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.

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.

Organisations

Publications

10 25 50
 
Description Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART I & 2. J Urol 2021; 205: 14. Lowrance WT, Breau RH, Chou R et al:
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical reviews
Impact Improvement in knowledge of prostate cancer treatment. STAMPEDE trial mentioned.
URL https://www.auanet.org/guidelines/advanced-prostate-cancer
 
Description Citation in clinical reviews - APCCC 2019 review and guidelines: STAMPEDE & PR07 (8 papers) (2020)
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical reviews
Impact Improvements in outcomes for patients with prostate cancer https://www.europeanurology.com/action/showPdf?pii=S0302-2838%2820%2930048-8
URL https://www.ncbi.nlm.nih.gov/pubmed/32063029
 
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
 
Guideline Title Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Description ESMO Clinical Practice Guidelines - Prostate Cancer
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
Impact Published in 2020 - Ann Oncol (2020) Authors: C. Parker, E. Castro, K. Fizazi, A. Heidenreich, P. Ost, G. Procopio, B. Tombal & S. Gillessen Prostate cancer is reported as the second most common cancer in men. The updated ESMO Clinical Practice Guidelines on prostate cancer provide information on the current management of prostate cancer including recommendations for screening and diagnosis, along with stage-matched therapeutic strategies.
URL https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2820%2939898-7
 
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 Influence on MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions
Geographic Reach National 
Policy Influence Type Citation in other policy documents
Impact MHRA update guidlines to say: "5. Examples of scenarios, endpoints and designs Noting the points above, an example of a suitable scenario for a RWD based trial and an appropriate design would be: [Truncated] An objective endpoint routinely and consistently collected in the EHR database(s) for the patient population considered of interest. For example, all-cause mortality and inpatient hospitalisations are known to be well recorded in the UK general population. Disease specific outcomes may require assessment within the proposed study population (e.g., HbA1c is known to be well recorded in primary care for the diabetic population, but less so for the general population)" [Truncated] Mention of HES APC and Death datasets is taken directly from our work and discussions with MHRA in Jul-2021, Oct-2021 and our discussions around these points, including their commenting on our report. They have put out this information without attribution to our work (we have asked for an update) and before our report was made public on https://zenodo.org/record/6047155
URL https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-s...
 
Description National Comprehensive Cancer Network (NCCN) Guidelines in Oncology; Prostate Cancer v.3.0, Nov. 17th 2020 - radiation therapy guidelines.
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact Low volume metastatic disease: Radiation therapy to the prostate is an option in patients with low-volume castration naive metastatic disease, without contraindications to radiotherapy. ADT is required unless medically contraindicated. This recommendation is based on the STAMPEDE phase 3 randomized trial, which randomized 2,061 men to standard systemic therapy with or without radiotherapy to the primary. The overall cohort had a significant improvement from the addition of radiotherapy to the primary in failure-free survival, but not overall survival. The pre-specified low-volume subset had a significant improvement in both failure-free survival and overall survival.
URL https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_g...
 
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 Prostate Cancer 2020 Guidelines European Association of Urology (EAU) - STAMPEDE trial cited.
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical reviews
Impact Enhancing knowledge in treatment best practice of prostate cancer.
URL https://uroweb.org/guideline/prostate-cancer/#6_3
 
