MRC North West Hub for Trials Methodology Research

Lead Research Organisation: University of Liverpool
Department Name: Biostatistics

Abstract

The Medical Research Council funded North West Hub for Trials Methodology Research (NWHTMR) is a collaboration which brings together experts in clinical trials research from the Universities of Liverpool, Lancaster, Bangor and Manchester. Clinical trials are studies conducted in patients to evaluate the potential benefits (and risks) that new treatments could offer. They provide the 'gold standard' evidence base for informing and improving future patient care. The Hub has experts in medical statistics, clinical trials methods, pharmacoeconomics (drugs are compared for their value), sociology and clinical psychology.

The Mission of the Hub is to create a world-class centre where methods used in clinical trials can be investigated. The overall aim is to improve patient care by making sure we test, use and develop the best methods possible for clinical trials. This will help to make sure that research studies are relevant and correctly measuring what we want to measure. The Hub also works in collaboration with patients and service users to make sure their experiences of clinical trials and health conditions are included in developing better methods for carrying out clinical trials. Together we are committed to making sure that the best methods possible to design, run and analyse clinical trials are researched, developed, used and further evaluated.

The Hub focuses on four themes:
- Early phase trial design and analysis, (when drugs are first researched to check for their safety and to see what effect they have)
- Later phase trial design and analysis and (when drugs are checked to see how well they work in routine care)
- Patients' perspectives, (what patients' experiences of taking part in clinical trials are)
- Efficacy and mechanism evaluation of targeted therapies (choosing the right drug or drug dose to give to a patient, sometimes referred to as 'personalised medicine')

We want to make sure that we develop good methods that can be used in key clinical areas and we have a particular interest in drug safety, medicines for children, mental health, epilepsy, cancer, surgical trials and infection.

The major aims of the Hub are to:
- Provide a world-class environment for carrying out research that will improve the design, conduct and analysis of clinical trials;
- Make sure that our findings are used to improve the methods used in future clinical trials.
- Set up training programmes to develop the next generation of clinical trial experts.
- Work in partnership with others, both in the public sector and industry.

The key objectives are to:
- Improve the design, conduct, analysis and reporting of clinical trials;
- Develop a methodological research portfolio generated by a broad team of investigators from a range of disciplines;
- Build on considerable local Cochrane expertise to improve the integration between trials and systematic reviews in relation to trial design and reporting;
- Use local strengths in pharmacology (the study of drugs) to improve the design of drug clinical trials;
- Train the next generation of clinical trials experts;
- Work well with industry in developing good clinical trials;
- Publicise the work that we have done.

Key achievements to date include:
- The COMET (Core Outcome Measures in Effectiveness Trials) Initiative (www.comet-initiative.org) - this project works with international experts and patients interested in the development and application of agreed standardised sets of outcomes, known as 'core outcome sets'.
- The Database of Instruments for Resource Use Measurement (DIRUM www.dirum.org), (A bank of tested questionnaires for use by health economists)
- A network meeting "Improving accrual and recruitment conduct in clinical trials with children and other patients unable to consent for themselves" (http://www.liv.ac.uk/nwhtmr/events/past_events/recruit_meeting.htm.

Further details are available at http://www.liv.ac.uk/nwhtmr.

Technical Summary

The Medical Research Council funded North West Hub for Trials Methodology Research (NWHTMR) is a collaborative centre which brings together experts in biostatistics, clinical trials methodology, pharmacoeconomics, sociology and clinical psychology from the Universities of Liverpool, Lancaster, Bangor and Manchester. Our mission is to create a world-class centre where methodological issues facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the validity and relevance of the healthcare evidence base.

The Hub has four major methodological themes as follows.

(1) Early phase trial design and analysis
Early phase trials lend themselves to adaptive procedures which allow research to proceed in stages. Bayesian methods may be utilised, in which prior information is incorporated and updated by data as they accumulate. The objective of the research group is to develop, promote, and implement adaptive methods for early phase trials.

(2) Later phase trial design and analysis
Later phase, or effectiveness trials, involve particular methodological issues. The objective of this theme is to address priority topics, for example the choice of outcomes important to patients and other decision-makers, and the identification of interventions to improve recruitment and retention of participants.

(3) Patients' perspectives
This theme is focussed on three workstreams: (i) optimising patient and public involvement in trials; (ii) ensuring patient centred and effective recruitment; (iii) incorporating patient priorities in outcome measurement.

(4) Efficacy and mechanism evaluation of targeted therapies
The idea that a given medical treatment will have more benefit for some patients than for others is the underlying foundation of what is termed personalised or stratified medicine. This group will develop trial designs for stratified medicine within which evaluation of mechanism is a key feature.

Planned Impact

Who will benefit from this research?

The cross-disciplinary nature of the Hub's research portfolio and partnerships will ensure that a wide range of users will benefit from this research, including clinical trial practitioners, systematic reviewers, patients and the public, regulators, research funders, journal editors, policymakers, and methodologists.

How will they benefit from this research?

The Hub will facilitate the advancement of clinical trials methodology which will lead to improvements in, and increased efficiency of, clinical trials, leading to improvements in health care. Direct and indirect impacts for users include:

(1) Clinical trial practitioners

Hub research will generate new knowledge and innovative methodologies which will be deliberately developed to be of relevance to clinical trial practitioners who will also benefit from the Hub's training activities. The Hub will deliver highly skilled researchers in priority, scarce, multi-disciplinary areas such as health informatics, medical statistics and health economics, that will directly benefit clinical trial practitioners through the hub's advisory service, and by developing this workforce for future clinical trials.

