funding from the Trial Conduct Working Group we ran a day discussing the practicalities of running platform trials (defined as trials with more than one primary hypothesis and an adaptive element). We invited 27 statisticians, trial managers and Chief investigators from 21 platform trials in a structured day with a different attendee leading each of the 15 sessions. The discussion has been written up in a paper form by 15 different authors. We would like an editor with 5 years experience in editing such papers to make the paper speak with one voice. To do this we would need to pay for her time. There would be more work from Sharon Love after this edit to finalise changes and then another round of reviews from the authors
Impact na a publication is expected
Start Year 2019
 
Description 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 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 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 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 N87 - Advancing the integration of mixed methods in clinical trials: a two day summit 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice.
Impact na
Start Year 2017
 
Description N87 - Advancing the integration of mixed methods in clinical trials: a two day summit 
Organisation University of Exeter
Department Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice.
Impact na
Start Year 2017
 
Description N87 - Advancing the integration of mixed methods in clinical trials: a two day summit 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Up to twenty experts in mixed methods and clinical trials will attend a two day summit on the integration of qualitative and quantitative methods in RCTs. Day one will involve presentation and facilitated discussion leading to an authoritative overview of the current strengths and weaknesses in the integration of mixed methods in clinical trials. On day two, attendees will identify the next steps required to provide the trials community with guidance on integration. Project outputs will comprise (i) an open access position paper on integration in clinical trials and (ii) an application to the MRC Methodology Research Programme in June 2017 for funds to develop guidance. By convening the summit, the HTMR will help equip the trials community with new skills and techniques in the integration of quantitative and qualitative methods that can be applied by researchers in their own practice.
Impact na
Start Year 2017
 
Description N89 - Improving the efficiency of biomarker-guided trial designs by using continuous biomarker information. 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Biomarkers are increasingly being identified that have the potential to predict how well patients will respond to a treatment. The ultimate aim is to measure the biomarker in clinical practice and use the results to stratify patients, treating them differently depending on the stratum they are in. However, whilst genetic biomarkers with their typically categorical nature lend themselves easily to the idea of stratification, it is not so clear how continuous biomarkers should be used in this way. In addition, before implementing a biomarker to guide treatment in clinical practice, the effectiveness of the biomarker guided approach to treatment must be demonstrated, typically in the form of a biomarker guided trial. However, the design of such trials typically assumes dichotomisation of the biomarker, which loses substantial statistical efficiency. It is unclear how continuous biomarkers should be incorporated and at what stage of the clinical development process the biomarker information should be dichotomised. In this project we propose to review methodologies for determining how to optimally stratify patients using continuous biomarkers, both in the context of a single biomarker and where a panel of biomarkers are predictive, as well as considering at what timepoint during the biomarker's development this decision should be made. The methodologies used in the evidence base for biomarkers already recommended for clinical use will also be investigated. Based on this work we will be able to provide guidance for researchers on the most suitable approach to use. We will also aim to identify gaps in methodology that future work can address.
Impact na
Start Year 2017
 
Description N89 - Improving the efficiency of biomarker-guided trial designs by using continuous biomarker information. 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Biomarkers are increasingly being identified that have the potential to predict how well patients will respond to a treatment. The ultimate aim is to measure the biomarker in clinical practice and use the results to stratify patients, treating them differently depending on the stratum they are in. However, whilst genetic biomarkers with their typically categorical nature lend themselves easily to the idea of stratification, it is not so clear how continuous biomarkers should be used in this way. In addition, before implementing a biomarker to guide treatment in clinical practice, the effectiveness of the biomarker guided approach to treatment must be demonstrated, typically in the form of a biomarker guided trial. However, the design of such trials typically assumes dichotomisation of the biomarker, which loses substantial statistical efficiency. It is unclear how continuous biomarkers should be incorporated and at what stage of the clinical development process the biomarker information should be dichotomised. In this project we propose to review methodologies for determining how to optimally stratify patients using continuous biomarkers, both in the context of a single biomarker and where a panel of biomarkers are predictive, as well as considering at what timepoint during the biomarker's development this decision should be made. The methodologies used in the evidence base for biomarkers already recommended for clinical use will also be investigated. Based on this work we will be able to provide guidance for researchers on the most suitable approach to use. We will also aim to identify gaps in methodology that future work can address.
Impact na
Start Year 2017
 
