MRC Clinical Trials Unit as the London Hub for Trials Methodology Research
Lead Research Organisation:
MRC Clinical Trials Unit
Department Name: UNLISTED
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
- MRC Clinical Trials Unit (Lead Research Organisation)
- The Clatterbridge Cancer Centre NHS Foundation Trust (Collaboration)
- European Medicines Agency (Collaboration)
- European Organisation for Research and Treatment of Cancer (EORTC) (Collaboration)
- Medicines and Healthcare Regulatory Agency (Collaboration)
- Memorial Sloan Kettering Cancer Center (Collaboration)
- University of Warwick (Collaboration)
- Health Data Research UK (Collaboration)
- QUEEN MARY UNIVERSITY OF LONDON (Collaboration)
- The Cochrane Collaboration (Collaboration)
- Birmingham Women's and Children's NHS Foundation Trust (Collaboration)
- Amgen Inc (Collaboration)
- The Global Health Network (Collaboration)
- UNIVERSITY OF BIRMINGHAM (Collaboration)
- Albert Ludwig University of Freiburg (Collaboration)
- UNIVERSITY OF LEEDS (Collaboration)
- Radboud University Nijmegen (Collaboration)
- UNIVERSITY OF LIVERPOOL (Collaboration)
- Medical Research Council (MRC) (Collaboration)
- University of Bristol (Collaboration)
- UNIVERSITY OF SOUTHAMPTON (Collaboration)
- University College London (Collaboration)
- UNIVERSITY OF LEICESTER (Collaboration)
- UNIVERSITY OF NOTTINGHAM (Collaboration)
- Trials Methodology Research Network (Collaboration)
- Lancaster University (Collaboration)
- PUBLIC HEALTH ENGLAND (Collaboration)
- National Institute of Health and Medical Research (INSERM) (Collaboration)
- Department of Health (DH) (Collaboration)
- UKCRC Registered trials CTU network (Collaboration)
- National Institute for Health Research (Collaboration)
- QUEEN'S UNIVERSITY BELFAST (Collaboration)
- IMPERIAL COLLEGE LONDON (Collaboration)
- UNIVERSITY OF CAMBRIDGE (Collaboration)
- National Institute for Health and Care Excellence (NICE) (Collaboration)
- AstraZeneca (United Kingdom) (Collaboration)
- Cancer Research UK (Collaboration)
- UNIVERSITY OF OXFORD (Collaboration)
- UK Trial Managers Network (Collaboration)
- BANGOR UNIVERSITY (Collaboration)
- London School of Hygiene and Tropical Medicine (LSHTM) (Collaboration)
- Hub at the MRC/CRUK/BHF Clinical Trial Service Unit (Collaboration)
- UNIVERSITY OF YORK (Collaboration)
- UNIVERSITY OF EDINBURGH (Collaboration)
- Monash University (Collaboration)
- KING'S COLLEGE LONDON (Collaboration)
People |
ORCID iD |
Publications
Bartlett JW
(2014)
Improving upon the efficiency of complete case analysis when covariates are MNAR.
in Biostatistics (Oxford, England)
Bartlett JW
(2015)
Multiple imputation of covariates by fully conditional specification: Accommodating the substantive model.
in Statistical methods in medical research
Binder H
(2013)
Comparison between splines and fractional polynomials for multivariable model building with continuous covariates: a simulation study with continuous response.
in Statistics in medicine
Bowden J
(2011)
Individual patient data meta-analysis of time-to-event outcomes: one-stage versus two-stage approaches for estimating the hazard ratio under a random effects model.
in Research synthesis methods
Bowden J
(2011)
Quantifying, displaying and accounting for heterogeneity in the meta-analysis of RCTs using standard and generalised Q statistics.
in BMC medical research methodology
Bratton D
(2015)
Comments on 'A modest proposal for dropping poor arms in clinical trials' by Proschan and Dodd LETTER TO THE EDITOR
in Statistics in Medicine
Bratton Daniel J.
(2015)
A menu-driven facility for sample-size calculation in multiarm, multistage randomized controlled trials with time-to-event outcomes: Update
in STATA JOURNAL
Bratton DJ
(2013)
A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis.