(2) Systematic reviewers

The Hub research and training programme that focusses on improving the conduct, analysis and reporting of clinical trials has the potential to directly improve the systematic review process (e.g. disseminating recommendations on outcome reporting to clinical trialists will reduce the important problem of outcome reporting bias in systematic reviews). The hub's research will also contribute to recommendations about how best to use systematic reviews to inform clinical trial design and conduct.

(3) Patients and the public

Through implementation of recommendations of the Theme 3 Patients' Perspectives Management Group regarding best practice in patient and public engagement, the hub will generate research that will directly impact upon participants of clinical trials (e.g. the hub's work on RECRUIT project) as well as the wider patient groups for which those trial results apply. Use of innovative, more appropriate, evidence-based methods in clinical trials will lead to trial results that are more applicable (e.g. using outcomes that are relevant to patients), which will improve clinical decisions and impact on patients' quality of life, health and well-being.

(4) Research Funders

The Hub has already achieved impact with funders as the NIHR HTA and HRB Ireland guidance documents for applicants now refer to the COMET database. In addition to direct impact such as this, many of the hub's activities include a focus upon improving efficiency of clinical trials and reducing 'waste', which will lead to more appropriate, targeted, use of resources and impact research funding bodies.

(5) Journal editors

Activities within the hub portfolio that focus on research to improve the reporting of clinical trials will be of direct benefit to journal editors. Hub members are involved with international groups such as the EQUATOR Network and CONSORT, and these links will be exploited to aid dissemination.

(6) Policymakers

Through COMET we are learning how to engage with influential policymakers such as PCORI (US) and NICE (UK). Further impact is likely due to our ongoing work to compare outcomes selected for inclusion in NICE guidelines with existing core outcome sets.

Publications

10 25 50

publication icon
Grayling M (2019) A Review of Perspectives on the Use of Randomization in Phase II Oncology Trials in JNCI: Journal of the National Cancer Institute

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Hampson LV (2014) Bridging the gap: a review of dose investigations in paediatric investigation plans. in British journal of clinical pharmacology

 
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 Cochrane
Amount £119,218 (GBP)
Organisation National Institute for Health Research 
Sector Public
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Description Designing and analysing multi-arm multi-stage clinical trials with one or more endpoints
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Funding ID MR/J004979/1 
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Description HTA (COPE study, KW/CG)
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Description HTA (FEVER Trial (KW))
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Description HTA (GASTRIC Study, KW)
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Description HTA (PICnIC Trial KW)
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Description Innovative Training Network: MIROR (Methods in Research on Research)
Amount € 3,864,090 (EUR)
Funding ID H2020-MSCA-ITN-2015 
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Description MRC
Amount £171,229 (GBP)
Funding ID MR/K024310/1 
Organisation Medical Research Council (MRC) 
Sector Public
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Description MRC HTMR Network Project Award
Amount £40,830 (GBP)
Funding ID N101 
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Description MRC HTMR Network Project Funding
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Funding ID N84 
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Description MRC HTMR Network Project Funding
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Funding ID B1(2) 
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Description MRC HTMR Network Project Funding
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Funding ID N78 
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Description MRC HTMR Network Project Funding
Amount £9,817 (GBP)
Funding ID N83 
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Description MRC HTMR Network Project Funding
Amount £35,196 (GBP)
Funding ID N89 
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Description MRC MRP
Amount £501,765 (GBP)
Funding ID MR/R013748/1 torgerson 
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Description MRC MRP
Amount £345,000 (GBP)
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Description MRC MRP
Amount £367,737 (GBP)
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Description MRC Methodology Research Panel
Amount £327,080 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
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Description MRC Methodology Research Panel
Amount £49,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
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Description MRC Methodology Research Panel
Amount £42,004 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
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Description MRC Network of Hubs for Trials Methodology Research KW
Amount £41,523 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
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Description MRC Network of Hubs for Trials Methodology Research N55
Amount £14,950 (GBP)
Funding ID N55 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2014 
End 03/2016
 