Description N90 - Developing CONSORT guidance for adaptive clinical trials 
Organisation Lancaster University
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research.
Impact na
Start Year 2017
 
Description N90 - Developing CONSORT guidance for adaptive clinical trials 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research.
Impact na
Start Year 2017
 
Description N90 - Developing CONSORT guidance for adaptive clinical trials 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Adaptive designs allow changes to be made to a trial based on data gathered during it. This can provide substantial benefits including increased efficiency and ethics. However they are also more complicated than traditional designs. Thus reporting of trials using an adaptive design is difficult, leading to concerns about interpretability and reproducibility of adaptive trials that may hamper their uptake in practice. Previous work has identified the need for reporting guidelines for trials using adaptive designs. The CONSORT guidance framework has substantially improved the reporting of randomised controlled trials. However, there is no guidance tailored for the reporting of adaptive trials. This proposal is part of a larger project that will develop and disseminate a CONSORT extension for adaptive trials. This proposal will improve the quality and international impact of the developed guidance through three activities. The first is a consensus workshop that will bring together around 30 multidisciplinary experts in adaptive trials from around the world. The workshop participants will consist of representatives from academia, industry and regulatory agencies. By including international representatives in person (rather than via telephone), we believe the developed guidance will be of much higher quality and more relevant to a worldwide audience. The second is a dissemination workshop that will present the guidance to a UK audience. We will invite around 60 individuals that represent a variety of stakeholders including medical journal editors, academic trialists and industry representatives. The third is to present the guidance at the SCT conference in 2018, which will help disseminate the guidance beyond the UK. We expect the development of the guidance to raise important gaps in methodology that need to be addressed. Thus, the dissemination workshop will also involve discussions to identify these. In the longer term we hope that this may lead to additional useful methodology research.
Impact na
Start Year 2017
 
Description N91 - Health Economics Analysis Plans: developing content guidance through consensus 
Organisation Bangor University
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely.
Impact na
Start Year 2017
 
Description N91 - Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely.
Impact na
Start Year 2017
 
Description N91 - Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely.
Impact na
Start Year 2017
 
Description N91 - Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution Aims To identify the key content and develop a template for health economic analysis plans that will guide analysts in conducting economic evaluations alongside randomised controlled trials (RCTs). Background The use of SAPs, drawn up in advance of the analysis phase of a trial, is an accepted means of reducing bias in reporting the results of RCTs. However, while health economic analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance. In October 2015, an HTMR-funded workshop involving fifty (predominantly academic) participants was held to discuss some of the issues associated with HEAPs. Feedback from the workshop suggested that health economists would value guidance and clarity on the appropriate content of a HEAP. Methods Building on recent work led by the NW Hub to create guidance for SAPs, we propose to develop a template for a HEAP. We plan to use 'real time' Delphi methodology, which involves presenting dynamic feedback to participants, to gain a consensus opinion on the relevant content of a HEAP. A literature review will identify published HEAPs and additional examples will be sought from practising health economists in order to derive a list of items for inclusion in an electronic Delphi survey. A panel of experts will be recruited and, after seeding the survey with responses from randomly selected attendees of the workshop, the survey will be opened to the panel for a period of one month. The project team will convene at the end of the survey to discuss the results with invited participants in a consensus meeting. The final list of items will be developed into a template HEAP, which will be disseminated widely.
Impact na
Start Year 2017
 
Description N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus 
Organisation Bangor University
Department Centre for Health Economics and Medicines Evaluation
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation.
Impact No impact yet
Start Year 2018
 
Description N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation.
Impact No impact yet
Start Year 2018
 
Description N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation.
Impact No impact yet
Start Year 2018
 
