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

Lead Research Organisation: MRC Clinical Trials Unit

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
Ahmed HU (2014) Can we deliver randomized trials of focal therapy in prostate cancer? in Nature reviews. Clinical oncology
Altman DG (2009) Prognosis and prognostic research: validating a prognostic model. in BMJ (Clinical research ed.)
Bartlett JW (2014) Improving upon the efficiency of complete case analysis when covariates are MNAR. in Biostatistics (Oxford, England)
 
Description Citation in a new FDA guidance document
Geographic Reach North America 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm269919.pdf
 
Description IDMC guidance for research ethics committees
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description INVOLVE guidance for researchers on patient and public involvement in clinical trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing Data sharing: Data Transparency and data sharing: an academic CTU perspective. Presentation at PSI annual conference
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing analysis of CTU-led and other cohort studies: Modelling association between patient characteristics and change over time in a disease measurement
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing analysis of data in meta-analysis: Analysis of treatment by patient covariate interactions in meta-analysis
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Use of this method has become standard in MRCCTU-led meta-analysis of IPD and has also been applied in MRC CTU meta-anlayses of aggregate data. The method has also been used to analyse subgroup interactions in IPD meta-analyses at the Institute Gustav Roussy (France). It has also been presented at national and international conferences
 
Description Influencing analysis of survey and trial data: Multiple imputation and inverse probability weighting
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing clinical guidelines: NICE consultation for new guidelines on sleeping of newborn infants
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing practice relating to dropout from longitudinal clinical trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact Research on reference based sensitivity analyses for longiudianl clincal trials with dropout is continuing to influence practice. A Drug information workking group discussion is hosted on the website of a senior member of CTU statistical methodology staff (James Carpenter) and the methodology has been used in a number of regulatory submissions from companies
URL http://www.missingdata.org.uk
 
Description Influencing statistical anlaysis of clinical trials: restricted mean survival times to analyse trials with non-proportional hazards (Add Aspirin)
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing statistical practice: Multiple Imputation and its Application
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing trial analysis: Comparison of dynamic treatment regimes/monitoring strategies (DART)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
URL http://europepmc.org/abstract/MED/20347483
 
Description Influencing trial analysis: Estimating the effect of time-varying treatment (ARROW trial)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
URL http://europepmc.org/abstract/MED/20347483
 
Description Influencing trial analysis: Use of Restricted Mean Survival Time method in CTU-led clinical trials (ICON7)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing trial analysis: Use of flexible parametric survival analysis in CTU-led cancer clinical trials (ASTEC)
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www.amazon.co.uk/Flexible-Parametric-Survival-Analysis-Using/dp/1597180793/ref=sr_1_1?s=books...
 
Description Influencing trial design: Use of ART in CTU-led and other clinical trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing trial design: Use of MAMS design in CTU-led and other clinical trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing trial design: Use of TAMS design in CTU-led clinical trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing trial design: Use of biomarker designs in CTU-led cancer clinical trials (FOCUS4)
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing understanding of clinical trial designs: MAMs trials presentation at network HTMR PhD students meeting
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing understanding of statisics for clinical trials: IDMCs presentation at the EORTC staistics for non statistician course
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing understanding of statistics for clinical trials: IDMCs presentation, FLIMs 2014 Course
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing understanding of statistics for clinical trials: Presentation at the Yorkshire Mens Health Forum
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Influencing understanding of statistics for clinical trials: Software for sample size calculations. A presentation at the FLIMs 2014 course
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Joint project risk-adapted guidance
Geographic Reach National 
Policy Influence Type Citation in other policy documents
 
Description Methodological Expectations of Cochrane Intervention Reviews: Searching for Studies
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Multi-arm multi-stage randomised controlled trials: an adaptive design: A statistical seminar at the Royal Free Hospital
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Statistical design of phase III trials: A presesntation at the All Ireland Cooperative Oncology Group Conference
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Workshop and guidance on IPD meta-analysis
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
 
Description Workshop on mult-arm mult-stage (MAMS) trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description CR UK Population Science Committee, Project Grant (TEMPER study)
Amount £205,540 (GBP)
Funding ID C1495/A13305 
Organisation Cancer Research UK (CRUK) 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 05/2012 
End 05/2016
 
Description Cross-Unit Appointment: Strategies to reduce attrition in RCTS
Amount £106,500 (GBP)
Organisation Medical Research Council (MRC) 
Department Population Health Sciences Research Network (PHSRN)
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Cross-Unit Appointment: Using causal analyses to add value to large RCTs
Amount £185,000 (GBP)
Organisation Medical Research Council (MRC) 
Department Population Health Sciences Research Network (PHSRN)
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 04/2014 
 