Description MRC Network of Hubs for Trials Methodology Research N62
Amount £26,143 (GBP)
Funding ID N62 
Organisation Medical Research Council (MRC) 
Sector Public
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Start 06/2015 
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Description MRC Network of Hubs for Trials Methodology Research N67
Amount £7,461 (GBP)
Funding ID N67 
Organisation Medical Research Council (MRC) 
Sector Public
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Description MRC Network of Hubs for Trials Methodology Research N68
Amount £12,431 (GBP)
Funding ID N68 
Organisation Medical Research Council (MRC) 
Sector Public
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Start 10/2015 
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Description MRC PhD Studentship
Amount £168,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
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Start 01/2017 
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Description MRC PhD Studentship (AJ)
Amount £72,764 (GBP)
Organisation Medical Research Council (MRC) 
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Description MSc studentship: Genetic testing to avoid adverse drug reactions: Prioritisation strategies for commercial development (DH)
Amount £14,191 (GBP)
Organisation Government of Wales 
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Description Medical Research Council
Amount £395,000 (GBP)
Funding ID MR/L010658/1 
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Description Medical Research Council
Amount £345,000 (GBP)
Funding ID MR/M005755/1 
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Description Methodological development on biomarker cutpoint determination (TJ)
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Description NIHR EME
Amount £1,778,335 (GBP)
Organisation National Institute for Health Research 
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Description NIHR HTA
Amount £1,370,000 (GBP)
Funding ID 12/173/74 
Organisation National Institute for Health Research 
Sector Public
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Description NIHR HTA
Amount £1,536,010 (GBP)
Funding ID 12/127 
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Description NIHR HTA
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Funding ID 13/04/105 
Organisation National Institute for Health Research 
Department NIHR Biomedical Research Centre
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Description NIHR HTA (PW Co-I)
Amount £150,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
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Description NIHR Post-Doctoral Fellowship
Amount £250,433 (GBP)
Funding ID PDF-2015-08-044 
Organisation National Institute for Health Research 
Department NIHR Fellowship Programme
Sector Public
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Description NIHR Programme Grant - PGfAR CASTLE (CTS/PW)
Amount £1,957,371 (GBP)
Organisation National Institute for Health Research 
Sector Public
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Description NIHR Programme Grants for Applied Research (DH)
Amount £2,580,075 (GBP)
Organisation National Institute for Health Research 
Sector Public
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Description NIHR RMF
Amount £94,500 (GBP)
Organisation National Institute for Health Research 
Sector Public
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Description NIHR SRF
Amount £630,000 (GBP)
Organisation National Institute for Health Research 
Department NIHR Fellowship Programme
Sector Public
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Description Network of Hubs for Trials Methodology Research B1
Amount £136,000 (GBP)
Funding ID B1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2014 
End 09/2016
 
Description Network of Hubs for Trials Methodology Research B2
Amount £90,261 (GBP)
Funding ID B2 
Organisation Medical Research Council (MRC) 
Sector Public
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Start 09/2014 
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Amount £6,472 (GBP)
Funding ID R36 
Organisation Medical Research Council (MRC) 
Sector Public
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Start 06/2013 
End 04/2014
 
Description Network of Hubs for Trials Methodology Research R39
Amount £23,393 (GBP)
Funding ID R39 
Organisation Medical Research Council (MRC) 
Sector Public
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Start 10/2013 
End 09/2014
 
Description Network of Hubs for Trials Methodology Research R46
Amount £7,000 (GBP)
Funding ID R46 
Organisation Medical Research Council (MRC) 
Sector Public
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Description No choice of outcomes about us without us! Developing a video to engage patients in agreeing which outcomes are of importance for research (S Gorst and H Bagley)
Amount £1,388 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
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 Patient-centred trials: developing measures to improve the experience of people taking part in clinical trials (PB)
Amount £149,827 (GBP)
Funding ID PB-PG-0416-20033 
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description Renehan A and Williamson PR (Joint PIs). Core outcome set for anal cancer studies
Amount £229,405 (GBP)
Funding ID PB-PG-1013-32064 
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 10/2015 
End 09/2017
 
Description School for Primary Care Research Capacity
Amount £42,251 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 07/2014 
End 06/2015
 
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 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 Search for Oversight Statisticians 
Description This is a web-based system that houses a database of statisticians working in or affiliated to UKCRC registered Clinical Trials Units. The aim of the system is to: Enable identification of statisticians with experience in clinical trials as oversight committee members Support development of less experienced statisticians by providing training and mentorship opportunities as oversight committee observers 
Type Of Material Improvements to research infrastructure 
Year Produced 2016 
Provided To Others? Yes  
Impact no impact yet 
URL http://ctrc.liv.ac.uk/Tools/SOS/Home/About
 
Title The COMET Database 
Description The COMET Initiative has developed a database of all studies relevant to the development of core outcome sets for use in clinical trials. It is maintained through regular updates and an annual systematic review to make sure it contains the most up to date studies. 
Type Of Material Database/Collection of data 
Year Produced 2011 
Provided To Others? Yes  
Impact Other COS developers search this database when writing grant proposals, study protocols etc. It is also a repository of ongoing or planned work. Through this, we have successfully avoided duplication of work and facilitated international collaborations. January 2020 update: The COMET website has been redesigned with a more contemporary layout that makes better use of space. The database has also undergone changes to both the search functionality and the results display. It now uses smarter searching to allow searches to be run more easily, and the search results are displayed whereby studies that are part of the same piece of research are grouped together. 
URL http://www.comet-initiative.org/studies/search
 
Description B1(2) - Adaptive designs Outreach Officer continuation 
Organisation Lancaster University
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs.
Impact na
Start Year 2017
 
Description B1(2) - Adaptive designs Outreach Officer continuation 
Organisation University College London
Department Medical Research Council Clinical Trials Unit (MRC CTU) at UCL
Country United Kingdom 
Sector Public 
PI Contribution Network provided funding
Collaborator Contribution One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs.
Impact na
Start Year 2017
 
Description B1(2) - Adaptive designs Outreach Officer continuation 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs.
Impact na
Start Year 2017
 