Description N91 Impact award Health Economics Analysis Plans: developing content guidance through consensus 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution An economic evaluation conducted alongside a randomised controlled trial (RCT) aims to establish the value for money that a given intervention represents. The cost-effectiveness results are at risk of bias if researchers do not report all the results, or conduct post hoc analyses without labelling them as such. Pre-specifying the planned analyses by means of a health economics analysis plan (HEAP) can reduce the risk of bias, and allow decision makers to have confidence in the results. However, there is little guidance available to help researchers write a HEAP. A well-attended Hub-funded workshop on HEAPs (held in October 2015) established that there is a need for guidance on the appropriate content of HEAPs. The original HEAPs project therefore aimed to derive a consensus position on the items that should be included in a HEAP. Delphi consensus methodology was employed: two rounds of questionnaires and a final item selection meeting allowed us to identify 58 essential items and 9 optional items that should be considered when preparing a HEAP. This list is currently being piloted in trials at an appropriate stage, and a template is in preparation. We propose to run a training workshop to introduce the HEAPs template to an audience of health economists actively engaged in conducting economic evaluations alongside RCTs. The training event will place the HEAP within the framework of trial documentation (including the protocol and statistical analysis plan), and will provide a hands-on introduction to implementing the template. This will increase the impact of the template by providing guidance at an early stage of its implementation.
Impact No impact yet
Start Year 2018
 
Description N96 Covariate adjustment in randomised trials 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding.
Collaborator Contribution Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial.
Impact N/A
Start Year 2017
 
Description N96 Covariate adjustment in randomised trials 
Organisation Medical Research Council (MRC)
Department MRC Clinical Trials Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding.
Collaborator Contribution Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial.
Impact N/A
Start Year 2017
 
Description N96 Covariate adjustment in randomised trials 
Organisation University of Manchester
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding.
Collaborator Contribution Randomised trials typically involve collecting pre-randomisation information about key demographic and clinical characteristics of participants. Randomisation of treatment ensures that participants in the different arms of the trial are comparable, which means that an unadjusted comparison of outcomes between arms provides an unbiased estimate of the treatment effect. However, adjusting for pre-randomisation measurements within a regression model may increase the statistical power. Whether an adjusted or unadjusted analysis should be performed as the primary analysis remains a contentious issue. Current guidelines regarding the optimal way to incorporate covariates into the primary analysis of randomised trials recommend including a limited number of pre-specified covariates, and explicitly recommend against data-adaptive model selection procedures and including interactions between treatment and covariates into the model. However, some theoretical work suggests that data-adaptive approaches may have benefits, and including interactions can help protect against model misspecification. Further, most of the theoretical work underpinning guidelines is based on continuous outcome measures, but many randomised trials have time-to-event outcomes. The aim of the proposed work is to re-analyse a small number of published trials, using a range of covariate-adjustment analysis strategies, focusing particularly on time-to-event outcomes, in order to explore the benefits and limitations of each approach. Key issues uncovered will be subsequently explored in simulation studies. We aim to provide practical guidance to trialists regarding the optimal way to account for baseline covariates in the primary analysis of a randomised trial.
Impact N/A
Start Year 2017
 
Description N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. 
Organisation Lancaster University
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner.
Impact N/A
Start Year 2017
 
Description N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner.
Impact N/A
Start Year 2017
 
Description N97 Investigating the reasoning behind the use of non-randomised single-arm designs in phase II clinical trials. 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Network Provided Funding
Collaborator Contribution Classically, single-arm trial designs have been the standard approach in oncology research for conducting a phase II clinical trial. In recent years however, acknowledgement of the limitations associated with single-arm studies has seen an increased call for the use of randomisation in phase II. Indeed, numerous discussion articles have now put forward arguments for and against the use of single-arm designs in this setting, and several simulation studies have been conducted to try to identify which approach should be preferred. At the very least, these presentations together indicated that the percentage of phase II trials using randomisation should increase. Nonetheless, a large number of phase II trials continue to be conducted using single-arm designs, with a contemporary review indicating at least 50% of UK Clinical Trial Units (CTUs) had recently been involved in such a study (Jaki 2013, Clin Trials 10:344-46). Therefore, it is possible that the design of many publicly funded trials remains sub-optimal for a reason that could easily be rectified. Accordingly, in this project, we will first circulate a questionnaire to each of the CTUs within the UKCRC Registered CTU Network, with the aim of establishing key factors behind their choice to utilise either a single-arm or randomised approach in any phase II clinical trials they have been involved in. Following the completion of this survey, amongst those expressing interest, the CTUs responsible for conducting the largest number of phase II trials will be visited for more in-depth follow-up meetings. Finally, the results of these discussions will, in combination with the expertise of several researchers, aid the development of a guidance document on the recommended contemporary design of phase II trials. This document should be of great value to the trials community for helping ensure future phase II trials are designed in the most appropriate manner.
Impact N/A
Start Year 2017
 