in BMC medical research methodology
| 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 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 |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| 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 | MRC Population Health Sciences Research Network (PHSRN) |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | |
| Description | Cross-Unit Appointment: Using causal analyses to add value to large RCTs |
| Amount | £185,000 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Population Health Sciences Research Network (PHSRN) |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | 04/2014 |
| Description | Health Data Research (UK) funding |
| Amount | £202,717 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 10/2018 |
| End | 10/2021 |
| 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 |
| 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 | Public |
| Country | United Kingdom |
| 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 | Public |
| Country | United Kingdom |
| Start | 04/2014 |
| End | 03/2014 |
| Description | MRC research grant - the Re-IMAGINE consortium |
| Amount | £6,347,795 (GBP) |
| Funding ID | MR/R014043/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 06/2018 |
| End | 05/2022 |
| Description | NIHR Fellowship: Analysis of recurrent events in clinical trials |
| Amount | £100,000 (GBP) |
| Funding ID | PDF-2013-06-024 |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| 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 |
| 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 | 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... |
| 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 |
| 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 | Queen Mary University of London |
| Country | United Kingdom |
| 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 | Analysis of time to event IPD |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| 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 |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this post |
| Collaborator Contribution | This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs |
| Impact | ongoing |
| Start Year | 2014 |
| Description | B1- Big Idea- Adaptive Design Outreach officer |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | 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 | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Network funding provided for this post |
| Collaborator Contribution | This proposal is for an "Adaptive Design Outreach Officer" who would be associated with the Adaptive Designs Working Group (ADWG). The key aim would be to raise awareness and use of adaptive designs across a broad range of diseases and across the development and assessment spectrum. Adaptive methods in this context are defined in its broadest sense end will include Bayesian adaptive dose-finding and group-sequential methods, multi-arm trials, lack-of-benefit stopping rules and sample size reassessment methods. The main activity of the outreach officer would be to proactively engage with applied health researchers to discuss the merits and relative drawbacks of the currently available adaptive designs. In particular, the outreach officer would: 1. Develop training material on current adaptive designs 2. Visit each of the UKCRC registered Clinical Trials Units1 to present about the potential of adaptive designs 3. Facilitate the uptake and implementation of adaptive designs 4. Support the writing of tutorial papers on adaptive designs |
| Impact | ongoing |
| Start Year | 2014 |
| Description | Clustering and covariates in the design and analysis of RCTs |
| Organisation | Queen Mary University of London |
| Country | United Kingdom |
| 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 | Evidence Synthesis Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The HTMR Network supports the Evidence Synthesis Working Group (WG) to regularly meet and exchange ideas. This involves members of the methodology community and Hub members. |
| Collaborator Contribution | Scope- The Evidence Synthesis Working Group focuses on the use of evidence synthesis, or systematic reviews, in the design, monitoring and interpretation of trials. Future Objectives- The Working Group is preparing a series of papers to help trialists and others to make best use of evidence synthesis, including those based on the central collection and re-analysis of participant level data. It will develop clear recommendations for how evidence synthesis can be used in the design, conduct, and analysis of trials with a view to increasing the use of these methods in practice and reducing the waste in research that can arise when proper notice is not paid to existing evidence. "Position papers" will bring together work on the use of evidence synthesis in trial design, conduct and analysis in general, and compare methods for using evidence synthesis when estimating sample size requirements for new trials, using the Corticosteroid Randomisation After Significant Head injury (CRASH) trial as a worked example. Members of the Working Group are also collaborating to adapt the established principles for systematic reviews of trials to apply them elsewhere in the process of translational research, including within animal studies, evaluations of diagnostic tests and of prognostic models, and research to identify biomarkers and surrogate endpoints that might be used in trials. |
| Impact | Ongoing activities. Hosting a session as part of the HTMR annual meeting |
| Start Year | 2010 |
| Description | Freiburg |
| Organisation | Albert Ludwig University of Freiburg |
| Department | Institute for Medical Biometry and Statistics |
| Country | Germany |
| Sector | Academic/University |
| PI Contribution | Joint collaborative research |
| Collaborator Contribution | Joint collaborative research |
| Impact | Several papers, including recently PUBMED 20191601 |
| 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 | INVOLVE guidance for researchers on patient and public involvement in clinical trials |
| Organisation | Cancer Research UK |
| Department | Wales Cancer Trials Unit |
| Country | United Kingdom |
| 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 |
| 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 |
| Department | INVOLVE |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| Department | INVOLVE |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 | University of Leicester |
| Department | Department of Health Sciences |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| 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 | Department of Health (DH) |
| Country | United Kingdom |
| 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 |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| 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 | National Institute of Health and Medical Research (INSERM) |
| Country | France |
| Sector | Academic/University |
| 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 and Children's NHS Foundation Trust |
| Country | United Kingdom |
| 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 | 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 | Oxford |
| Organisation | University of Oxford |
| Department | Department of Statistics |
| Country | United Kingdom |
| 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 Belfast |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| 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 | Medical Research Council (MRC) |
| Department | MRC Midland Hub for Trials Methodology Research (MHTMR) |
| Country | United Kingdom |
| 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 | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| 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 | Queen's University Belfast |
| Department | The All-Ireland Hub for Trials Methodology Research |
| Country | United Kingdom |
| 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 |
| 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 York |
| Department | Centre for Reviews and Dissemination (CRD) |
| Country | United Kingdom |
| 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 |
| 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 |
| Sector | Academic/University |
| 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 | Belgium |
| 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 |
| 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 |
| 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 | Medical Research Council (MRC) |
| Department | MRC Midland Hub for Trials Methodology Research (MHTMR) |
| Country | United Kingdom |
| 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 North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| Country | United Kingdom |
| 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 | 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 | Sample size calculations for cluster randomised trials |
| Organisation | Queen Mary University of London |
| Country | United Kingdom |
| 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 |
| 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 |
| 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 |
| 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 | Albert Ludwig University of Freiburg |
| Country | Germany |
| 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 |
| Country | United Kingdom |
| 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 |
| Country | United Kingdom |
| 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 |
| Country | United Kingdom |
| 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 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 | Trials Methodology Research Network |
| Country | Ireland |
| 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 | 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 |
| Description | Using causal analyses to add value to large RCTs |
| Organisation | University of Bristol |
| Department | MRC Centre for Causal Analyses in Translational Epidemiology |
| Country | United Kingdom |
| Sector | Academic/University |
| 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 |
| 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 | 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 | 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 |
| 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 |