Description B1(2) - Adaptive designs Outreach Officer continuation 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Network provided funding
Collaborator Contribution One of the primary objectives of the Adaptive Designs Working Group is to increase the successful implementation of adaptive design methodology in clinical trials. To achieve this aim, the ADWG started an outreach project in 2015 that offers free support for public sector researchers when embarking on an adaptive design. This application requests continuation of funding for the outreach project to develop it further and establish it as a self-funded activity at the end of this period. The project will include development of an extension to CONSORT for adaptive designs.
Impact na
Start Year 2017
 
Description 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 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 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 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 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 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
 
Title Delphi Manager 
Description DelphiManager is a web based system designed to facilitate the building and management of Delphi surveys. 
Type Of Technology Software 
Year Produced 2015 
Impact Since its development the software has been or is currently being used in 18 studies. 
URL http://cometinitiative.org/DelphiManager/
 
Description Oral Presentation - Using routinely recorded data in a UK Multicentre RCT - Assoc of British Neurologists (GP) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Conference Oral Presentation -Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description 'Trials methodology research workshop', Society for Clinical Trials, Montreal, May 2016 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination activity for trials methodology research in the UK.
Year(s) Of Engagement Activity 2016
 
Description 26th Bradford Hill Memorial Lecture (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This event was a joint venture between the London School of Hygiene and Tropical Medicine and the Royal Statistical Society allowing dissemination of research.
Year(s) Of Engagement Activity 2017
 
Description A qualitative feasibility study to inform fluids in shock (fish) - a pilot randomised controlled trial of fluid bolus therapy in septic shock, ESPINC, Lisbon (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description A qualitative feasibility study to inform fluids in shock (fish) - a pilot randomised controlled trial of fluid bolus therapy in septic shock. 30th Paediatric Intensive Care society Annual Scientific Meeting (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To raise awareness and facilitate engagement in the FiSh trial by presenting phase one qualitative findings, which involved members of the public in trial design. This won a prize for best conference presentation and led to discussions with a target journal chief editor- paper now submitted.
Year(s) Of Engagement Activity 2016
 
Description A weighted differential entropy based approach for dose-escalation trials (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
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 Annual workshop on adaptive designs and multiple comparisons procedures (TJ) 
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 Joint research and enquiries for help implementing methods
Year(s) Of Engagement Activity 2017
 
Description Association of Medical Research Charities, The COMET Initiative 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Third sector organisations
Results and Impact Raising awareness of core outcome sets and the work of the COMET initiative
Year(s) Of Engagement Activity 2016
 
Description Biomarker Guided Trials: Challenges in Practice (AJ) 
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 Identified several practical challenges of conducting biomarker-guided trials
Year(s) Of Engagement Activity 2017
 
Description Bringing democracy to Health Research: What is public and patient involvement, and why does it matter? (LB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact The presentation won the best 'shot of science' (for early career researchers), voted for by the audience
Year(s) Of Engagement Activity 2017
 
Description COMET VI conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Raising awareness of core outcome sets and the work of the COMET initiative
Year(s) Of Engagement Activity 2016
 
Description COMET VII Amsterdam 
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 115 delegates from five continents and 18 countries attended the 7th COMET meeting in Amsterdam. The event consisted of plenary talks, contributed presentations, workshops and poster presentations.
Year(s) Of Engagement Activity 2018
 
Description COMET Workshop, 23rd Cochrane Colloquium Vienna (LG) 
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 A well attended workshop with good feedback
Year(s) Of Engagement Activity 2015
 
Description COMET Workshop, Cochrane UK & Ireland symposium 2015 (LG) 
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 A well attended workshop with good feedback
Year(s) Of Engagement Activity 2015
 
Description COMET workshop, Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia, July 2016 (PW) 
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 Workshop on core outcome sets presented.
Year(s) Of Engagement Activity 2014,2016
 
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 CONTRACT Communication Study - Recruitment Training (B Young) 
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 Training staff working on the CONTRACT feasibility study in techniques to optimise trial recruitment. Clinicians fed back that the workshop was helpful in reflecting on practice.
Year(s) Of Engagement Activity 2017
 
Description CONTRACT Communication Study Preliminary Feedback (F Sherratt, B Young) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Feeding back the results of a qualitative study embedded in a trial. Clinicians fed back that the workshop was helpful in reflecting on practice.
Year(s) Of Engagement Activity 2017
 
Description CONTRACT Communication Study Preliminary Multi-site Feedback (F Sherratt, B Young) 
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 CONTRACT Communication Study Preliminary Feedback (F Sherratt, B Young) University Of Liverpool / Alder Hey NHS Foundation Trust/St Georges NHS Foundation Trust London. Feeding back the results of a qualitative study embedded in a trial to Health Care Professionals. 14/11/2017 and 21/11/2017 Clinicians fed back that the workshop was helpful in reflecting on practice
Year(s) Of Engagement Activity 2017
 
Description Children and young people support research without prior consent in life threatening situations: a qualitative study. European Academy of Paediatric Societies (EAPS), Geneva, Switzerland, 21st-25th October 2016 (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To show how children and young people support research without prior consent and encourage practitioners to engage children in critical care trial research discussions. This sparked discussion and interest in the CONNECT guidance on research without consent and showed support for the creation of an animation to help practitioners and parents inform and engage children in critical care trial discussions.
Year(s) Of Engagement Activity 2016
 
Description Children and young people's views on research without prior consent in life threatening situations: a qualitative study, PERUKI Birmingham (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Citation analysis: a new approach to assess the uptake of core outcome sets? (KB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work followed by questions.
Year(s) Of Engagement Activity 2016
 