Description MRC HTMR Network award
Amount £136,000 (GBP)
Funding ID HTMR B1 
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 03/2014 
End 02/2016
 
Description MRC HTMR Network award- Adaptive Design Outreach officer
Amount £136,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 03/2014 
End 02/2016
 
Description MRC Hub for Trials Methodology Research (HTMR) - extension
Amount £500,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 04/2014 
End 03/2014
 
Description NIHR Fellowship: Analysis of recurrent events in clinical trials
Amount £100,000 (GBP)
Organisation University College London Hospitals Charity (UCLH) 
Department National Institute for Health Research (NIHR)
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 09/2013 
End 08/2016
 
Description Workshops, small projects, other Hub events:The use of individual participant data (IPD) in systematic reviews
Amount £23,260 (GBP)
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Title ART sample size software 
Description Stata software to calculate required sample size for trials with time-to-event outcomes 
Type Of Material Improvements to research infrastructure 
Year Produced 2007 
Provided To Others? Yes  
Impact This software is freely available and is now the standard tool for sample size calculation both at the MRC Clinical Trials Unit and at other units. Currently, further developments include extedning the software for clinical trials with binary outcomes. 
 
Title Analysis of patient subgroup interactions in IPDMA: STATA software 
Description STATA code 
Type Of Material Improvements to research infrastructure 
Year Produced 2011 
Provided To Others? Yes  
Impact Has allowed this improved methodolgy to analyse patient subgroup interactions to be implemented in IPD meta-analysis. 
 
Title Flexible parametric survival modelling: STATA stpm software and updates 
Description STATA software 
Type Of Material Improvements to research infrastructure 
Year Produced 2009 
Provided To Others? Yes  
Impact Facilitates flexible parametric survival modelling using STATA. Software is available to download from the publicly available Statistical Software Compnents (SSC) arvhive from where it has been downloaded in the region of 100 times per month since late 2012 
 
Title MAMS trial design: STATA nstage software 
Description STATA software. Currently being further developed for different outcomes types (i.e. trials with binary outcomes) and also for use in other statistical packages (e.g. R) 
Type Of Material Improvements to research infrastructure 
Year Produced 2009 
Provided To Others? Yes  
Impact Aids in the design of MAMS trials. Access to this sotfware facilitates the design and implementation of such trial designs by others. 
 
Title STATA CODE FOR PERFORMING TWO-STAGE INDIVIDUAL PARTICIPANT DATA META-ANALYSIS 
Description The Stata package "ipdmetan" comprises a set of routines for conducting two-stage individual participant data (IPD) meta-analysis, and associated functionality. The main routine "ipdmetan" fits a specified regression model to the data from each study in turn, extracts the specified effect size and standard error, and generates pooled effects, heterogeneity statistics etc. as appropriate. Various random-effects models are available. The routine also provides the novel facility of including aggregate data from an external dataset; for instance if IPD were not available for some studies. The routine "forestplot" is a re-written and extended version of the graphics routine within the existing Stata command "metan". As well as being called by "ipdmetan", it is also designed to be run independently on saved datasets, allowing more complex forestplots to be created. The package also includes the routines "admetan", which performs inverse-variance aggregate-data meta-analysis as a direct alternative to the existing Stata command "metan"; and "petometan", which performs meta-analysis on binary or time-to-event data using the Peto (log-rank) method. Finally, the routine "ipdover" extracts effect sizes and standard errors within each level of each member of a list of categorical variables, to create a forestplot summarising subgroup results for a single randomised trial. 
Type Of Material Improvements to research infrastructure 
Year Produced 2014 
Provided To Others? Yes  
Impact The package is available from the SSC archive and can be found and installed from within Stata by typing "ssc describe ipdmetan" and "ssc install ipdmetan" respectively. Since it's release within the archive, the software has been downloaded 70 times per month on average. A Stata Journal article describing the functionality of the package is in press 
URL http://econpapers.repec.org/software/bocbocode/s457785.htm
 
Title Stata multiple imputation updates 
Description Updates to software in Stata to perform multiple imputation, a technique for dealing with missing data. Developed in collaboration with others. 
Type Of Material Improvements to research infrastructure 
Year Produced 2007 
Provided To Others? Yes  
Impact Used internationally by stata users when analysing medical research data. In 2011 became standard Stata command. ICE and MIM programs are available through the publicly accessible Statistical Software Components (SSC) archive from where the software has been downloaded in the region of 200 times per month since September 2012 
 