Description Update HRA review of platform protocols (REC Member Information Exchange 32 - June 2021)
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Health Research Authority newsletter sets out new processes to 852 members (including lay members) of UK Research Ethics Committeees (RECs). Text below: ================================ REC Member Information Exchange 32 - June 2021 == Contents Page == [removed] 5. Complex Innovative Design Trials [removed] == 5. Complex Innovative Design trials == A "Complex Innovative Design" trial is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. These trials are also sometimes referred to as platform, adaptive or umbrella trials. Trials in this Complex Innovative Design family can offer flexible features such as stopping recruitment early to treatments which are not being active enough, or adding new research questions (comparisons) to be evaluated during the course of a trial. These trials, like many clinical trials, may be able to declare early that one or more treatments are superior. These issues need to be thought about carefully by the trial team before the trial starts. Many of you will have attended one of five workshops ran by Matt Sydes and Louise Brown from the MRC Clinical Trials Unit at UCL as part of the programme for the Regional REC member training days held across 2019 and 2020. The sessions led by Matt and Louise involved presentations on the benefits and challenges of adding comparisons into ongoing protocols and guided group discussions on issues specific to the ethics review. Since the regional training days, Matt and Louise have collated and reviewed the feedback from REC members who attended the workshops and have continued to work with the HRA and provide valuable input in terms of the ethics review process for Complex Innovative Design trials. During the last year, a number of COVID-19 trials have used complex, innovative designs and therefore, more RECs will have now started reviewing such trials. It is likely that this type of trial design will continue to be used more frequently due to the benefits of utilising an adaptive approach. We would like to take this opportunity to provide members with an update on the actions which have been taken forward since the regional training days: REC Members agreed that it needed to be clearer at the outset whether a study was a Complex Innovative Design trial. There will be a question in the new version of IRAS to flag this type of trial - this is already live for CTIMPs using the new application form for Combined Ways of Working. Feedback from members was that they were sometimes concerned about reviewing substantial amendments to Complex Innovative Design trials due to the scale of the changes involved in the amendment (e.g. introducing a new arm). A revised version of the Standard Operating Procedures for Research Ethics Committees was published in March and included the following paragraph to remind members that a new application should not be requested in these instances but that the Sub-Committee may involve more members in the review of the amendment if they considered that wider consultation would be helpful: 'By virtue of their design, studies which have been set up as Complex Innovative Design trials (sometimes referred to as adaptive, platform or umbrella trials) may add different interventions or may recruit new categories of participants as the study progresses. For Complex Innovative Trials, it is acceptable for these changes to be submitted as a substantial amendment rather than as a new application. However, for trials to come under the heading of a Complex Innovative Trial, the protocol must have been approved by the REC on this basis when the study was originally reviewed and the methodology included in the protocol should have been clear about the scope for future phases, treatment arms or other adaptive features. Where the changes included in the amendment are particularly significant, the amendment may be reviewed by a Sub-Committee involving a larger number of members or by reviewing the amendment at a full REC meeting' In addition to the above, REC members should also request the member of staff supporting their REC to contact the MHRA Medical Assessor if there is an aspect related to the safety or clinical evidence which they are unsure about when reviewing the amendment REC Members who attended the workshops requested further training in how to ethically review Complex Innovative Design trials. There is now a series of podcasts which members can access, including one specifically directed at REC members. We are also hoping to include a Complex Innovative Design trial in one of our focussed discussion workshops for members to debate. REC Members stipulated that the clarity of the description of the amendment was important and the changes needed to be presented as succinctly as possible. The following suggestions were agreed and we will be looking at how best to encourage applicants to present information in this way as part of their substantial amendment: • An updated trial schema indicating how the trial has changed from the previous version. • A clear covering letter which should include a statement of whether a new comparison (with a new research arm) has been added. • A short form highlighting the documents impacted by the proposed amendment) and clarity on who has already scientifically peer-reviewed these changes. We would like to take this opportunity to express our thanks to Matt and Louise for the work which they have undertaken with the HRA and with REC members in delivering the training and helping us take these initiatives forward.
 
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 04/2012 
End 05/2016
 
Description Clinical Trials Advisory and Awards Committee (CTAAC) -- STAMPEDE
Amount £1,500,000 (GBP)
Funding ID CRUK/06/019 [A3804] 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2006 
End 04/2026
 
Description Clovis Oncology start-up grant
Amount £500,000 (GBP)
Organisation Clovis Oncology, inc 
Sector Private
Country United States
Start 12/2016 
End 11/2018
 
Description Health Data Research (UK) funding
Amount £202,717 (GBP)
Organisation Health Data Research UK 
Sector Private
Country United Kingdom
Start 09/2018 
End 10/2021
 
Description Home delivery of STAMPEDE Abiraterone/Enzalutamide drug to participants during Covid-19 pandemic (Janssen/Astellas funded)
Amount £12,120 (GBP)
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 03/2020 
End 06/2021
 
Description Investigator initiated study (Janssen) -- STAMPEDE
Amount £1,850,000 (GBP)
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 09/2011 
End 12/2021
 
Description Janssen access to STAMPEDE data (funding for MRC CTU through UCLB)
Amount £1,461,021 (GBP)
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 01/2010 
End 09/2011
 
Description MRC Hub for Trials Methodology Research (HTMR) - extension
Amount £500,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 03/2014 
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 Public
Country United Kingdom
Start 08/2016 
End 08/2019
 
