Effective and efficient conduct of trials and meta-analyses
Lead Research Organisation:
University College London
Abstract
Our work in this area involves investigating and improving trial data checking and monitoring, as well as reducing bias and improving the validity of our systematic reviews. Some of the important outcomes are:
Evidence-based trial monitoring
• Many trials organisations have implemented trial management and monitoring procedures out of proportion to the risks to trial participants or the public, thereby increasing the workload, complexity and cost of lower-risk trials. We initiated the TEMPER study to evaluate prospectively whether triggered monitoring is effective at distinguishing problem sites in ongoing CTU multicentre cancer trials.
Increasing participant retention in trials
• Our systematic review of strategies to increase participant retention specifically in RCTs has shown that monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Non-monetary incentives, additional communication and reminder strategies and most modified questionnaires have little impact.
Informing systematic review conduct
• CTU is leading a Network-funded project to develop a ‘state of the art’ series of papers on Individual participant data (IPD) meta-analyses and recently hosted a workshop of international experts to discuss topics. Most systematic reviews now assess risk of bias of eligible trials based on their publications (often using the Cochrane Collaboration tool), and it has been proposed that these are used as a basis for including or weighting trials in a meta-analysis. An evaluation of publication-based assessments showed that they can be unreliable, compared to those based on information obtained from investigators or protocols (as part of our IPD meta-analyses). In particular, reviewers should be cautious about using these as a basis for trial inclusion, and instead seek additional information from trialists, where possible.
Evidence-based trial monitoring
• Many trials organisations have implemented trial management and monitoring procedures out of proportion to the risks to trial participants or the public, thereby increasing the workload, complexity and cost of lower-risk trials. We initiated the TEMPER study to evaluate prospectively whether triggered monitoring is effective at distinguishing problem sites in ongoing CTU multicentre cancer trials.
Increasing participant retention in trials
• Our systematic review of strategies to increase participant retention specifically in RCTs has shown that monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Non-monetary incentives, additional communication and reminder strategies and most modified questionnaires have little impact.
Informing systematic review conduct
• CTU is leading a Network-funded project to develop a ‘state of the art’ series of papers on Individual participant data (IPD) meta-analyses and recently hosted a workshop of international experts to discuss topics. Most systematic reviews now assess risk of bias of eligible trials based on their publications (often using the Cochrane Collaboration tool), and it has been proposed that these are used as a basis for including or weighting trials in a meta-analysis. An evaluation of publication-based assessments showed that they can be unreliable, compared to those based on information obtained from investigators or protocols (as part of our IPD meta-analyses). In particular, reviewers should be cautious about using these as a basis for trial inclusion, and instead seek additional information from trialists, where possible.
Technical Summary
There is an urgent need for new methods for many clinical studies. One challenge is finding cost-effective, evidence-based methods for running trials. This increases the likelihood of producing reliable results in a timely manner, which in turn frees resources to allow more trials to take place. We will do this by developing and evaluating methods for ensuring that trials are run effectively and efficiently. We are providing practical examples of how novel designs can be implemented; evaluating and implementing strategies to ensure that data quantity and quality are maximised and that staff time locally and at sites is best used. We are also investigating how to get trials started and reported more quickly, and to make appropriate use of e-health resources.
Gains from efficient conduct may be dissipated or lost completely if evidence synthesis of trials is protracted, inefficient or poorly conducted. Furthermore, if understanding or use of systematic reviews is limited, then clinical practice and research may not be informed by the best evidence. We will address these issues by developing a new framework for meta-analysis to speed up the evaluation of individual therapies; providing tools and guidance to promote greater awareness, understanding and use of IPD meta-analysis across a variety of stakeholders and resolving outstanding issues in systematic review conduct.
Gains from efficient conduct may be dissipated or lost completely if evidence synthesis of trials is protracted, inefficient or poorly conducted. Furthermore, if understanding or use of systematic reviews is limited, then clinical practice and research may not be informed by the best evidence. We will address these issues by developing a new framework for meta-analysis to speed up the evaluation of individual therapies; providing tools and guidance to promote greater awareness, understanding and use of IPD meta-analysis across a variety of stakeholders and resolving outstanding issues in systematic review conduct.