Description Adaptive Designs Working Group 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The HTMR Network supported the Adaptive Designs Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members.
Collaborator Contribution Scope: The Adaptive Designs Working Group collaborates to increase uptake of methods, to improve knowledge and to link with key stakeholders such as regulators and industry in this important area for improving the speed and efficiency of trials. Future objectives: The Network plays a vital role in increasing the implementation of adaptive design methodology, with the main barriers to implementation already identified as a lack of software and a lack of expertise. The future plans for this group include continued annual meetings, strengthening the engagement with industry and the development of collaborative inter-Hub visits to develop novel adaptive designs. The group is focusing its efforts on preparing tutorial papers for applied journals and mainstream medical journals; presentations and lectures to increase uptake of methods among stakeholders; and the development of computer software to help researchers to undertake trials with adaptive designs.
Impact Adaptive designs meet regularly and host an annual meeting on their research. There is an adaptive design outreach officer - paid for by the Network- who is undertaking regular visits to CTUs and is working on new research methodologies. To date (2016 Feb) 7 CTUs have been visited, and they have collaborated with one group on developing a trial application
Start Year 2010
 
Description Analysis of time to event IPD 
Organisation Medical Research Council (MRC)
Department MRC Biostatistics Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Responsible for develping and running simulations, analysing IPD and drafting a paper. Contributed to a related paper on methods of analyis of time to event IPD.
Collaborator Contribution Developed and ran simulations, analysed IPD, drafted one manucsript and contributed to another.Developed and ran simulations, analysed IPD, drafted one manuscript and contributed to another.
Impact 2 papers published
Start Year 2008
 
Description Analysis of time to event IPD 
Organisation Queen Mary University of London (QMUL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Responsible for develping and running simulations, analysing IPD and drafting a paper. Contributed to a related paper on methods of analyis of time to event IPD.
Collaborator Contribution Developed and ran simulations, analysed IPD, drafted one manucsript and contributed to another.Developed and ran simulations, analysed IPD, drafted one manuscript and contributed to another.
Impact 2 papers published
Start Year 2008
 
Description B1- Big Idea- Adaptive Design Outreach officer 
Organisation Lancaster University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network funding provided for this post
Collaborator Contribution This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs
Impact ongoing
Start Year 2014
 
Description B1- Big Idea- Adaptive Design Outreach officer 
Organisation Medical Research Council (MRC)
Department MRC Biostatistics Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Network funding provided for this post
Collaborator Contribution This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs
Impact ongoing
Start Year 2014
 
Description B1- Big Idea- Adaptive Design Outreach officer 
Organisation Medical Research Council (MRC)
Department MRC Clinical Trials Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Network funding provided for this post
Collaborator Contribution This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs
Impact ongoing
Start Year 2014
 
Description Clustering and covariates in the design and analysis of RCTs 
Organisation Queen Mary University of London (QMUL)
Department Queen Mary College
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual input
Collaborator Contribution Expertise and intellectual input
Impact A number of publications have resulted from this collaboration: PMID: 23825027, 24749914, 24755011, 24456267
Start Year 2014
 
Description Collaboration with AstraZeneca on cedaranib following ICON6 trial outcome 
Organisation AstraZeneca
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution Sponsored and ran the ICON6 trial after AZ abandoned development of this compound. Now working with them to produce licensing application. Anticipate considerable research support plus drug supply for trials to follow.
Collaborator Contribution Drug supply only until positive outcome of the study was reported. Subsequently, close colloaboration on preparation of regulatory package.
Impact Full study report in development
Start Year 2007
 
Description Evidence Synthesis Working Group 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The HTMR Network supports the Evidence Synthesis Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members.
Collaborator Contribution Scope- The Evidence Synthesis Working Group focuses on the use of evidence synthesis, or systematic reviews, in the design, monitoring and interpretation of trials. Future Objectives- The Working Group is preparing a series of papers to help trialists and others to make best use of evidence synthesis, including those based on the central collection and re-analysis of participant level data. It will develop clear recommendations for how evidence synthesis can be used in the design, conduct, and analysis of trials with a view to increasing the use of these methods in practice and reducing the waste in research that can arise when proper notice is not paid to existing evidence. "Position papers" will bring together work on the use of evidence synthesis in trial design, conduct and analysis in general, and compare methods for using evidence synthesis when estimating sample size requirements for new trials, using the Corticosteroid Randomisation After Significant Head injury (CRASH) trial as a worked example. Members of the Working Group are also collaborating to adapt the established principles for systematic reviews of trials to apply them elsewhere in the process of translational research, including within animal studies, evaluations of diagnostic tests and of prognostic models, and research to identify biomarkers and surrogate endpoints that might be used in trials.
Impact Ongoing activities. Hosting a session as part of the HTMR annual meeting
Start Year 2010
 