Description 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 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 - 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 R1 COMET Impact Award 
Organisation Queen's University Belfast
Department MRC All-Ireland Methodology Hub
Country United Kingdom 
Sector Academic/University 
PI Contribution HTMR Network Provided Funding £9100.
Collaborator Contribution This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group
Impact No Impact yet.
Start Year 2018
 
Description R1 COMET Impact Award 
Organisation University of Bristol
Department School of Social and Community Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution HTMR Network Provided Funding £9100.
Collaborator Contribution This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group
Impact No Impact yet.
Start Year 2018
 
Description R1 COMET Impact Award 
Organisation University of Liverpool
Department MRC Methodology Hub
Country United Kingdom 
Sector Academic/University 
PI Contribution HTMR Network Provided Funding £9100.
Collaborator Contribution This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group
Impact No Impact yet.
Start Year 2018
 
Description R1 COMET Impact Award 
Organisation University of Oxford
Department School of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution HTMR Network Provided Funding £9100.
Collaborator Contribution This impact project will build on the original work by creating a network of LMIC researchers with an interest in COS development and application. Raising awareness and sharing ideas and experiences should start a dialogue to determine how COMET can support the development and application of COS in LMICs. To achieve this, we propose to offer bursaries to researchers from LMICs to attend and participate in COMET VII. We propose building on COMET's links to Cochrane, by inviting Cochrane Centre Directors and leads from China, South Asia, Brasil and Africa. We should like to invite five LMIC researchers from the various groups in these regions. Specific objectives of this proposal are to raise awareness about the importance of COS development and application, discuss issues of generalisability of COS in relation to LMICs, and develop a strategy for COMET to support the development, dissemination and use of COS in LMICs. The partner representatives form the COMET Initiative Management Group
Impact No Impact yet.
Start Year 2018
 
Description R44 Impact award Development of Guidance for Statistical Analysis Plans for Clinical Trials. 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution na
Collaborator Contribution Increasing calls for transparency, reproducibility and data sharing within clinical trials have led to a greater emphasis on the early development and publication of robust Statistical Analysis Plans (SAPs). Funded by the HTMR, a minimum set of items for SAPs was agreed following an extensive and iterative development process involving funders, regulatory authorities, journals and researchers to address a marked variation in practice. The subsequent publication in JAMA was supported by an editorial piece and has been cited 36 times in the last 18 months according to google scholar, highlighting the international importance of this research. The guidance is now widely used within UK registered CTU Standard Operating Procedures and is listed within the EQUATOR website, the Clinical Trials Toolkit and the Global Health Network resources. In addition, multiple international requests have been made for a downloadable checklist to be made available, based on the contents list, in a similar manner to CONSORT etc. A number of ongoing initiatives demonstrate the relevance of the SAP work, but also the failure of it to be included or cited. For example, the FDA require 'appropriate statistical content' to be made publically available alongside the results of clinical trials, but they fail to define what this entails. Data sharing policies from the Wellcome Trust and the NIHR also fail to cite the guidance. In addition, SAPs continue to be published in the supplementary material of journals, or are requested as part of the submission process but not used. Journals do not provide any guidance to their reviewers on what they should expect with regards to the SAPs they are being provided as part of peer review. Funding is requested for a research assistant from 1st August to 31st December at 0.2FTE to maximise the impact of the SAP Work by: • Creating a downloadable version of the SAP checklist from a dedicated website as well as the EQUATOR website. The development of a small dedicated website will place the guidance in line with similar pieces of work (e.g. PRISMA, CONSORT) and will allow tracking of key metrics (visitors and downloads) to measure impact. This resource will be disseminated via social media, newsletters and emails to CTUs, network partners, funders, journals and regulatory agencies. • Challenging funders of clinical trials (e.g. Wellcome Trust, NIHR) to request SAPS alongside protocols to ensure pre-specification of statistical analysis plans within the public domain. They will also be encouraged to cite the SAP checklist and use it as an assessment tool within funding awards and data sharing policies. • Lobbying the FDA to cite the guidance when defining 'appropriate' statistical content within the National Institutes of Health Final Rule for Clinical Trials Registration and Results Information Submission. • Challenging journals (e.g. Trials, Clinical Trials, JAMA) to recommend publication of SAPs either as a stand alone publication or alongside protocols, using the checklist as a peer review assessment tool. We plan to utilise existing contacts within key organisation made during the SAP project as well as new connections made through the newly formed MRC-NIHR TMRP to deliver this.
Impact na
Start Year 2019
 