Description Clinical Trial Design for Rare Diseases using Bayesian Bandit Models (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
Description Clinical trial recruitment and consent processes for patients without capacity:  what do we know of the perspectives of patients, carers and recruiters? (B Young) 
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 Presenting findings from studies of recruitment process for patients without capacity
Year(s) Of Engagement Activity 2017
 
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 Consent in emergency paediatric trials, UK Trial Managers Network (UKTM), London, Keynote speaker (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Core Outcome Measures in Effectiveness Trials, World Pharma Pricing and Market Access Congress 2017, London, Invited speaker (SG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Cost-effectiveness of preventing medication errors (DH) 
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 Workshop presentation
Year(s) Of Engagement Activity 2016
 
Description Deciding on the best biomarker-guided trial design: a case study (MA) 
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 at ISCB 2017 led to discussions with other attendees of the conference. Raised awareness of online tool, BiGTeD.
Year(s) Of Engagement Activity 2017
 
Description Development of a PKPD model of dual-therapy for gout to assess the impact of medication adherence on treatment success (DHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Dissemination of work. No impact yet.
Year(s) Of Engagement Activity 2016
 
Description E-trials within the UKCRC CTU Network - opportunities and challenges (DA) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Overview of E-Trials from a CTU Perspective
Year(s) Of Engagement Activity 2017
 
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 Economics of adherence (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Dissemination of work. No impact yet.
Year(s) Of Engagement Activity 2015
 
Description Engaging patients in deciding what outcomes should be measured in clinical trials (B. Young H. Bagley) 
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 Raising the profile of public participation, involvement and engagement in COS development.
Year(s) Of Engagement Activity 2017
 
Description European Federation of Pharmaceutical Industries and Associations (EFPIA), A Healthier Future: Enabling outcomes-driven sustainable healthcare 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Raising awareness of core outcome sets and the work of the COMET initiative
Year(s) Of Engagement Activity 2016
 
Description Evaluating treatment effect modification on the additive scale to investigate predictors of differential treatment response, ISCB 2017 (AM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Factorial versus multi-arm multi-stage designs in clinical trials (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
Description FiSh Study findings- presentations to collaborators 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Feedback of study results
Year(s) Of Engagement Activity 2017
 
Description Fixed and adaptive Parallel Subgroup-Specific design for survival outcomes: power and sample size (MA) 
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 led to discussions with other attendees of the workshop.
Year(s) Of Engagement Activity 2017
 
Description Generation R and the VOICES Project. RCPCH Annual Conference, Liverpool, UK, 28th April 2016 (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To present the MRC funded VOICES project aims and design with a member of our VOICES young person's advisory group. Led to interesting discussion about how children and young people can be engaged in all stages of research and what it means to be a young person involved in research.
Year(s) Of Engagement Activity 2016
 
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 Health economics for stratified medicine (2) DH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of work. No impact yet.
Year(s) Of Engagement Activity 2016
 
Description Health economics for stratified medicine (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of work. No impact yet.
Year(s) Of Engagement Activity 2016
 
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 I-DSD Copenhagen (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
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 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 ICTMC2017: How can incentives be designed and used to improve recruitment and retention in ways that are effective, efficient and ethical? (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description ICTMC2017: Priorities for methodological research on patient and public involvement in clinical trials: a modified Delphi process (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description ICTMC2017: Priority setting for core outcome set development (SG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research followed by questions.
Year(s) Of Engagement Activity 2017
 
Description ICTMC2017: Standardised taxonomy for the classification of trial outcomes within core outcome sets and Cochrane Reviews (SD) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Identifying and evaluating personalised treatment recommendations, MRC Biostatistics Unit (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Invited seminar at MRC BSU, new method being used by researchers there and interactions based on talk
Year(s) Of Engagement Activity 2017
 
Description Improving Design, Evaluation and Analysis of Early Drug Development Studies (IDEAS) (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
Description International approaches to consent seeking in pediatric critical care trials: the views of parents and healthcare providers. The 8th World Congress of the World Federation of Pediatric Intensive & Critical Care Societies (PICC), Toronto, Ontario, Canada, June 4-8 2016 (KW) 
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 Poster to help engage international health care practitioners in our work around research without prior consent. Led to new connections/twitter followers.
Year(s) Of Engagement Activity 2016
 
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 Know what to know - Some guidance for efficient experimental and clinical study design (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
Description Multi-objective dose-finding, Vienna (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description NIHR E-Studies 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description NWHTMR Showcase meeting June 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 Presentations showcasing the outputs of the NWHTMR including questions and discussion from the audience.
Year(s) Of Engagement Activity 2018
 
Description New approaches to longitudinal causal mediation analysis, SAMS conference (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Optimal multi-arm multi-stage designs (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
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 - Clinical Trial to Real-World Evidence: Enabling the Shift to Value-based Decisions -Washington DC (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Invited, Oral Presentation. American Society for Clinical Pharmacology and Therapeutics, Washington DC, March 2017 Dyfrig Hughes, Bangor University. Paper submitted to Clinical and Translational Science (CTS) entitled: "Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care"
Year(s) Of Engagement Activity 2016,2017
 