Description Freiburg 
Organisation University of Freiburg
Department Medical Biometry and Statistics Freiburg
Country Germany, Federal Republic of 
Sector Academic/University 
PI Contribution Joint collaborative research
Collaborator Contribution Joint collaborative research
Impact Several papers, including recently PUBMED 20191601
 
Description INVOLVE guidance for researchers on patient and public involvement in clinical trials 
Organisation Cancer Research UK (CRUK)
Department Wales Cancer Trials Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Impact Guidance published on submited INVOLVE website..
Start Year 2010
 
Description INVOLVE guidance for researchers on patient and public involvement in clinical trials 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Impact Guidance published on submited INVOLVE website..
Start Year 2010
 
Description INVOLVE guidance for researchers on patient and public involvement in clinical trials 
Organisation National Institute for Health Research (NIHR)
Department INVOLVE
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Impact Guidance published on submited INVOLVE website..
Start Year 2010
 
Description INVOLVE guidance for researchers on patient and public involvement in clinical trials 
Organisation University of Leeds
Department Leeds Clinical Trials Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website.Helped draft guidance on patient and public involvement in trials for the INVOLVE website Helped draft guidance on patient and public involvement in trials for the INVOLVE website
Impact Guidance published on submited INVOLVE website..
Start Year 2010
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews 
Organisation Lancaster University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Impact Guidance published on INVOLVE website.
Start Year 2009
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews 
Organisation National Institute for Health Research (NIHR)
Department INVOLVE
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Impact Guidance published on INVOLVE website.
Start Year 2009
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews 
Organisation National Institute for Health and Care Excellence (NICE)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Impact Guidance published on INVOLVE website.
Start Year 2009
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews 
Organisation The Cochrane Collaboration
Country Global 
Sector Charity/Non Profit 
PI Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Impact Guidance published on INVOLVE website.
Start Year 2009
 
Description INVOLVE guidance for researchers on patient and public involvement in systematic reviews 
Organisation University of York
Department Centre for Reviews and Dissemination (CRD)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Collaborator Contribution Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website Helped draft guidance on patient and public involvement in systematic reviews for the INVOLVE website
Impact Guidance published on INVOLVE website.
Start Year 2009
 
Description Leicester 
Organisation School of Medicine Leicester
Department Department of Health Sciences
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Joint collaborative research
Collaborator Contribution Joint collaborative research
Impact Several papers, including those in Stata Journal, and recently PUBMED 20213719
 
Description MAMS design for erosive lichen planus 
Organisation University of Nottingham
Department Centre of Evidence Based Dermatology
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Group keen to develop a methodologically efficient design to assess new treatments for women with vulval erosive lichen planus, a rare but debilitating condition. We have worked to help develop study designs, including updates to the multi-arm multi-stage approach, which will be covered in a PhD (Dan B). Eventually calculated that a multi-stage approach could not be used with the particular outcome measures required for the condition. Funding was successfully obtained for the trial which will be run from Nottingham CTU. MRC CTU's Scientific Strategy Group chose not to proceed with this. The unit has developed the first draft of the Statistical Analysis Plan and will engage in an advisory capacity. One member of the unit will serve on the IDMC.
Collaborator Contribution Treatment of patients, design and discussion and leadership of research.
Impact Grant applications submitted to NIHR and RfPB. Lead researcher has successfully won an NIHR fellowship during this time to contribute further to the research.
Start Year 2012
 
Description MAMS design for ocular melanoma 
Organisation Memorial Sloan Kettering Cancer Center
Country United States of America 
Sector Academic/University 
PI Contribution Development of potential designs to assess a number of agents simultaneously in clinical trial of treatment for relapsed ocular melanoma, a rare but rapidly fatal condition. Multi-arm multi-stage trials were dicussed and chosen as the design.
Collaborator Contribution Leadership of research, discussion with CTEP and other organisations.
Impact Two grant applications have been submitted. The first, to NCI CTEP, was not successful. A small trial will be undertaken which will be led from the US. MRC CTU did not wish to be involved with the specific design. Could return to the table for future discussions. Convinced the group that a multi-arm trial was appropriate.
Start Year 2011
 