Description QualShare - Irish HBR Trials Methodology call
Amount € 10,000 (EUR)
Funding ID QualShare 
Organisation Trials Methodology Research Network 
Sector Private
Country Ireland
Start 03/2021 
End 04/2022
 
Description SPIRIT-EHR
Amount € 10,000 (EUR)
Organisation Trials Methodology Research Network 
Sector Private
Country Ireland
Start 03/2021 
End 04/2022
 
Description STAMPEDE Sanofi visit 19-20 July 2017 to evaluate the trial conduct, data structure, database, clinical quality, and data validation processes; plus follow-up actions (UCLC)
Amount £27,312 (GBP)
Organisation Sanofi 
Sector Private
Country Global
Start 06/2017 
End 06/2022
 
Description STAMPEDE: abiraterone comparison - bone scan sub-study for arm G comparison additional sub-study and funding
Amount £465,982 (GBP)
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 11/2017 
End 06/2022
 
Description STRATOSPHERE grant
Amount £1,440,000 (GBP)
Organisation Prostate Cancer UK 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2018 
End 03/2021
 
Description Sanofi access to regulatory licensing report - (funding for MRC CTU through UCLB)
Amount £275,000 (GBP)
Organisation Sanofi 
Sector Private
Country Global
Start 01/2017 
End 12/2020
 
Description Sustainable clinical trials -- NIHR CTU efficiency call
Amount £76,284 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 08/2021 
End 09/2022
 
Description Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) - Biomarker analysis
Amount £146,883 (GBP)
Organisation Clovis Oncology, inc 
Sector Private
Country United States
Start 03/2016 
End 09/2020
 
Description Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) - Inclusion SAKK (Swiss coordinating centre). JANSSEN grant.
Amount £25,000 (GBP)
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 03/2012 
End 09/2021
 
Description Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) "Enzalutamide + Abiraterone Comparison". ASTELLAS award.
Amount £3,100,000 (GBP)
Organisation Astellas Pharma 
Sector Private
Country Japan
Start 03/2014 
End 06/2022
 
Title Considerations for a Participant Data Sharing SOP 
Description Report: published guideline with UKCRC 
Type Of Material Improvements to research infrastructure 
Year Produced 2021 
Provided To Others? Yes  
Impact Not known 
URL https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf
 
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 Monitoring of clinical trials : a handbook 
Description The monitoring handbook is aimed at UK academic trialists undertaking monitoring activities such as on-site, remote and central monitoring. It is intended to be used as a resource to support initial training of those performing monitoring activities and as a point of reference thereafter. The handbook provides general information about monitoring, which should be supported by training on CTU/Sponsor specific SOPs, guidance documents and templates. This handbook provides information on the theory of monitoring, tips on conduct and real-life examples and exercises that may help to explain and support possible monitoring approaches and their application. 
Type Of Material Improvements to research infrastructure 
Year Produced 2021 
Provided To Others? Yes  
Impact It had 30 downloads in the first day of launch 
URL https://ukcrc-ctu.org.uk/guidance-for-ctus/
 
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 Systematic review of the prevalence and assessment of language-related eligibility criteria in patient recruitment to type 2 diabetes and depression trials. 
Description Published research protocol for ongoing work 
Type Of Material Improvements to research infrastructure 
Year Produced 2021 
Provided To Others? Yes  
Impact Not known 
 
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/
 
Title STAMPEDE monitoring data for Alan Turing Institute Data Study Group Challenge 
Description Dataset about and around data from STAMPEDE trial, constructured so participants of Alan Turing Institute Data Study Group Challenge could investigate 
Type Of Material Database/Collection of data 
Year Produced 2021 
Provided To Others? Yes  
Impact None yet. Not publicly available. 
 
Description "PROUD to have been involved": an evaluation of participant and community involvement in the PROUD HIV prevention trial 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Members of the research team were responsible for study design, designing participant surveys, analysis and writing manuscript
Collaborator Contribution Partners provided advice throughout the project, and commented on the final manuscript. They were also involved in PROUD as community representatives or actively involved participants.
Impact 1 paper (PMID: 32322408)
Start Year 2018
 