Organisations
- University College London, United Kingdom (Collaboration, Lead Research Organisation)
- University of Hasselt, Belgium (Collaboration)
- European Organisation for Research and Treatment of Cancer (EORTC) (Collaboration)
- University of Edinburgh, United Kingdom (Collaboration)
- Public Health England, United Kingdom (Collaboration)
- Amgen Inc (Collaboration)
- University of Sydney, Australia (Collaboration)
- Newcastle University, United Kingdom (Collaboration)
- Keele University, United Kingdom (Collaboration)
- National Cancer Registration and Analysis Service (Collaboration)
- Harvard University (Collaboration)
- University of Liverpool, United Kingdom (Collaboration)
- AstraZeneca plc (Collaboration)
- University of Nottingham (Collaboration)
- Saarland University, Germany (Collaboration)
- University of Oxford, United Kingdom (Collaboration)
- Hub at the MRC/CRUK/BHF Clinical Trial Service Unit (Collaboration)
- University of Bristol, United Kingdom (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- London Sch of Hygiene and Trop Medicine, United Kingdom (Collaboration)
- University Medical Centre Utrecht, Netherlands (Collaboration)
- University of Birmingham, United Kingdom (Collaboration)
- Medicines and Healthcare Regulatory Agency (Collaboration)
- University of Aberdeen, United Kingdom (Collaboration)
- European Medicines Agency (Collaboration)
- NHS Health Research Authority (Collaboration)
- The Global Health Network (Collaboration)
- King's College London, United Kingdom (Collaboration)
- University of Southampton, United Kingdom (Collaboration)
- BioMarin Pharmaceutical (Collaboration)
- Imperial Cancer Research Fund (Collaboration)
- Queen Mary, University of London, United Kingdom (Collaboration)
- Novartis (Collaboration)
- F. Hoffmann-La Roche AG (Collaboration)
- Brown University, United States (Collaboration)
- Vectura Ltd (Collaboration)
- Bayer (Collaboration)
- University of Basel, Switzerland (Collaboration)
- University of Warwick, United Kingdom (Collaboration)
- Zoology Ecology and Plant Science (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- Queen's University of Belfast, United Kingdom (Collaboration)
- University of York, United Kingdom (Collaboration)
- Medical Research Council (Collaboration)
- University of Leeds, United Kingdom (Collaboration)
- Radboud University Nijmegen, Netherlands (Collaboration)
- Health Data Research Uk, London (Collaboration)
- NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (Collaboration)
- University of Manchester, Manchester, United Kingdom (Collaboration)
Publications
Brueton V
(2017)
Best practice guidance for the use of strategies to improve retention in randomized trials developed from two consensus workshops.
in Journal of clinical epidemiology
Choodari-Oskooei Babak
(2016)
Quantifying the uptake of user-written commands over time
in STATA JOURNAL
Clayton GL
(2017)
The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.
in Trials
Conroy EJ
(2015)
Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences.