Description MAMS design for ocular melanoma 
Organisation The Clatterbridge Cancer Centre NHS Foundation Trust
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Development of potential designs to assess a number of agents simultaneously in clinical trial of treatment for relapsed ocular melanoma, a rare but rapidly fatal condition. Multi-arm multi-stage trials were dicussed and chosen as the design.
Collaborator Contribution Leadership of research, discussion with CTEP and other organisations.
Impact Two grant applications have been submitted. The first, to NCI CTEP, was not successful. A small trial will be undertaken which will be led from the US. MRC CTU did not wish to be involved with the specific design. Could return to the table for future discussions. Convinced the group that a multi-arm trial was appropriate.
Start Year 2011
 
Description MAMS design for ocular melanoma 
Organisation University of Nottingham
Department School of Molecular Medical Sciences Nottingham
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Development of potential designs to assess a number of agents simultaneously in clinical trial of treatment for relapsed ocular melanoma, a rare but rapidly fatal condition. Multi-arm multi-stage trials were dicussed and chosen as the design.
Collaborator Contribution Leadership of research, discussion with CTEP and other organisations.
Impact Two grant applications have been submitted. The first, to NCI CTEP, was not successful. A small trial will be undertaken which will be led from the US. MRC CTU did not wish to be involved with the specific design. Could return to the table for future discussions. Convinced the group that a multi-arm trial was appropriate.
Start Year 2011
 
Description MRC BSU 
Organisation Medical Research Council (MRC)
Department MRC Biostatistics Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Joint collaborative research
Collaborator Contribution Joint collaborative research
Impact Several papers including recently PUBMED 19153970, 19452569, 21225900
 
Description MRC/DH/MHRA Joint Project 
Organisation Government of the UK
Department Department of Health (DH)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Input to the development of a risk stratification project as member of an ad hoc working group and co-chair of risk-stratification sub-group
Collaborator Contribution Input to the development of a risk stratification project as member of an ad hoc working group
Impact Guidance document (on MHRA website Oct 2011) "Risk-adapted approaches to the management of clinical trials of investigational medicinal products" incorporating guidance on risk adapted approaches within the scope of the Clinical Trials Directive and Guidance on risk-proportionate approaches to the management and monitoring of clinical trials. The collaboration is multi-disciplinary developed with input from a wide range of stakeholders including academic researchers, clinical trial managers, research governance managers, MHRA assessors and Good Clinical Practice Inspectors
Start Year 2009
 
Description MRC/DH/MHRA Joint Project 
Organisation Medicines and Healthcare Regulatory Agency (MHRA)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Input to the development of a risk stratification project as member of an ad hoc working group and co-chair of risk-stratification sub-group
Collaborator Contribution Input to the development of a risk stratification project as member of an ad hoc working group
Impact Guidance document (on MHRA website Oct 2011) "Risk-adapted approaches to the management of clinical trials of investigational medicinal products" incorporating guidance on risk adapted approaches within the scope of the Clinical Trials Directive and Guidance on risk-proportionate approaches to the management and monitoring of clinical trials. The collaboration is multi-disciplinary developed with input from a wide range of stakeholders including academic researchers, clinical trial managers, research governance managers, MHRA assessors and Good Clinical Practice Inspectors
Start Year 2009
 
Description Making decisions at the end of a Phase 2 clinical trial 
Organisation Amgen Inc
Country United States of America 
Sector Private 
PI Contribution Methodological development of an approach to the decision as to whether to proceed to a phase three trial at the end of phase two that synthesizes the available data. An exploration as to how this can also be used to design trials at phase two and three.
Collaborator Contribution Methodological development and simulation work as part of a PhD research project
Impact 2 research papers published and a further paper has been submitted; has had implications for how trial design decisions are made within Amgen
Start Year 2012
 
Description Methodological Expectations of Cochrane Intervention Reviews: Searchng for Studies 
Organisation The Cochrane Collaboration
Country Global 
Sector Charity/Non Profit 
PI Contribution As a member ot the working group will help evaluate the recommendations outlined in the Cochrane Handbook and amend, adapt and build on these accordingly on (i) searching for studies for inclusion in systematic reviews and (ii) clear reporting of the search process and search strategies.
Collaborator Contribution They will also help evaluate the recommendations outlined in the Cochrane Handbook and amend, adapt and build on these accordingly on (i) searching for studies for inclusion in systematic reviews and (ii) clear reporting of the search process and search strategies.
Impact Completed Methodological Expectations of Cochrane Intervention Reviews (MECIR) for searching for Studies.
Start Year 2011
 
Description Methodology Research Collaboration with industry 
Organisation AstraZeneca
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Collaborator Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Impact None yet
Start Year 2014
 