Description Oral Presentation - Confidence Regions for Treatment Effects in Biomarker Stratified Designs. California, USA 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Oral Conference Presentation - dissemination of research. 10th International Conference on Multiple Comparison Procedures. Riverside, California, US, July 2017. Thomas Jaki, Lancaster University
Year(s) Of Engagement Activity 2017
 
Description Oral Presentation - Health economics of stratified medicine - UK 2017 (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Invited, 4th Annual Open Meeting. UK Pharmacogenetics and Stratified Medicine Workshop, March 2017 Oral Presentation. Dyfrig Hughes Bangor University
Year(s) Of Engagement Activity 2017
 
Description Oral Presentation - Improving Design, Evaluation and Analysis of Early Drug Development Studies (IDEAS) -London (TJ) 
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. PSI 1-Day Scientific Meeting - Translational Statistics: Ideas-Evidence-Innovate-Communicate, London, UK, March 2017.Dissemination of research. Thomas Jaki, Lancaster University.
Year(s) Of Engagement Activity 2017
 
Description Oral presentation - Assessing the impact of a funder's recommendation to consider core outcome sets in funding applications - COMET VII (KH) 
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 at COMET VII conference followed by questions.
Year(s) Of Engagement Activity 2018
 
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 - ICTMC 2017 Patient preferences for outcomes in clinical trials: implications for medicines optimisation (DH/EH) 
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 at ICTMC 2017, May 2017 Liverpool UK Emily Holmes and Dyfrig Hughes, Bangor 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 Oral presentation - Optimal Designs for Non Compartmental Analysis of Pharmacokinetics - CEN-ISBS conference 2017 (TJ) 
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 CEN-ISBS conference August 2017Joint Conference on Biometrics & Biopharmaceutical Statistics. Dissemination of research. Thomas Jaki Lancaster University 2017
Year(s) Of Engagement Activity 2017
 
Description PACT workshop, Manchester 2014 (PB) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 20 participants knowledge exchange and identification of future methodological research to improve patient experience of trials

Links with INVOLVE
Year(s) Of Engagement Activity 2014
 
Description PERSPECTIVES Consent to research (KP) 
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 and discussion of methods and procedure with delegates
Year(s) Of Engagement Activity 2017
 
Description Patient and parent reported outcomes in juvenile idiopathic arthritis 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Feeding back the results of a qualitative study to inform a consensus meeting. The purpose of the consensus meeting was to decide upon a core outcome for a feasibilty study.
Year(s) Of Engagement Activity 2017
 
Description Patient preferences for outcomes in clinical trials: implications for medicines optimisation - MHRA 2017 (EH/DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Oral presentation Medicines and Healthcare Regulatory Authority, Jan 2017. Emily Holmes, Dyfrig Hughes, Bangor University
Year(s) Of Engagement Activity 2017
 
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 Presentation - ICTMC 2017 - Rituximab for the treatment of Neuromyelitis Optica (NMO): an application of individual patient data meta-analysis in a rare disease (SB/DH) 
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 ICTMC 2017 May 2017 Liverpool UK. Siobhan Bourke, Dyfrig Hughes. Bangor University.
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 Poster presentation BPS - Children & Young People Support Research Without Prior Consent in Life Threatening Situations: A Qualitative Study (LR) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation BPS - Children & Young Peoples' Experience of Acute & Chronic Illness: A Qualitative Study (LR) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC 2017 Patient-level information and costing systems (PLICS) as a source of routinely collected cost data for trial-based economic evaluations (CR/DH) 
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 ICTMC 2017, May 2017 Liverpool UK. Colin Ridyard, Dyfrig Hughes. Bangor University. Dissemination of research.
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - 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 Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - A systematic search of ClinicalTrials.gov to assess the uptake of core outcome sets (JK) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Biomarker-guided clinical trial designs: Sample size calculations with survival endpoints (MA) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Children & Young People Support Research Without Prior Consent in Life Threatening Situations: A Qualitative Study (LR) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Collating the evidence base to facilitate patient and public involvement in core outcome set development - a qualitative meta-synthesis (LB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Design and analysis of the learning curve and clustering effects in randomised surgical trials - a review of current practice (EC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Evaluating personalised treatment recommendations using randomised controlled trials (MP) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Evaluating treatment effect modification on the additive scale for the evaluation of predictive markers (AM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Family perspectives on the feasibility of a corticosteroid induction regimen randomised controlled trial in juvenile idiopathic arthritis: Results of a qualitative study. (FS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Identifying effective retention strategies: A research agenda (AK) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Online resource for Recruitment Research in Clinical triAls research (ORRCA) (AK) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Outcome selection in clinical trials - looking back at the problems and moving forward with solutions (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - 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 Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Reducing attrition: The communication of retention and withdrawal within Patient Information Sheets (AK) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Reported reasons for missing data (AK) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017 - Site training to improve healthcare practitioners' confidence in recruiting to a challenging critical care trial (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation ICTMC2017- Assessing the impact of a funder's recommendation on consideration and uptake of core outcome sets in funding applications (KB) 
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 ICTMC2017 conference led to discussion about PhD project with other delegates
Year(s) Of Engagement Activity 2017
 
