MRC Clinical Trials Unit as the London Hub for Trials Methodology Research

Lead Research Organisation: University College London

Abstract

Methodology is the science of how to do things. It underpins the design, conduct and analysis of clinical trials. The aim of this proposal is to improve this methodology, give better trials leading ultimately to better outcomes for patients.

Technical Summary

The MRC CTU vision is to integrate methodological research within the development, execution, analysis and reporting of trials. The trials themselves pose methodological problems and in turn, the methodological work results in new and better ways of designing, conducting and analysing trials. Our methodological research will initially be focussed in areas where we already have established expertise and experience. We shall also respond to new methodological questions as they arise, and as time and priorities permit.

Organisations

Publications

10 25 50

publication icon
Choodari-Oskooei B (2015) The extension of total gain (TG) statistic in survival models: properties and applications. in BMC medical research methodology

 
Title Induction Pack for PPI (Public Patient Involvement) Contributorson Trial Oversight Committees 
Description A guidance pack to help researchers design relevant PPI for their trial 
Type Of Material Improvements to research infrastructure 
Year Produced 2018 
Provided To Others? Yes  
Impact None yet 
URL https://www.ctu.mrc.ac.uk/media/1416/induction_pack_for_ppi_contributors_on_trial_oversight_committe...
 
Description Cochrane IPD Synthesis Working Group 
Organisation Brown University
Country United States 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation Keele University
Country United Kingdom 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation Queen's University Belfast
Country United Kingdom 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation Radboud University Nijmegen
Country Netherlands 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University Medical Center Utrecht (UMC)
Country Netherlands 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University of Hasselt
Department International Drug Development Institute
Country Belgium 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University of Sydney
Country Australia 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description Cochrane IPD Synthesis Working Group 
Organisation University of York
Department Centre for Reviews and Dissemination (CRD)
Country United Kingdom 
Sector Academic/University 
PI Contribution Participated in teleconference discussions and preparation of the final report
Collaborator Contribution Participated in teleconference discussions and preparation of the final report
Impact Cochrane IPD Synthesis Working Group Report
Start Year 2017
 
Description HDR London (Health Data Research, London) 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Lead the London bid for the trials component, one of five active sites in London
Collaborator Contribution Active in HDR UK team for London sites
Impact None yet
Start Year 2018
 
Description HDR London (Health Data Research, London) 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Lead the London bid for the trials component, one of five active sites in London
Collaborator Contribution Active in HDR UK team for London sites
Impact None yet
Start Year 2018
 
Description HDR London (Health Data Research, London) 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Lead the London bid for the trials component, one of five active sites in London
Collaborator Contribution Active in HDR UK team for London sites
Impact None yet
Start Year 2018
 
Description HDR London (Health Data Research, London) 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Lead the London bid for the trials component, one of five active sites in London
Collaborator Contribution Active in HDR UK team for London sites
Impact None yet
Start Year 2018
 
Description HDR UK (Health Data Research, UK) 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution Unit is part of HDR UK, which is a new UK-wide partnership investigating how health research can be improved through access to routine and study-specific health data
Collaborator Contribution Led the London-wide bid for trials activity. Actively contributing to other areas.
Impact None yet
Start Year 2018
 
Description Honorary contract with EMA 
Organisation European Medicines Agency
Country United Kingdom 
Sector Public 
PI Contribution Accessing information at the EMA to inform design and conduct of trials to ensure they are better positioned for future licensing applications
Collaborator Contribution Providing access to the EMA documents and databases
Impact Not yet. PhD chapter in development
Start Year 2018
 
Description ORCCA2 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Screening of abstracts to form the database for this project
Collaborator Contribution Initating and management of this project
Impact None yet
Start Year 2018
 
Description Partnership with HRA, MHRA and NCRAS/PHE for source data verification project 
Organisation Medicines and Healthcare Regulatory Agency
Department General Practice Research Database (GPRD)
Country United Kingdom 
Sector Academic/University 
PI Contribution MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data.
Collaborator Contribution The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful.
Impact None so far
Start Year 2017
 
Description Partnership with HRA, MHRA and NCRAS/PHE for source data verification project 
Organisation NHS Health Research Authority
Country United Kingdom 
Sector Public 
PI Contribution MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data.
Collaborator Contribution The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful.
Impact None so far
Start Year 2017
 
Description Partnership with HRA, MHRA and NCRAS/PHE for source data verification project 
Organisation National Cancer Registration and Analysis Service
Country United Kingdom 
Sector Public 
PI Contribution MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data.
Collaborator Contribution The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful.
Impact None so far
Start Year 2017
 