Description Methods for multiple imputation with multiple rating scales 
Organisation Bangor University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual input
Collaborator Contribution Expertise and intellectual input
Impact No outputs yet to report as the collaboration is ongoing
Start Year 2014
 
Description Multiple imputation by predictive mean matching using multilevel models 
Organisation INSERM Institut national de la santé et de la recherche médicale
Country France, French Republic 
Sector Public 
PI Contribution Expertise and intellectual input
Collaborator Contribution Expertise and intellectual input
Impact No outputs yet to report, collaboration still active. Manuscript submitted for publication - currently under review (Nov 2014)
Start Year 2014
 
Description Novel clinical trial design in a surgical setting (ROSSINI II) 
Organisation Birmingham Women's NHS Foundation Trust
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Key role in the trial design and sample size calculation. Developed a proposal for the design of the trial, using novel multi-arm multi-stage design, with binary outcome (total: eight arms).
Collaborator Contribution Responsible for submitting the funding application and running the clinical trial
Impact None yet.
Start Year 2014
 
Description Oxford 
Organisation Mathematical, Physical & Life Sciences Division
Department Department of Statistics
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Joint collaborative research
Collaborator Contribution Joint collaborative research
Impact Several papers including recently PUBMED 19477892, 19336487, 20641144
 
Description PRISMA-IPD Steering Group 
Organisation Queen's University of Belfast
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution. Steering Group membership (Jayne Tierney)
Collaborator Contribution Expertise and intellectual contribution.
Impact Development of reporting guidelines and a checklist for the standardised reporting of systematic reviews and meta-anlayses of IPD
Start Year 2012
 
Description PRISMA-IPD Steering Group 
Organisation Radboud University Nijmegen
Country Netherlands, Kingdom of the 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution. Steering Group membership (Jayne Tierney)
Collaborator Contribution Expertise and intellectual contribution.
Impact Development of reporting guidelines and a checklist for the standardised reporting of systematic reviews and meta-anlayses of IPD
Start Year 2012
 
Description PRISMA-IPD Steering Group 
Organisation University of Birmingham
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution. Steering Group membership (Jayne Tierney)
Collaborator Contribution Expertise and intellectual contribution.
Impact Development of reporting guidelines and a checklist for the standardised reporting of systematic reviews and meta-anlayses of IPD
Start Year 2012
 
Description PRISMA-IPD Steering Group 
Organisation University of York
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution. Steering Group membership (Jayne Tierney)
Collaborator Contribution Expertise and intellectual contribution.
Impact Development of reporting guidelines and a checklist for the standardised reporting of systematic reviews and meta-anlayses of IPD
Start Year 2012
 
Description R20 Workshop and guidance on IPD meta-analysis 
Organisation Queen's University of Belfast
Department The All-Ireland Hub for Trials Methodology Research
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution HTMR Network funded the project. MRC CTU London Hub- Leading the development of the funding proposal, project planning and organising, developing and running the workshop. Drafting and reviewing subsequenIPD t guidance papers
Collaborator Contribution Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers.
Impact publications: 25747860; 26186982; 26196287
Start Year 2011
 
Description R20 Workshop and guidance on IPD meta-analysis 
Organisation Radboud University Nijmegen
Country Netherlands, Kingdom of the 
Sector Academic/University 
PI Contribution HTMR Network funded the project. MRC CTU London Hub- Leading the development of the funding proposal, project planning and organising, developing and running the workshop. Drafting and reviewing subsequenIPD t guidance papers
Collaborator Contribution Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers.
Impact publications: 25747860; 26186982; 26196287
Start Year 2011
 
Description R20 Workshop and guidance on IPD meta-analysis 
Organisation University of Birmingham
Department MRC Midland Hub for Trials Methodology Research (MHTMR)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution HTMR Network funded the project. MRC CTU London Hub- Leading the development of the funding proposal, project planning and organising, developing and running the workshop. Drafting and reviewing subsequenIPD t guidance papers
Collaborator Contribution Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers.
Impact publications: 25747860; 26186982; 26196287
Start Year 2011
 
Description R20 Workshop and guidance on IPD meta-analysis 
Organisation University of Liverpool
Department North West Hub for Trials Methodology Research
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution HTMR Network funded the project. MRC CTU London Hub- Leading the development of the funding proposal, project planning and organising, developing and running the workshop. Drafting and reviewing subsequenIPD t guidance papers
Collaborator Contribution Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers.
Impact publications: 25747860; 26186982; 26196287
Start Year 2011
 