Description 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 The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
Description The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
Description The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation The Global Health Network
Country Global 
Sector Charity/Non Profit 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
Description The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation Trials Methodology Research Network
Country Ireland 
Sector Private 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
Description The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation UK Trial Managers Network
Sector Academic/University 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
Description The MRC-NIHR Trials Methodology Research Partnership - Partners 
Organisation UKCRC Registered trials CTU network
Country United Kingdom 
Sector Academic/University 
PI Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network.
Collaborator Contribution The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee.
Impact TBC
Start Year 2019
 
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 5th International Clinical Trial Methodology Conference Oct 6-9th 2019 
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 5th International Clinical Trial Methodology Conference Oct 6-9th 2019 was a three day meeting with an international audience of trialists, clinical researchers, representatives from industry and patient groups. A large spectrum of research was demonstrated orally and via posters - some of which was funded by the HTMR Network.
Year(s) Of Engagement Activity 2019
 
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 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 COMET VII - The COMET Initiative's seventh international meeting 
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 COMET VII meeting in Amsterdam - 1.5 day meeting - included invited talks, contributed talks and 45 posters.

Onehundred and fifteen participants gathered from around the world, coming from five continents and 18 countries. COMET was awarded an MRC HTMR Impact Award to support the attendance of and participation of several researchers from low and middleincome countries (LMIC) at COMET VII. Four participants successfully joined COMET VII, which included researchers from Brazil, India, and
Year(s) Of Engagement Activity 2018
URL http://www.comet-initiative.org/events/SeventhCometMeeting
 
Description COMETVII 2018 Oral presentation: Assessing the impact of a funder's recommendation on consideration and uptake of core outcome sets in funding applications. (KH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Conference abstract (oral presentation at COMETVII 2018):
Karen L Hughes, Jamie J Kirkham, Mike Clarke, Paula R Williamson. Assessing the impact of a funder's recommendation on consideration and uptake of core outcome sets in funding applications. Journal of Evidence-Based Medicine 2019, Volume 12, Issue S1
Year(s) Of Engagement Activity 2018
 
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 Conference Abstract 2019 PTH-115 Variation in assessment of outcomes for IBD in routine clinical practice: an ethnographic study.VR 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Razanskaite V, Young B, Williamson P, et al. PTH-115 Variation in assessment of outcomes for ibd in routine clinical practice: an ethnographic study. Gut 2019;68:A91-A92.
Year(s) Of Engagement Activity 2019
 
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 ESPA COMP Conference Poster 2018 Potential effectiveness and pricing of future xanthine oxidase inhibitors for gout (DMH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact • European Society for Patient Adherence, Compliance and Persistence (ESPACOMP) Dublin, 2018 (poster presentation)
Potential effectiveness and pricing of future xanthine oxidase inhibitors for gout: Pharmacometric and pharmacoeconomic simulations using real-world medication adherence data. Daniel Hill-McManus, Elena Soto, Scott Marshall,
Year(s) Of Engagement Activity 2018
 
Description Exhibition stand for ICTMC 2019 - representing HTMR Network and TMRP 
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 GC covered a stand at ICTMC 2019 promoting and disseminating information regarding HTMR Network research and the launch of TMRP
Year(s) Of Engagement Activity 2019
 
Description Exhibition stand for Liverpool Clinical Trial Reseach Unit and SPARK Launch day 231019 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Promotion and dissemination of HTMR Network and TMRP to a wide audience interested in clinical trials - with various levels of experience executing clinical trials - verbally and with hand out
Year(s) Of Engagement Activity 2019
 
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 Health Economics Analysis Plans workshop 14th February 2019 Bristol and 9th October 2019 at ICTMC 2019 in Brighton 
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 Workshop to disseminate Health Economics Analysis Plans research funded by HTMR Network award
Year(s) Of Engagement Activity 2019
 
Description How to be a Good Chief Investigator Workshop 
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 A full training day to provide guidance to newly funded chief investigators in relation into different perspectives of running a trial. CPD approved.
Year(s) Of Engagement Activity 2019
URL https://www.methodologyhubs.mrc.ac.uk/files/3815/5975/3113/Flyer_-_How_to_be_a_good_CI_workshop_Nov_...
 