in Clinical trials (London, England)
| Description | Data sharing guidance cited in CRUK guidance |
| Geographic Reach | National |
| Policy Influence Type | Citation in other policy documents |
| URL | http://www.cancerresearchuk.org/sites/default/files/hands_on_data_sharing_advice_-_clinical.pdf |
| Description | Guidance on sharing of data from publicly funded trials |
| Geographic Reach | National |
| Policy Influence Type | Citation in other policy documents |
| URL | http://www.ct-toolkit.ac.uk/routemap/ |
| Description | Patient Information Sheet template and guidance referenced in HRA guidance |
| Geographic Reach | National |
| Policy Influence Type | Citation in other policy documents |
| URL | http://www.hra.nhs.uk/documents/2017/01/applying-proportionate-approach-process-seeking-consent.pdf |
| Description | Patient Information Sheet template referenced in HRA guidance |
| Geographic Reach | National |
| Policy Influence Type | Citation in other policy documents |
| URL | https://www.hra.nhs.uk/documents/283/applying-proportionate-approach-process-seeking-consent_R3gbJKn... |
| 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 | Health Data Research (UK) funding |
| Amount | £202,717 (GBP) |
| Organisation | Health Data Research UK |
| Start | 10/2018 |
| End | 10/2021 |
| Description | MRC Hub for Trials Methodology Research (HTMR) - extension |
| Amount | £500,000 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | 04/2014 |
| End | 04/2015 |
| Description | MRC Methodology Research Panel: Missing data in propensity score analyses of Electronic Health Records Data |
| Amount | £400,000 (GBP) |
| Funding ID | MR/M013278/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | 09/2016 |
| End | 08/2019 |
| 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 | PIS template |
| Description | New Patient Information Sheet template and associated guidance, developed for use at the CTU but shared externally with over 60 other researchers (so far). |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2015 |
| Provided To Others? | Yes |
| Impact | HRA is due to include a reference to this tool in their updated PIS guidance. |
| URL | http://www.ctu.mrc.ac.uk/resources/patient_involvement/ |
| Title | ORRCA - Online Resource for Recruitment research in Clinicals triAls |
| Description | Online database of recruitment research, with search functions |
| Type Of Material | Database/Collection of data |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | http://www.orrca.org.uk/ |
| Description | Children and Young People in trials - online learning resource |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Contributions made to planning of this project, coordinated by researchers at Queens University, Belfast. |
| Collaborator Contribution | Coordination and overall responsibility for the project. |
| Impact | None so far |
| Start Year | 2015 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | Brown University |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | Keele University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | Radboud University Nijmegen |
| Country | Netherlands |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University Medical Center Utrecht (UMC) |
| Country | Netherlands |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University of Hasselt |
| Department | International Drug Development Institute |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University of Sydney |
| Country | Australia |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | Cochrane IPD Synthesis Working Group |
| Organisation | University of York |
| Department | Centre for Reviews and Dissemination (CRD) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Participated in teleconference discussions and preparation of the final report |
| Collaborator Contribution | Participated in teleconference discussions and preparation of the final report |
| Impact | Cochrane IPD Synthesis Working Group Report |
| Start Year | 2017 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Amgen Inc |
| Country | United States |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Bayer |
| Country | Germany |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | BioMarin Pharmaceutical |
| Country | United States |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | F. Hoffmann-La Roche AG |
| Country | Global |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | MRC North West Hub for Trials Methodology Research |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Novartis |
| Country | Global |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Saarland University |
| Country | Germany |
| Sector | Academic/University |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | University of Manchester |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | EFSPI/PSI Data Sharing Working Group |
| Organisation | Vectura Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Input into an EFSPI / PSI working group and conrtibution to manuscript development |
| Collaborator Contribution | Aims of the working group are: •To identify and prospectively prioritize statistical issues in data transparency •To co-ordinate statistical contributions across Europe to the data transparency debate •To disseminate relevant information on the topic across the statistical community •To develop and share a vision of the potential longer term impact of data transparency. Members of the collaboration led the working group, all partners involved in planning and contributing to manuscripts |
| Impact | Series of manuscripts outlining best practice for preparation and analysis of shared clinical trial data is in preparation (two submitted) |