Description R20 Workshop and guidance on IPD meta-analysis 
Organisation University of York
Department Centre for Reviews and Dissemination (CRD)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution HTMR Network funded the project. MRC CTU London Hub- Leading the development of the funding proposal, project planning and organising, developing and running the workshop. Drafting and reviewing subsequenIPD t guidance papers
Collaborator Contribution Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers.
Impact publications: 25747860; 26186982; 26196287
Start Year 2011
 
Description R25- Remits, roles and working models for Trial Steering Committees and Data Monitoring Committees in clinical trials evaluating diagnostic tests, most notably test accuracy studies. 
Organisation University of Southampton
Department NIHR Evaluation, Trials and Studies Coordinating Centre
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network support- funding provided for this project- links in with a suite of Network research
Collaborator Contribution Review, workshop and expert consensus expected in 2015
Impact Review, workshop and expert consensus expected. Collaborative work only just begun
Start Year 2012
 
Description R34 An ethnographic study of group decision making and member roles in TSC and TMG 
Organisation Medical Research Council (MRC)
Department MRC ConDuCT Trials Methodology Hub
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Network funded project to work on An ethnographic study of group decision-making and member roles to understand and improve how Trial Steering Committees and Trial Management Groups contribute to trial conduct"
Collaborator Contribution Funding from the Network given.
Impact Findings from the study have been successfully disseminated at a variety of conferences and workshops. These include: oral presentations at the MRC Trials Methodology Conference in Edinburgh (November 2013) and the South West Society for Academic Primary Care Conference in Bristol (March 2014). The study methods have been disseminated to the trials community through a Qualitative Research in Trials workshop at the University of Bristol (May 2013). A poster presentation was given at the Society for Clinical Trials in Philadelphia, USA (May 2014). Publications have been submitted to Trials and await decision ( as Jan 2016)
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation European Organisation for Research and Treatment of Cancer (EORTC)
Country European Union (EU) 
Sector Charity/Non Profit 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation Hub at the MRC/CRUK/BHF Clinical Trial Service Unit
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation Medical Research Council (MRC)
Department MRC Hubs for Trial Methodology Research
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation University of Birmingham
Department Midland Hub for Trials Methodology Research
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation University of Edinburgh
Department Edinburgh Hub for Trials Methodology Research
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description R39 Agreeing current good practice for clinical trial data access and sharing 
Organisation University of Liverpool
Department North West Hub
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Network funded proposal- This proposal addresses a main priority area for the HTMR Network, that of using existing evidence in the prioritisation, design and planning, conduct, and interpretation of trials, all of which can be helped by improving access to clinical trial data.
Collaborator Contribution Network funding provided for project commencement
Impact Outputs include publication:DOI 10.1186/s12916-015-0532-z http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z Also this has been highlighted in the Network Guidance pack. http://methodologyhubs.mrc.ac.uk/advice/network-guidance/ The guidance has been cited by various parties as of value including "This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance." Finally, the PI, together with colleagues within the Network have contributed to a publications from Springer Nature entitled " Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organizations" Following a consultation, their comments have been used to revise these guidelines.
Start Year 2013
 
Description Re-randomisation of patients to a clinical trial 
Organisation Monash University
Country Australia, Commonwealth of 
Sector Academic/University 
PI Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design
Collaborator Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Impact Several invited seminars (Leeds, Leicester, LSHTM), conference papers, one published paper.
Start Year 2014
 
Description Re-randomisation of patients to a clinical trial 
Organisation Queen Mary University of London (QMUL)
Department Queen Mary College
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design
Collaborator Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Impact Several invited seminars (Leeds, Leicester, LSHTM), conference papers, one published paper.
Start Year 2014
 
Description Sample size calculations for cluster randomised trials 
Organisation Queen Mary University of London (QMUL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Review of how sample size calculations are made and reported in cluster randomised trials, critical review of the published sample formulae with practical guidance. Further work will include development of guidance for calculating sample size for trials with an ordinal outcome
Collaborator Contribution Joint supervision of PhD student
Impact Two research papers have been published and a presentation has been made at a conference. One further article is in development
Start Year 2011
 
Description Stepped wedge trial design 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Intellectual contribution to all activities, lead authorship on one of 6 publications
Collaborator Contribution Intellectual contributions
Impact Special issue of Trials (6 articles), workshop to present the findings. Further collaboration with other parts of UCL as well as with LSHTM. Work is already being cited.
Start Year 2014
 