Description ICTMC 2019 Oral Clinical trial simulation and value of information to optimise design of clinical trials from a pharmaceutical industry perspective (DMH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact • International Clinical Trials Methodology Conference (ICTMC) Brighton, 2019 (Oral presentation)
Clinical trial simulation and value of information to optimise design of clinical trials from a pharmaceutical industry perspective
Year(s) Of Engagement Activity 2019
 
Description ICTMC 2019 Oral Exploring the barriers and facilitators to core outcome set (COS) uptake: assessing the impact of a funder's recommendation to use COS followed by qualitative interviews with clinical trialists (KH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Conference abstract (Oral presentation at ICTMC 2019):
Exploring the barriers and facilitators to core outcome set (COS) uptake: assessing the impact of a funder's recommendation to use COS followed by qualitative interviews with clinical trialists
Karen L Hughes1, Bridget Young1, Mike Clarke2, Jamie Kirkham1, Paula RWilliamson1 Trials2019,20(Suppl 1):PS5D
Year(s) Of Engagement Activity 2019
 
Description ICTMC 2019 Poster Assessment of outcomes for inflammatory bowel disease in routine clinical practice: an ethnographic study. (VR) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Poster presentation at ICTMC 2019 HTMR funded PhD VR
Year(s) Of Engagement Activity 2019
 
Description ICTMC 2019 Poster The MRC HTMR recruitment working group: Driving recruitment research through collaboration 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact The MRC HTMR recruitment working group: Driving recruitment research through
collaboration
Introduction: The Hubs for Trials Methodology Research (HTMR) were set up by the UK Medical
Research Council (MRC) in 2009 to create a UK-wide resource to improve the design, conduct,
analysis, interpretation, and reporting of clinical trials. Collaborations and networking were fostered
through working groups focusing on key priority areas for the UK trials community.
Methods: The remit of the Recruitment Working Group (RWG) is to develop, implement, and
evaluate recruitment interventions in clinical trials and promote/cultivate new ideas and studies to
improve the efficiency of recruitment research through collaboration.
Potential relevance and impact: Two landmark studies in recruitment research were reported in
2017, specifically the ORRCA online resource for recruitment research (a RWG collaborative project)
and the PRioRiTy study that identified the top ten questions for recruitment research. These, along
with systematic review evidence, were discussed by 20 RWG members, in a face-to-face meeting,
and future RWG activities prioritised.
Three key research areas were identified by the RWG: the core information needs of clinical trial
participants (PRioRiTy question 5), core training activities for health professionals working on a
clinical trial (PRioRity question 6), and the inclusion of under-represented/minority groups within
clinical trials (PRioRity question 8).
Sub-working groups for each of the three research questions have been established representing
cross HTMR collaboration. Research proposals are in development that will address the research
questions prioritised by the RWG and to develop SWAT protocols for future evaluation across
multiple trials. The RWG has enabled a collaborative, innovative, cohesive, efficient network of
researchers interested in trials methodology consolidating efforts to achieve more than the sum of
the parts and built a solid foundation for future growth and expansion as the network develops.
Year(s) Of Engagement Activity 2019
 
Description ICTMC 2019 Poster presentation: P85: A discrete choice experiment to measure public preferences for genetic testing to prevent adverse drug reactions (DJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact ICTMC 2019, poster presentation 'P-85: A discrete choice experiment to measure public preferences for genetic testing to prevent adverse drug reactions
Danielle Johnson
Year(s) Of Engagement Activity 2019
 
Description ICTMC 2019 presentation Essential items for a Health Economics Analysis Plan (HEAP): expert Delphi consensus survey 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Thorn JC, Davies CF, Brookes ST, Dritsaki M, Gray E, Hughes D, Noble SM, Petrou S, Ridyard C, Sach T, Wilson E, Mihaylova B, Wordsworth S and Hollingworth W. Essential items for a Health Economics Analysis Plan (HEAP): expert Delphi consensus survey for presentation at 5th International Clinical Trials Methodology Conference, 6th - 9th October 2019.
Year(s) Of Engagement Activity 2019
 