| Start Year | 2014 |
| Description | Evidence Synthesis Working Group |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Hubs for Trial Methodology Research |
| Country | United Kingdom |
| Sector | Public |
| 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 | The Evidence Synthesis Working Group focuses on the use of evidence synthesis, or systematic reviews, in the design, conduct and analysis of trials. The Working Group has prepared a series of papers to help trialists and others to make best use of evidence synthesis. |
| Impact | A number of papers are in draft form and a survey (INVEST) of use of evidence synthesis was conducted at the 3rd International Clinical Trials Methodology Conference |
| Start Year | 2010 |
| 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 | 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 | Methodology Research Collaboration with industry |
| Organisation | Amgen Inc |
| Country | United States |
| 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 | 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 | Methodology Research Collaboration with industry |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| 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 | 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 | ORRCA - Online Resource for Recruitment research in Clinical triAls |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Categorisation of research papers for the ORRCA recruitment database. |
| Collaborator Contribution | Development of, and overall responsibility for resource and related publications. |
| Impact | ORRCA database. |
| Start Year | 2016 |
| Description | PRISMA-IPD Steering Group |
| Organisation | Queen's University Belfast |
| Department | MRC All-Ireland Methodology Hub |
| Country | United Kingdom |
| Sector | Multiple |
| 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-analyses of IPD. This has been published |
| 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-analyses of IPD. This has been published |
| 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-analyses of IPD. This has been published |
| 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-analyses of IPD. This has been published |
| Start Year | 2012 |
| Description | Partnership with HRA, MHRA and NCRAS/PHE for source data verification project |
| Organisation | Medicines and Healthcare Regulatory Agency |
| Department | General Practice Research Database (GPRD) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data. |
| Collaborator Contribution | The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful. |
| Impact | None so far |
| Start Year | 2017 |
| Description | Partnership with HRA, MHRA and NCRAS/PHE for source data verification project |
| Organisation | NHS Health Research Authority |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data. |
| Collaborator Contribution | The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful. |
| Impact | None so far |
| Start Year | 2017 |
| Description | Partnership with HRA, MHRA and NCRAS/PHE for source data verification project |
| Organisation | National Cancer Registration and Analysis Service |
| PI Contribution | MRC CTU is leading some work on whether electronic health record data could be used to check the quality of clinical trial data. |
| Collaborator Contribution | The partner organisations are helping us set this up and discussing relevant issues; NCRAS/PHE will help by providing data if the project is successful. |
| Impact | None so far |
| Start Year | 2017 |
| Description | Protocol for systematic review of trial monitoring |
| Organisation | University of Basel |
| Country | Switzerland |
| Sector | Academic/University |
| PI Contribution | Assitance and input to plans to develop a Protocol |
| Collaborator Contribution | Assitance and input to plans to develop a Protocol |
| Impact | Not yet |
| Start Year | 2018 |
| Description | R20 Workshop and guidance on IPD meta-analysis |
| Organisation | Queen's University Belfast |
| Department | MRC All-Ireland Methodology Hub |
| Country | United Kingdom |
| Sector | Multiple |
| PI Contribution | Leading the development of the funding proposal, project planning and organising, developing and running a workshop. Drafting and reviewing subsequent IPD guidance papers |
| Collaborator Contribution | Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers. |
| Impact | We brought international experts to the Unit to discuss key IPD topics, develop guidance outlines and establish writing committees. We have published four papers. |
| Start Year | 2011 |
| Description | R20 Workshop and guidance on IPD meta-analysis |
| Organisation | Radboud University Nijmegen |
| Country | Netherlands |
| Sector | Academic/University |
| PI Contribution | Leading the development of the funding proposal, project planning and organising, developing and running a workshop. Drafting and reviewing subsequent IPD guidance papers |
| Collaborator Contribution | Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers. |
| Impact | We brought international experts to the Unit to discuss key IPD topics, develop guidance outlines and establish writing committees. We have published four papers. |
| Start Year | 2011 |
| Description | R20 Workshop and guidance on IPD meta-analysis |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leading the development of the funding proposal, project planning and organising, developing and running a workshop. Drafting and reviewing subsequent IPD guidance papers |
| Collaborator Contribution | Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers. |