Description "PROUD to have been involved": an evaluation of participant and community involvement in the PROUD HIV prevention trial 
Organisation NAM: Aidsmap
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Members of the research team were responsible for study design, designing participant surveys, analysis and writing manuscript
Collaborator Contribution Partners provided advice throughout the project, and commented on the final manuscript. They were also involved in PROUD as community representatives or actively involved participants.
Impact 1 paper (PMID: 32322408)
Start Year 2018
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation Dana-Farber Cancer Institute
Country United States 
Sector Hospitals 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation Duke University
Country United States 
Sector Academic/University 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation European Organisation for Research and Treatment of Cancer (EORTC)
Country Belgium 
Sector Charity/Non Profit 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation Harvard University
Country United States 
Sector Academic/University 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation University of Chicago
Country United States 
Sector Academic/University 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses 
Organisation University of Hasselt
Department International Drug Development Institute
Country Belgium 
Sector Academic/University 
PI Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Collaborator Contribution This review evaluated the reporting quality of published meta-analyses on surrogacy evaluation and developed recommendations for future reporting
Impact Publication of results https://doi.org/10.1093/jncics/pkz002
Start Year 2017
 
Description Add-Aspirin PHE routine data work 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution Use of data from the Add-Aspirin clinical trial, for methodological work to assess the quality and completeness of routinely collected healthcare data, when compared with data collected within a clinical trial.
Collaborator Contribution Provision of routinely collected healthcare data from a number of linked databases.
Impact None as yet
Start Year 2019
 
Description Alan Turing Institute and AI 
Organisation Alan Turing Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution This collaboration is in two parts: clinical trial monitoring, and treatment effect heterogeneity. 1. We have described the problems in monitoring of clinical trial data. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. 2. For the treatment effect heterogeneity project, we are supplying our expertise on treatment effect estimation in clinical trials, new work on performance measures for treatment effect heterogeneity, and data from a trial in treatmnet of severe anaemia in African children
Collaborator Contribution Scientists of the Alan Turing Institute are using AI including ML on our clinical trial data and on simulated data to find out what methods can be used in the two settings above. A data study group has been run on the monitoring project (entered separately in Research Fish).
Impact A data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem.
Start Year 2019
 
Description Alan Turing Institute and AI 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution This collaboration is in two parts: clinical trial monitoring, and treatment effect heterogeneity. 1. We have described the problems in monitoring of clinical trial data. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. 2. For the treatment effect heterogeneity project, we are supplying our expertise on treatment effect estimation in clinical trials, new work on performance measures for treatment effect heterogeneity, and data from a trial in treatmnet of severe anaemia in African children
Collaborator Contribution Scientists of the Alan Turing Institute are using AI including ML on our clinical trial data and on simulated data to find out what methods can be used in the two settings above. A data study group has been run on the monitoring project (entered separately in Research Fish).
Impact A data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem.
Start Year 2019
 
Description Alan Turing Institute and AI - Data Study Group 
Organisation Alan Turing Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution We have described the problems in monitoring of clinical trial data. Phase III clinical trials are typically multicentre (50-200 sites) and recruit several hundred patients (300-10000). ICH GCP E6(R2) say "Clinical trialists monitor trial data in order to protect the rights and well-being of participants, to ensure that the trial data are accurate, complete, and verifiable, and to confirm that the trial is being run in compliance with the currently approved protocol, with the principles of good clinical practice (GCP), and with the relevant regulatory requirements". This monitoring can take 25% of the CTU trial budget. With risk based monitoring, we consider the risks to the patients and the trial and devise the monitoring to reduce or mitigate these risks. It may be more efficient to use AI (or ML) to look at the full dataset and find what data areas and sites we need to target, rather than use our ideas of risk and solution. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI.
Collaborator Contribution ATI will provide funding for project work for the week. Scientists of the Alan Turing Institute will use AI including ML on our clinical trial data to find out what data areas and sites we need to approach to improve the clinical trial data. We will have monitoring experts from the clinical trials unit on hand to give any explanations required and check the process is on track.
Impact The data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. A report is currently being written.
Start Year 2021
 
Description Alan Turing Institute and AI - Data Study Group 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution We have described the problems in monitoring of clinical trial data. Phase III clinical trials are typically multicentre (50-200 sites) and recruit several hundred patients (300-10000). ICH GCP E6(R2) say "Clinical trialists monitor trial data in order to protect the rights and well-being of participants, to ensure that the trial data are accurate, complete, and verifiable, and to confirm that the trial is being run in compliance with the currently approved protocol, with the principles of good clinical practice (GCP), and with the relevant regulatory requirements". This monitoring can take 25% of the CTU trial budget. With risk based monitoring, we consider the risks to the patients and the trial and devise the monitoring to reduce or mitigate these risks. It may be more efficient to use AI (or ML) to look at the full dataset and find what data areas and sites we need to target, rather than use our ideas of risk and solution. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI.
Collaborator Contribution ATI will provide funding for project work for the week. Scientists of the Alan Turing Institute will use AI including ML on our clinical trial data to find out what data areas and sites we need to approach to improve the clinical trial data. We will have monitoring experts from the clinical trials unit on hand to give any explanations required and check the process is on track.
Impact The data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. A report is currently being written.
Start Year 2021
 