Description Poster presentation NW Rheumatology Club - Families' perspectives on the feasibility of a corticosteroid induction regimen randomised controlled trial in juvenile idiopathic arthritis: results from qualitative interviews (FS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Poster presentation Paediatric Rheumatology Congress - Families' views on the feasibility of a corticosteroid trial in JIA: a qualitative study (FS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description Precision Medicine - Addressing the Key Challenges of Demonstrating Clinical Utility (AJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A session organised for the ICTMC2017 conference 3 other invited speakers from the world of stratified medicine. We had active discussion both between us as speakers and with the audience. Raised awareness of our online tool, BiGTeD.
Year(s) Of Engagement Activity 2017
 
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 Prioritising measures that matter: initial observations and plans on developing core outcome sets with patients (B. Young, S Gorst) 
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 Feeding back findings from qualitative study on investigators' experiences of COS development.
Year(s) Of Engagement Activity 2017
 
Description ROAM Information Study (F Sherratt, B Young) 
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 ROAM Information Study (F Sherratt, B Young) University of Liverpool/London 27/11/2017 Feeding back the results of a qualitative study embedded in a trial. Clinicians fed back that the workshop was helpful in reflecting on practice
Year(s) Of Engagement Activity 2017
 
Description ROAM Information Study (F Sherratt, B Young) 
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 Feeding back the results of a qualitative study embedded in a trial. Clinicians fed back that the workshop was helpful in reflecting on practice.
Year(s) Of Engagement Activity 2017
 
Description ROAM Trial Investigators Communication Training Meeting (F Sherratt, B Young) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Feeding back the results of a qualitative study embedded in a trial
Year(s) Of Engagement Activity 2017
 
Description SAMS Conference July 2017, Poster Presentation. Adjusting for treatment changes in epilepsy trials: a comparison of causal methods for survival outcomes (SD) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description SIRJIA Steering Group Meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Feeding back the results of the qualitative study to inform future directions in the feasibility study. The results will be used to inform the development of the feasibility study.
Year(s) Of Engagement Activity 2017
 
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
 
Description TAILoR: Lessons from a multi-arm multi-stage clinical trial in HIV/AIDS (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of work
Year(s) Of Engagement Activity 2016
 
Description Talk NWHTMR Improving health by improving trials April 2014 (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub

NA
Year(s) Of Engagement Activity 2014
 
Description Talk, 16th Annual J&J Pharma Statistics Conference (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


Discussions about implementation of method with Janssen Pharmaceutica
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


Discussions about implementation of method with a CRO
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (AC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Wider dissemination of work

None
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (WYY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, 36th Society for Clinical Trials Conference 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


NA
Year(s) Of Engagement Activity 2015
 
Description Talk, 5th Annual Summit for Clinical Ops Executives 2014 (AHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Dicussion

No notable impacts
Year(s) Of Engagement Activity 2014
 
Description Talk, 8th Annual optimising clinical trials summit (AHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research

NA
Year(s) Of Engagement Activity 2014
 
Description Talk, Aberdeen 2014 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Australian Biometric Society conference, Hobart, 1st December 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Overview of research on stratified medicine
Year(s) Of Engagement Activity 2015
 
Description Talk, Australian Pharmaceutical Biostatisticians Group, Sydney, 7th December 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Overview of research on causal inference
Year(s) Of Engagement Activity 2015
 
Description Talk, British Society for Hematology 2015 (AJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of findings of EU-PACT, a biomarker guided trial
Year(s) Of Engagement Activity 2015
 
Description Talk, CTMC Edinburgh 2014 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Questions and discussion with other academics


Future research and publications planned
Year(s) Of Engagement Activity 2014
 
Description Talk, Centre for Biostatistics, Melbourne, 26th November 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of research and promotion of related papers
Year(s) Of Engagement Activity 2015
 
Description Talk, Centre of Excellence for Public Health, Queen's University Belfast, 27th September 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Overview of research on stratified medicine
Year(s) Of Engagement Activity 2015
 
Description Talk, Faculty for Oncology and Palliative Care Meeting 2014 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Unknown at this point
Year(s) Of Engagement Activity 2014
 
Description Talk, Florence 2014 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Germany 2014 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, GlaxoSmithKline 2014 (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Planned progression to collaborative project


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, HTMR Network Meeting, Bristol, 27th January 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Overview of research on stratified medicine
Year(s) Of Engagement Activity 2015
 
Description Talk, ICTMC, Glasgow, 17th November 2015 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of latest findings of NWHTMR Theme 4 research
Year(s) Of Engagement Activity 2015
 
Description Talk, Institute Gustave-Roussy 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Wider dissemination of work

Developed a collaboration with Dr Marie-Cecile Le Deley which has culminated in joint supervision of a PhD student who started in October 2014 and is developing novel Bayesian designs for clinical trials in rare cancers
Year(s) Of Engagement Activity 2014
 
Description Talk, Institute for Translational Medicine Research Day 2015 (AJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Increasing profile of research group of Hub network; initiating new collaborations with researchers
Year(s) Of Engagement Activity 2015
 
Description Talk, Institute of Population Health Postgraduate showcase 2014 (AHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion

Not aware of any notable impacts
Year(s) Of Engagement Activity 2014
 
Description Talk, Joint meeting of Danish and Swedish societies for biopharmaceutical/medical statistics 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None
Year(s) Of Engagement Activity 2014
 
Description Talk, MRC/NIHR Methods Fellows Meeting 2014 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion with audience about MRC career's options, and stratified medicine research