| Impact | We brought international experts to the Unit to discuss key IPD topics, develop guidance outlines and establish writing committees. We have published four papers. |
| Start Year | 2011 |
| Description | R20 Workshop and guidance on IPD meta-analysis |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leading the development of the funding proposal, project planning and organising, developing and running a workshop. Drafting and reviewing subsequent IPD guidance papers |
| Collaborator Contribution | Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers. |
| Impact | We brought international experts to the Unit to discuss key IPD topics, develop guidance outlines and establish writing committees. We have published four papers. |
| Start Year | 2011 |
| Description | R20 Workshop and guidance on IPD meta-analysis |
| Organisation | University of York |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leading the development of the funding proposal, project planning and organising, developing and running a workshop. Drafting and reviewing subsequent IPD guidance papers |
| Collaborator Contribution | Helping develop the funding proposal, project planning, developing the workshop. Drafting and reviewing subsequent IPD guidance papers. |
| Impact | We brought international experts to the Unit to discuss key IPD topics, develop guidance outlines and establish writing committees. We have published four papers. |
| 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 |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | MRC Hubs for Trials Methodology Research Network funded proposal 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 underway. |
| 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 | Public |
| PI Contribution | MRC Hubs for Trials Methodology Research 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 given from the MRC Hubs for Trials Methodology Research Network . |
| Impact | Two papers have been published and one further paper has been submitted for publication. |
| 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 | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| 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 | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| 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 | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| Start Year | 2013 |
| Description | R39 Agreeing current good practice for clinical trial data access and sharing |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| 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 | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| Start Year | 2013 |
| Description | R39 Agreeing current good practice for clinical trial data access and sharing |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | MRC Hubs for Trials Methodology Research Network funded 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 | MRC Hubs for Trials Methodology Research Network funding provided for project commencement |
| Impact | Two papers published giving views on data sharing, rationale and examples |
| Start Year | 2013 |
| Description | Routine electronic health records (EHR) used as trial data by randomised controlled trials in the UK |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Development of a Protocol for a systematic review, undertaking review activities and manuscript preparation |
| Collaborator Contribution | Guidance and advice on the development of the Protocol, assistance with review activities |
| Impact | Published Protocol at url above |
| Start Year | 2018 |
| Description | Routine electronic health records (EHR) used as trial data by randomised controlled trials in the UK |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Development of a Protocol for a systematic review, undertaking review activities and manuscript preparation |
| Collaborator Contribution | Guidance and advice on the development of the Protocol, assistance with review activities |
| Impact | Published Protocol at url above |
| Start Year | 2018 |
| Description | Show RESPECT study collaboration |
| Organisation | Cancer Research UK |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Leading Show RESPECT study, looking at best ways to disseminate study results to study participants |
| Collaborator Contribution | Members of steering group, helping to design, conduct and disseminate results of study |
| Impact | None yet |
| Start Year | 2017 |
| Description | Show RESPECT study collaboration |
| Organisation | Harvard University |
| Department | Harvard Medical School |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | Leading Show RESPECT study, looking at best ways to disseminate study results to study participants |
| Collaborator Contribution | Members of steering group, helping to design, conduct and disseminate results of study |
| Impact | None yet |
| Start Year | 2017 |
| Description | Show RESPECT study collaboration |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leading Show RESPECT study, looking at best ways to disseminate study results to study participants |
| Collaborator Contribution | Members of steering group, helping to design, conduct and disseminate results of study |
| Impact | None yet |
| Start Year | 2017 |
| Description | Show RESPECT study collaboration |
| Organisation | NHS Health Research Authority |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Leading Show RESPECT study, looking at best ways to disseminate study results to study participants |
| Collaborator Contribution | Members of steering group, helping to design, conduct and disseminate results of study |