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 Clinical Trials Transformation Initative (CTTI) project group on platform protocols 
Organisation Novartis
Department Clinical Trials
Country Switzerland 
Sector Private 
PI Contribution Invited (SL, LB) to join working group for addressing pressing issues in platform protocols for clinical trials
Collaborator Contribution CTTI leading; other groups participating.
Impact (None yet)
Start Year 2019
 
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 Comparison of aggregate and individualUi participant data approaches to meta-analysis of randomised trials: An observational study 
Organisation University of York
Country United Kingdom 
Sector Academic/University 
PI Contribution Members of the research team were responsible for project development, methodology development, analysis, interpretation of results and writing manuscript
Collaborator Contribution Partners provided advice throughout the project, helped interpret the results and helped write manuscript
Impact 1 paper (PMID: 32004320)
Start Year 2015
 
Description Data sharing for qualitative data for clinical trials 
Organisation National University of Ireland, Galway
Country Ireland 
Sector Academic/University 
PI Contribution 10,000 Euro grant to NUI Galway to research in the topic from Irish HRB Trials Methodology Research Network. To explore issues in data sharing from clinical trials where qualitative data have been collected.
Collaborator Contribution Led from NUI Galway
Impact None yet
Start Year 2020
 
Description Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials 
Organisation University of Nottingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Members of the research team were responsible for all analyses, contributed to the study design, interpretation of results and reviewed and approved the final manuscript
Collaborator Contribution Partners conceived the idea, contributed to the study design, interpretation of results and drafted and reviewed and approved the final manuscript
Impact 1 paper (PMID: 32522228)
Start Year 2019
 
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 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 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 Education (for 1500+ medics) at 2020 Genitourinary Cancers Symposium #GU20 
Organisation American Society for Radiation Oncology American Society Radiation Oncology
Country United States 
Sector Learned Society 
PI Contribution (MSy) Ran education session at #GU20 in San Francisco to >1500 people. Very well received. May lead to future collaboration on education.
Collaborator Contribution Ran education session on clinical trials at major international single-stream conference on basic (and necessary) info around dealing with clinical trials data. Audience >1500 people.
Impact https://meetinglibrary.asco.org/record/180801/video
Start Year 2019
 
Description Education (for 1500+ medics) at 2020 Genitourinary Cancers Symposium #GU20 
Organisation American Society of Clinical Oncology (ASCO)
Country United States 
Sector Learned Society 
PI Contribution (MSy) Ran education session at #GU20 in San Francisco to >1500 people. Very well received. May lead to future collaboration on education.
Collaborator Contribution Ran education session on clinical trials at major international single-stream conference on basic (and necessary) info around dealing with clinical trials data. Audience >1500 people.
Impact https://meetinglibrary.asco.org/record/180801/video
Start Year 2019
 
Description Education (for 1500+ medics) at 2020 Genitourinary Cancers Symposium #GU20 
Organisation Society of Urologic Oncology
Country United States 
Sector Learned Society 
PI Contribution (MSy) Ran education session at #GU20 in San Francisco to >1500 people. Very well received. May lead to future collaboration on education.
Collaborator Contribution Ran education session on clinical trials at major international single-stream conference on basic (and necessary) info around dealing with clinical trials data. Audience >1500 people.
Impact https://meetinglibrary.asco.org/record/180801/video
Start Year 2019
 
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 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 Healthcare systems data for clinical trials: data integrity 
Organisation NHS Digital
Country United Kingdom 
Sector Public 
PI Contribution Leadership of project and coordination
Collaborator Contribution Discussion, data, engagement
Impact Work ongoing but includes https://zenodo.org/record/6047155#.YiXW1fnP2Uk
Start Year 2021
 
Description Healthcare systems data for clinical trials: data integrity 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Leadership of project and coordination
Collaborator Contribution Discussion, data, engagement
Impact Work ongoing but includes https://zenodo.org/record/6047155#.YiXW1fnP2Uk
Start Year 2021
 