Description Strategies to reduce attrition 
Organisation Medical Research Council (MRC)
Department MRC General Practice Research Framework
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Key role in protocol development, searching for trials, data extraction, analysis and interpretation for a systematic review of strategies to reduce attrition from trials. Involved in the development of the protocol and structured interviews and the thematic anaylsis of interview transcripts for a qualitative review of trial investigators, trial mangers and research nurses views on strategies to reduce attrition from trials.
Collaborator Contribution Involved in all aspects of the design and conduct of both a systematic review and qualitative review of strategies to reduce attrition from randomised trials.
Impact For the systematic review, 1 published protocol and 2 presentations international and 2 presentations at national conferences. For the qualitative review 3 presentations at national conferences. This is a multidisciplinary collaboration including clinicians, IPD meta analysis experts, statisticians and qualitative researchers.
Start Year 2008
 
Description Stratified Medicine WG 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution The HTMR Network supports the Stratified Medicine Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members.
Collaborator Contribution Scope- Stratified Medicine is about tailoring treatments to specific patients, helping to ensure the highest chance of benefit and minimising the potential for harm or unnecessary treatment The Stratified Medicine Working Group collaborates to look at novel designs for biomarker-stratified trials, and to bring the stratified medicine approach into a wider range of disease areas, complementing work already done in the widely studied examples of cancer and heart disease. Future Objectives- The Working Group is preparing a guidance paper to help people reading a stratified medicine research paper, and has started to explore means for delivering advice to applicants to the MRC Research Panel on Stratified Medicine. Members of the Working Group are also planning to develop prognostic models that help in the prediction of harms and benefits following the use of thrombolysis to treat stroke, drawing on individual participant data meta-analysis of clinical trials.
Impact ongoing collaborations.
Start Year 2012
 
Description Stregthening the Analytical Thinking for Observational Studies: STRATOS initiatve 
Organisation University of Freiburg
Country Germany, Federal Republic of 
Sector Academic/University 
PI Contribution Member of the steering committee (James Carpenter) and co-author of the paper in Statistics in Medicine which introduced this initiative
Collaborator Contribution Besides steering group membership, chair of the Topic Group on missing data, responsible for leading the activities of this group
Impact One paper has been published
Start Year 2014
 
Description Trials conduct methodology collaboration 
Organisation University College London (UCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Collaborator Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Impact No outcomes to report as yet - collaboration still active
Start Year 2014
 
Description Trials conduct methodology collaboration 
Organisation University College London (UCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Collaborator Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Impact No outcomes to report as yet - collaboration still active
Start Year 2014
 
Description Trials conduct methodology collaboration 
Organisation University College London (UCL)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Collaborator Contribution Expertise and intellectual contribution to push forward some specific areas of trial conduct methodoological research
Impact No outcomes to report as yet - collaboration still active
Start Year 2014
 
Description Using causal analyses to add value to large RCTs 
Organisation University of Bristol
Department MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Multiple 
PI Contribution To help develop "best practice" examples to guide statisticians working in clinical academia in the use of causal methods To help systematically survey the clinical literature, and to conduct a scoping exercise to identify types of questions which causal models have most potential to answer in RCTs To help apply causal inference methods to use RCT data to answer two new clinical questions of different types To help disseminate best practice through workshops,
Collaborator Contribution To help develop "best practice" examples to guide statisticians working in clinical academia in the use of causal methods To help systematically survey the clinical literature, and ro conduct a scoping exercise to identify types of questions which causal models have most potential to answer in RCTs To help apply causal inference methods to use RCT data to answer two new clinical questions of different types To help disseminate best practice through workshops,
Impact Funding from the MRC Population and Health Sciences Network (to fund a cross-unit appointment for a joint appointment between CTU and CaiTE) commenced in April 2014 (until 2017)
Start Year 2012
 
Description 2014 4th student symposia HTMR 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Student meeting- organised by London Hub to encourage engagement within the student cohort

Feedback from the workshop was positive, with many students highlighting this was a perfect eent to engage with their methodology peers
Year(s) Of Engagement Activity 2014
 
Description ICTMC2015 - Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The HTMR Network organised the 3rd International Clinical Trials Methodology Conference (ICTMC2015) at Glasgow in November 2015.
Over 600 delegates attended. The conference included parallel presentations of new methods, plenary talks and keynote discussions.
Year(s) Of Engagement Activity 2015
URL http://ictmc.uk/
 
Description Trial Conduct Working Group- webinar on-site monitoring 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Trial Conduct WG organised a webinar on Developing evidence-based approaches to use of on-site monitoring in October 2014. This stimulated discussion and consideration of a specific methodology research topic

discussion and slides available following meeting
Year(s) Of Engagement Activity 2014
URL http://www.methodologyhubs.mrc.ac.uk/pdf/evidence-based%20approaches.pdf