Collaboration with Newcastle around methodology work
Year(s) Of Engagement Activity 2014
 
Description Talk, Manchester 2014 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Education and training

Change in practice in attendants
Year(s) Of Engagement Activity 2014
 
Description Talk, Mini Symposium on alternative methods for dose-finding and dose-ranging trials 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


Has led to Merck adopting a model based approach to dose finding for the first time
Year(s) Of Engagement Activity 2015
 
Description Talk, NWCTC meeting, Manchester (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Discussion

Potential recruits for the START project
Year(s) Of Engagement Activity 2014
 
Description Talk, NWHTMR Research day 'Improving Trials by Improving Trials for Patients 2015 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Raising profile of NWHTMR
Year(s) Of Engagement Activity 2015
 
Description Talk, NWHTMR Research day 'Improving Trials by Improving Trials for Patients' 2015 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Raising profile of NWHTMR
Year(s) Of Engagement Activity 2015
 
Description Talk, Novartis internal statistics seminar series 2014 (SS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None
Year(s) Of Engagement Activity 2014
 
Description Talk, Oxford 2014 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Pfizer 2014 (DH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Collaborator for studentship


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Prevention Science Methodology Group 2014 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Interaction with international researchers in mediation analysis


Discussions about future publications
Year(s) Of Engagement Activity 2014
 
Description Talk, RCPCH Annual Conference 2015 (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of CONNECT study guidance on deferred consent for critical care trials

NA
Year(s) Of Engagement Activity 2015
 
Description Talk, SMi Conference on Adaptive designs in Clinical Trials 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Wider dissemination of work to the pharmaceutical industry

None
Year(s) Of Engagement Activity 2014
 
Description Talk, Scottish Primary Care Network meeting 2015 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Raising profile of NWHTMR
Year(s) Of Engagement Activity 2015
 
Description Talk, Symposium on Early Phase Dose Finding Methodology 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


NA
Year(s) Of Engagement Activity 2015
 
Description Talk, University of Newcastle 2015 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Dissemination of Hub research particularly EPIC study
Year(s) Of Engagement Activity 2015
 
Description The feasibility and acceptability of the fluids in shock (fish) trial - perspectives of parents and site staff involved in the fish pilot trial, Peadiatric Intensive Care Society Conference, Nottingham (KW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Dissemination of research
Year(s) Of Engagement Activity 2017
 
Description UK parents report agreeing to paediatric intensive and critical care trial to help other children in the future. The 8th World Congress of the World Federation of Pediatric Intensive & Critical Care Societies (PICC), Toronto, Ontario, Canada, 4-8th June 2016 (KW) 
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 Poster to help engage international health care practitioners in our work around research without prior consent. Led to new connections/twitter followers.
Year(s) Of Engagement Activity 2016
 
Description Uncertainty and examples of reimbursement issues with accelerated release of drugs (DH) 
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 Workshop presentation
Year(s) Of Engagement Activity 2016
 
Description Using patient-important outcomes for systematic reviews: A joint Cochrane and COMET (Core Outcome Measures in Effectiveness Trials) workshop (S Gorst, H Bagley) 
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 Raising the profile of public participation, involvement and engagement in COS development. Blog post on Cochrane Community Blog.
Year(s) Of Engagement Activity 2017
 
Description Virtual Presentation to HRB Trials Methodology Research Network 2015 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Raising profile of NWHTMR
Year(s) Of Engagement Activity 2015
 
Description Virtual Presentation to University of Edinburgh MSc in Clinical Trials 2015 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Raising profile of NWHTMR and learning for students

Raising profile of NWHTMR
Year(s) Of Engagement Activity 2015
 
Description Webinar - PSI Toxicology Special Interest Group, December 2017. Optimal Designs for Non Compartmental Analysis of Pharmacokinetics (TJ) 
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 The PSI Special Interest Group "Toxicology" have a series of regular webinars dealing with statistical topics faced in toxicology and related fields. The presentations run for an hour, with approximately 45 min presentation and a Q&A session in the remaining time. Dissemination of research, Thomas Jaki Lancaster University 12 December 2017.
Year(s) Of Engagement Activity 2017
 
Description Webinar. (K Woolfall) Research priorities for Patient and Public Involvement in trials. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Webinar of METHODICAL Study findings
Year(s) Of Engagement Activity 2017
 
Description Weighting clinical trial outcomes by patients' preferences: a case study in epilepsy (EH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Dissemination of work. No impact yet.
Year(s) Of Engagement Activity 2016
 
Description Workshop Approaches to deferred consent in the EcLiPSE trial February 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Training on how recruitment and consent should be sought in the EcLiPSE trial, which included a video and evidence based recommendation on how deferred consent should be sought.

Before the session clinicians voiced concerns about recruitment to the trial due to the use of deferred consent. After the session clinicians were more supportive of the approach to recruitment and consent. The training video was described as a useful tool.
Year(s) Of Engagement Activity 2015
 
Description Workshop on methods for core outcome set development, London, January 2016 (PW) 
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 facilitate discussion on the methods to use when developing a core outcome set.
Year(s) Of Engagement Activity 2016
 
Description Workshop, Nuffield Council on Bioethics 2014 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Discussion of wide range of ethical, methodological, PPI and practical issues related to children's research worldwide

Nuffield Council report due April 2015
Year(s) Of Engagement Activity 2014