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 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 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
Results and Impact Oral presentation - dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Oral presentation - ICTMC 2017 - Using routinely recorded data in a clinical trial: the feasibility, agreement and additional benefits compared to standard prospective data collection methods (GP) 
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 - ICTMC 2017 - May 2017 - Liverpool, UK. Graham Powell. Liverpool University.
Year(s) Of Engagement Activity 2017
 
Description Oral presentation - Impact of non-adherence on the safety and efficacy of uric acid lowering therapies in the treatment of gout - Budapest (DHM/DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact European Society for Patient Adherence, Compliance and Persistence, Budapest, Nov 2017. Daniel Hill-McManus and Dyfrig Hughes. Bangor University. Dissemination of Research
Year(s) Of Engagement Activity 2017
 
Description PIRRIST: A patient and public involvement (PPI) intervention to enhance recruitment and retention in surgical trials. Crocker et al. 
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 at IDEAL Conference, Bristol, 2018. Published in International Journal of Surgery 2018; 59, Supplement 1: S-S2, #3.

Crocker JC, Rees S, Locock L, Petit-Zeman S, Chant A, Treweek S, Cook JA, Farrar N, Woolfall K, Bostock J, Harmston R, Ferrey A, Bulbulia R. PIRRIST: A patient and public involvement (PPI) intervention to enhance recruitment and retention in surgical trials.
Year(s) Of Engagement Activity 2018
 
Description Poster - Biomarker Guided Trial Designs ("BiGTeD"): An online tool to help develop personalised medicine - MEMTAB 2018 (AJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Presentation of poster followed by discussion
Year(s) Of Engagement Activity 2018
 
Description Poster - Biomarker Guided Trial Designs (BiGTeD): An online tool to help develop personalised medicine - PGRN-American society for Human Genetics joint symposium 2018 (AJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation of poster followed by discussion
Year(s) Of Engagement Activity 2018
 
Description Poster - Evidence to justify inclusion of biomarkers in randomised controlled trials - Liverpool National Student Research Conference 2018 (DJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Presentation of poster followed by discussion
Year(s) Of Engagement Activity 2018
 
Description Poster - ICTMC 2017 A systematic review of core outcomes for Crohn's disease in adults. (HC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Poster Presentation at ICTMC 2017: Catt H, Bodger K, Hughes D, Kirkham J. A systematic review of core outcomes for Crohn's disease in adults. Poster presented at: 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials; 07-10 May 2017; Liverpool, UK. Trials 2017, 18 (Suppl 1):P291.
Year(s) Of Engagement Activity 2017
 
Description Poster Presentation ICTMC 17 Quantitative benefit-risk modelling of infliximab biosimilar Inflectra versus reference product Remicade in the treatment of Crohn's disease. (HC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Poster Presentation at the ICTMC 2017 Conference Catt H, Hughes D, Bodger K, Kirkham J. Quantitative benefit-risk modelling of infliximab biosimilar Inflectra versus reference product Remicade in the treatment of Crohn's disease. Poster presented at: 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials; 07-10 May 2017; Liverpool, UK. Trials 2017, 18 (Suppl 1):P143.
Year(s) Of Engagement Activity 2017
 
Description Poster presentation - Evidence to justify inclusion of biomarkers in randomised controlled trials - MEMTAB 2018 (DJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Poster presentation followed by discussion at MEMTAB 2018 by NWHTMR PhD student
Year(s) Of Engagement Activity 2018
 
Description Presentation - The ORRCA database: An online research database supporting evidence-based trial recruitment management. ACTA International Clinical Trials Conference. Sydney, Australia 2019. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Conference presentation: Bracken K, Kearney A, Harman NL, Gamble C. The ORRCA database: An online research database supporting evidence-based trial recruitment management. ACTA International Clinical Trials Conference. Sydney, Australia 2019.
Year(s) Of Engagement Activity 2019
 
Description Statistical Analysis Plans- for transparency, reproducibility, data sharing, reducing waste in research. REWARD EQUATOR conference. Berlin 2020 (PW) 
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 Williamson P.R, Gamble C, Kearney A. Statistical Analysis Plans- for transparency, reproducibility, data sharing, reducing waste in research. REWARD EQUATOR conference. Berlin 2020
Year(s) Of Engagement Activity 2020