Description Protocol for systematic review of trial monitoring 
Organisation University of Basel
Country Switzerland 
Sector Academic/University 
PI Contribution Assitance and input to plans to develop a Protocol
Collaborator Contribution Assitance and input to plans to develop a Protocol
Impact Not yet
Start Year 2018
 
Description Routine electronic health records (EHR) used as trial data by randomised controlled trials in the UK 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of a Protocol for a systematic review, undertaking review activities and manuscript preparation
Collaborator Contribution Guidance and advice on the development of the Protocol, assistance with review activities
Impact Published Protocol at url above
Start Year 2018
 
Description Routine electronic health records (EHR) used as trial data by randomised controlled trials in the UK 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of a Protocol for a systematic review, undertaking review activities and manuscript preparation
Collaborator Contribution Guidance and advice on the development of the Protocol, assistance with review activities
Impact Published Protocol at url above
Start Year 2018
 
Description Show RESPECT study collaboration 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Leading Show RESPECT study, looking at best ways to disseminate study results to study participants
Collaborator Contribution Members of steering group, helping to design, conduct and disseminate results of study
Impact None yet
Start Year 2017
 
Description Show RESPECT study collaboration 
Organisation Harvard University
Department Harvard Medical School
Country United States 
Sector Academic/University 
PI Contribution Leading Show RESPECT study, looking at best ways to disseminate study results to study participants
Collaborator Contribution Members of steering group, helping to design, conduct and disseminate results of study
Impact None yet
Start Year 2017
 
Description Show RESPECT study collaboration 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Leading Show RESPECT study, looking at best ways to disseminate study results to study participants
Collaborator Contribution Members of steering group, helping to design, conduct and disseminate results of study
Impact None yet
Start Year 2017
 
Description Show RESPECT study collaboration 
Organisation NHS Health Research Authority
Country United Kingdom 
Sector Public 
PI Contribution Leading Show RESPECT study, looking at best ways to disseminate study results to study participants
Collaborator Contribution Members of steering group, helping to design, conduct and disseminate results of study
Impact None yet
Start Year 2017
 
Description Show RESPECT study collaboration 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution Leading Show RESPECT study, looking at best ways to disseminate study results to study participants
Collaborator Contribution Members of steering group, helping to design, conduct and disseminate results of study
Impact None yet
Start Year 2017
 
Description TEMPER-related collaboration 
Organisation University College Cork
Country Ireland 
Sector Academic/University 
PI Contribution Coordinating two pieces of work related to (extensions of) the TEMPER monitoring study (run from MRC CTU at UCL, funded by CRUK and MRC)
Collaborator Contribution PhD student at Cork, helping plan, conduct and analyse the two small projects.
Impact None yet
Start Year 2017
 
Description Trials methodology research partnership 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Collaborator Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Impact None yet
Start Year 2018
 
Description Trials methodology research partnership 
Organisation The Global Health Network
Country Global 
Sector Charity/Non Profit 
PI Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Collaborator Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Impact None yet
Start Year 2018
 
Description Trials methodology research partnership 
Organisation UK Trial Managers Network
Sector Academic/University 
PI Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Collaborator Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Impact None yet
Start Year 2018
 
Description Trials methodology research partnership 
Organisation UKCRC Registered trials CTU network
Country United Kingdom 
Sector Academic/University 
PI Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Collaborator Contribution Key member of the executive group, designed and formed the network, oversight, provision of PhD student, courses
Impact None yet
Start Year 2018
 
Description Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution Guidance on study protocol, application for data access
Collaborator Contribution Supervision of PhD, data analysis
Impact Not yet
Start Year 2017
 
Description Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Guidance on study protocol, application for data access
Collaborator Contribution Supervision of PhD, data analysis
Impact Not yet
Start Year 2017
 
Description Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) 
Organisation University of Warwick
Country United Kingdom 
Sector Academic/University 
PI Contribution Guidance on study protocol, application for data access
Collaborator Contribution Supervision of PhD, data analysis
Impact Not yet
Start Year 2017
 
Title Show RESPECT 
Description The Show RESPECT study is aiming to find practical ways to share the results of clinical trials with the people taking part in it. It is doing this by testing several different approaches within a large ovarian cancer trial (the ICON8 trial). 
Type Products with applications outside of medicine
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2018
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Nil 
URL http://www.isrctn.com/ISRCTN96189403
 
Description PPI Induction Pack development workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact A workshop to develop a PPI package
Year(s) Of Engagement Activity 2018