| Impact | None yet |
| Start Year | 2017 |
| Description | Show RESPECT study collaboration |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leading Show RESPECT study, looking at best ways to disseminate study results to study participants |
| Collaborator Contribution | Members of steering group, helping to design, conduct and disseminate results of study |
| Impact | None yet |
| Start Year | 2017 |
| Description | TEMPER-related collaboration |
| Organisation | University College Cork |
| Country | Ireland |
| Sector | Academic/University |
| PI Contribution | Coordinating two pieces of work related to (extensions of) the TEMPER monitoring study (run from MRC CTU at UCL, funded by CRUK and MRC) |
| Collaborator Contribution | PhD student at Cork, helping plan, conduct and analyse the two small projects. |
| Impact | None yet |
| Start Year | 2017 |
| Description | Trial 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 methodological research |
| Collaborator Contribution | Expertise and intellectual contribution to push forward some specific areas of trial conduct methodological research |
| Impact | No outcomes to report as yet - collaboration still active |
| Start Year | 2014 |
| Description | Trials methodology research partnership |
| Organisation | Health Data Research UK |
| 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 | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | Cancer Research UK |
| Department | Clinical Trials Unit (CTU) Glasgow |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | Newcastle University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | Queen Mary University of London |
| Department | Barts Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University College London |
| Department | UCL Cancer Institute |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University of Edinburgh |
| Department | Edinburgh Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University of Nottingham |
| Department | Nottingham Clinical Trials Unit (NCTU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | UKCRC Registered CTUs Network: Participant data sharing group |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Member of the working group |
| Collaborator Contribution | Partners are involved in a working group to facilitate the implementation of data sharing good practice across the UKCRC registered CTU network, to provide advice and support to CTUs about data sharing, and to liaise with external organisations regarding data sharing. |
| Impact | No outputs as yet |
| Start Year | 2014 |
| Description | Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) |
| Organisation | Public Health England |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Guidance on study protocol, application for data access |
| Collaborator Contribution | Supervision of PhD, data analysis |
| Impact | Not yet |
| Start Year | 2017 |
| Description | Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Guidance on study protocol, application for data access |
| Collaborator Contribution | Supervision of PhD, data analysis |
| Impact | Not yet |
| Start Year | 2017 |
| Description | Use of routinely collected data for progression and side-effects (PhD related to STAMPEDE) |
| Organisation | University of Warwick |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Guidance on study protocol, application for data access |
| Collaborator Contribution | Supervision of PhD, data analysis |
| Impact | Not yet |
| Start Year | 2017 |
| Title | Show RESPECT |
| Description | The Show RESPECT study is aiming to find practical ways to share the results of clinical trials with the people taking part in it. It is doing this by testing several different approaches within a large ovarian cancer trial (the ICON8 trial). |
| Type | Products with applications outside of medicine |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2018 |
| Development Status | Under active development/distribution |
| Clinical Trial? | Yes |
| Impact | Nil |
| URL | http://www.isrctn.com/ISRCTN96189403 |
| Title | IPDMETAN/ADMETAN: Stata code for two-stage IPD meta-analysis and aggregate data v3.0 |
| Description | IPDMETAN and ADMETAN are components of the same overall package, but can now be installed and updated with reference to either of the two names. This places "admetan" in direct competition with the older "metan" command as Stata's foremost meta-analysis package. |
| Type Of Technology | Software |
| Year Produced | 2018 |
| Impact | IPDMETAN/ADMETAN was downloaded over 200 times per month on average during 2018, and remains the second most popular meta-analysis package, behind "metan". Furthermore, a notable increase was seen in email and forum activity referencing "admetan" over "metan" in the context of performing meta-analysis with Stata. |
| URL | https://www.stata.com/meeting/uk18/ |
| Title | IPDMETAN: Stata code for two-stage IPD meta-analysis v1.0 |
| Description | The Stata package "ipdmetan" comprises a set of routines for conducting two-stage individual participant data (IPD) meta-analysis, and associated functionality. |
| Type Of Technology | Software |
| Year Produced | 2015 |
| 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. A Stata Journal article describing the functionality of the package has been published |
| URL | http://econpapers.repec.org/software/bocbocode/s457785.htm |
| Title | IPDMETAN: Stata code for two-stage IPD meta-analysis v2.0 |
| Description | IPDMETAN v2.0 with the aggregate-data routine, "admetan", and now has the majority of the functionality of the older "metan". In addition, "admetan" is far more likely to run successfully in resource-limited environments than "metan", due to various programming inefficiencies. |