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 Improving review of platfom protocols by Health Research Authority and Research Ethics Committees 
Organisation NHS Health Research Authority
Country United Kingdom 
Sector Public 
PI Contribution Provided (MSy, LB) 1 hour training-and-discussion session at 5 regional meetings for HRA (Leicester, Leeds, Oxford in 2019 and London and Manchester in 2021) on implementation on platform protocols and challenges in ethics review when clinical trial questions are added to an ongoing protocol. Proposed guidance on reviewing of platform protocols presented to HRA in Mar-2021.
Collaborator Contribution Organisation of meetings and invitation of attendees (REC members)
Impact Draft guidance developed by MRC CTU and presented to HRA on improving review of platform protocols. Too recent for impact.
Start Year 2019
 
Description International Clinical Trials and Methodology Conference 2019 (#ICTMC2019) 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution CTU (MSy) chaired Scientific Committee for ICTMC 2019. This is the largest clinical trials methodology conference with >800 attendees. CTU (MP) originally proposed the conference and chaired the first, every-other-year conference in 2011.
Collaborator Contribution Other partners joined the Scientific and Education committees.
Impact Successfully and very well attended clinical trials methodology conference
Start Year 2018
 
Description Language for trial consent 
Organisation University College London
Department Institute of Education (IOE)
Country United Kingdom 
Sector Academic/University 
PI Contribution Led by Talia Isaacs at UCL IOE. Grant to Talia for £10K to support improvements in language around recruitment to clinical trials. CTU provide some motivating examples. Also input from University of Aberdeen; University College Cork; HRB Trials Methodology Research Network Ireland; National University Ireland, Galway; Dartmouth College; and University of Leicester
Collaborator Contribution Work starting Mar-2021
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation NHS Digital
Country United Kingdom 
Sector Public 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation Queen's University Belfast
Country United Kingdom 
Sector Academic/University 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
Description MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support.
Collaborator Contribution Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements.
Impact None yet
Start Year 2021
 
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 Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation Biomedical Research Centre Network for Epidemiology and Public Health
Country Spain 
Sector Public 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation Instituto de Investigación Biosanitaria
Country Spain 
Sector Public 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation Stanford University
Country United States 
Sector Academic/University 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation University of Granada
Country Spain 
Sector Academic/University 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description Methods used to assess outcome consistency in clinical studies: A literature-based evaluation 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Members of the Research Team were responsible for conceptualization, data curation, analysis, methodology, project administration and writing, reviewing and editing the final manuscript
Collaborator Contribution Helped with conceptualization and data curation, provided methodological advice and helped write manuscript
Impact 1 protocol and 1 paper (PMID: 32639999)
Start Year 2019
 
Description NHS Digital collaboration 
Organisation Health & Social Care Information Centre (HSCIC)
Country United Kingdom 
Sector Public 
PI Contribution Strategic and collaborative input
Collaborator Contribution Strategic and collaborative input
Impact (None yet)
Start Year 2020
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation Association of the British Pharmaceutical Industry
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Public 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation National Institute for Health Research
Country United Kingdom 
Sector Public 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR Task and Finish group for data sharing 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated.
Collaborator Contribution Part of group
Impact Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf
Start Year 2015
 
Description NIHR Task and Finish group for data sharing 
Organisation UKCRC Registered trials CTU network
Country United Kingdom 
Sector Academic/University 
PI Contribution Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated.
Collaborator Contribution Part of group
Impact Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf
Start Year 2015
 
Description NIHR Task and Finish group for data sharing 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated.
Collaborator Contribution Part of group
Impact Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf
Start Year 2015
 
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 ORRCA2 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Screening of abstracts to form the database for this project
Collaborator Contribution Initiating and management of this project. Many UK-wide partner organisations.
Impact Website for use to support research
Start Year 2018
 
Description PERSEVERE 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Hosted first meeting of PERSEVERE group to consider issues around premature stopping of participation to clinical trials. CTU joined a number of small, short-term working parties, subsequently. Nationwide input.
Collaborator Contribution Ex-CTU employee now at Leeds proposed the project
Impact (None yet)
Start Year 2019
 