| Type Of Technology | Software |
| Year Produced | 2017 |
| Impact | IPDMETAN was downloaded over 200 times per month on average during 2017, and is now the second most popular meta-analysis package, behind "metan". |
| Description | BBC News - Statistical analysis of Stricly Come Dancing winners |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | PhD student, Susan Connolly, assisted with statistical analysis for BBC News article about predicting the winner of Stricly Come Dancing 2017 (http://www.bbc.co.uk/news/entertainment-arts-41280119 ). Susan's analyis and predictions were mentioned and praised in a subsequent article in Significance magazine (https://www.significancemagazine.com/culture/576-statistical-analysis-strictly-on-request) |
| Year(s) Of Engagement Activity | 2017,2018 |
| URL | https://www.significancemagazine.com/culture/576-statistical-analysis-strictly-on-request |
| Description | BSA Science Discussion Panel |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | PhD student, Susan Connolly, took part in BSA Science Discussion Panel in Edinburgh, debating science, statistics and the media |
| Year(s) Of Engagement Activity | 2017 |
| Description | Discussion group about dissemination of trial results to participants in ovarian cancer trials |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Study participants or study members |
| Results and Impact | Discussion group to talk about experiences of dissemination of trial results from the perspective of participants in ovarian cancer trials. Set up to provide Patient and Public Involvement input into a study about this being designed at MRC CTU. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Discussion of implementing novel clinical trial designs |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Interview with Matt Sydes on Radio 4's World At One to talk about adaptive and novel trial designs. This was organised by MRC Press Office after Jeremy Hunt raised adaptive trials in parliament with reference to Tessa Jowell's comments. This was an opportunity to correct some potential misunderstandings. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Engage conference 2017 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Other audiences |
| Results and Impact | Presented the MRC CTU Patient Information Sheet template at the Engage conference 2017. |
| Year(s) Of Engagement Activity | 2017 |
| URL | https://www.publicengagement.ac.uk/nccpe-projects-and-services/engage-conference |
| Description | Focus group about communicating trial results to trial participants (MRC and CRUK) |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Study participants or study members |
| Results and Impact | A one-day focus group, held by MRC CTU and Cancer Research UK, with people who had participated in a trial or were close to those who have participated. |
| Year(s) Of Engagement Activity | 2017 |
| Description | How are phase III trials in the UK monitored? The story from the registered CTUs |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | A webinar was held with interested research groups from clinical trials units across the UK. including people from funding bodies. We presented the results of our survey on the practices of monitoring at trial units in the UK. Folllowing the webinar there were lots of questions about the next steps and interest from members to contribute to further research in this area. |
| Year(s) Of Engagement Activity | 2019 |
| URL | https://www.methodologyhubs.mrc.ac.uk/resources/webinars/ |
| Description | MRC Festival Workshop on Getting Results Faster for Patients |
| 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 | As part of the Medical Research Council (MRC) Festival of Medical Research, the MRC Clinical Trials Unit at University College London (MRC CTU at UCL) held a half-day workshop exploring how the Unit is working to get faster results and impact from clinical trials. We invited patient representatives involved in our studies, and patient groups who are interested in clinical trials. 30 people from 20 patient groups and various trials attended the workshop, along with around 20 members of MRC CTU at UCL staff. |
| Year(s) Of Engagement Activity | 2016 |
| URL | http://www.ctu.mrc.ac.uk/news/2016/getting_results_faster_workshop_report_010816 |
| 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 | Parliamentary Links Lunch |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Policymakers/politicians |
| Results and Impact | PhD student, Susan Connolly, attended Parliamentary Links Lunch at House of Lords, meeting Daniel Zeicher MP, discussing importance of statistics (organised via RSS Ambassador Scheme) |
| Year(s) Of Engagement Activity | 2017 |
| Description | Survey about experiences of receiving trial results among trial participants |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Study participants or study members |
| Results and Impact | Short survey, disseminated via social media, to find out trial participants' experiences and views about receiving results of trials they take part in. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Twitter Q+A session: #fastertrials #fasterimpact |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Held a Twitter Q+A as part of the MRC Festival of medical research 2016. It focused on how to speed up both the conduct of trials and the impact of these trials' results. |
| Year(s) Of Engagement Activity | 2016 |
| URL | http://www.ctu.mrc.ac.uk/news/2016/faster_trials_qa_230616 |