Description PRISMA-IPD Steering Group 
Organisation Queen's University Belfast
Department MRC All-Ireland Methodology Hub
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 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
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 PhD student in electronic health records 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution Developing PhD proposal and primary supervision (JC) and secondary supervision (MS, SL)
Collaborator Contribution One secondary supervisor is from ICR (NJ) and one from Birmingham (HM)
Impact Published protocol -- see outputs ("Registered systmatic review: Monitoring strategies for clinical intervention studies")
Start Year 2020
 
Description PhD student in electronic health records 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Developing PhD proposal and primary supervision (JC) and secondary supervision (MS, SL)
Collaborator Contribution One secondary supervisor is from ICR (NJ) and one from Birmingham (HM)
Impact Published protocol -- see outputs ("Registered systmatic review: Monitoring strategies for clinical intervention studies")
Start Year 2020
 
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 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 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 Academic/University 
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 Belgium 
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 SPIRIT-Routine 
Organisation University College Cork
Country Ireland 
Sector Academic/University 
PI Contribution 10,000 Euro grant from Irish HRB Trials Methodology Research Network to UC Cork to develop extension to SPIRIT (Standard Protocol Items for Randomised Trials) checklist for clear use of routinely collected health data (RCHD). CTU on committee. Many other universities involved.
Collaborator Contribution None yet
Impact None yet
Start Year 2021
 
Description Secondment to NHS Digital 
Organisation NHS Digital
Country United Kingdom 
Sector Public 
PI Contribution expertise and intellectual input
Collaborator Contribution expertise and intellectual input
Impact outputs expected 2021
Start Year 2020
 
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 TMRP TCWG Data Quality and Monitoring topic group 
Organisation University of Nottingham
Department Nottingham Clinical Trials Unit (NCTU)
Country United Kingdom 
Sector Academic/University 
PI Contribution leadership, expertise and intellectual input
Collaborator Contribution expertise and intellectual input
Impact outputs paper submitted mulitdisciplinary - trial statisticians, trial managers, data managers, data scientists, researchers
Start Year 2020
 
Description Task and Finish Monitoring Group 
Organisation UK Clinical Research Collaboration
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Leadership, expertise and intellectual input
Collaborator Contribution expertise and intellectual input
Impact paper DOI: 10.1186/s13063-021-05225-5, handbook of monitoring available at ukcrc-ctu.org.uk/guidance-for-ctus/ multidisciplinary - researchers, data scientists, trial managers, monitors
Start Year 2019
 
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
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 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 Public 
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 UKCRC Task and Finish Group for Monitoring 
Organisation UK Clinical Research Collaboration
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Initiated and developed the nationwide monitoring group
Collaborator Contribution Will bring nationwide experience and engagement on future projects
Impact (None yet)
Start Year 2019
 
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 CDSA Webinar series - Digital Solutions for Clinical Trials/Studies in the Pandemic World 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Run by Clinical Development Services Agency, India, this was a series of workshops chaired by Usha Menon to introduce digital platforms for more efficient running of trials.
Year(s) Of Engagement Activity 2020
 
Description Capacity Strengthening and Training: Presentation on trial conduct methodology to ASCO IDEA Forum (Future Leaders forum) in Low and Middle Income Countries 
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 Capacity Strengthening and Training: Invited presentation at ASCO IDEA cohort workshop for career-young oncologists in low and middle income countries to explain the importance of methodology research to improve future clinical trials, particularly trial conduct methodology. Too recent to know impact.
Year(s) Of Engagement Activity 2021
URL https://www.asco.org/research-guidelines/grants-awards/funding-opportunities/international-developme...
 
Description Capacity Strengthening and Training: Presentation on trial conduct methodology to NIHR Future Leaders forum 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Capacity Strengthening and Training: Invited presentation at NIHR Future Leaders forum for Clinical Research Fellows to explain the importance of methodology research to improve future clinical trials, particularly trial conduct methodology. A number of approaches afterwards from the students.
Year(s) Of Engagement Activity 2020
URL https://spark.adobe.com/page/uKl3QjoDlV0Bd/
 
Description Clinical Trial Data Sharing Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This was a cross-funder (Wellcome, BMGF, CRUK, and MRC) jointly hosted one-day workshop, to discuss advances and opportunities in the clinical trial data sharing landscape. It focused on what activities the funders should support to drive the research they fund to be open and accessible, and to have the greatest possible impact.
The workshop featured invited presentations and discussion to prioritise activities that would best support the research community around four broad themes:
1. Funding services (e.g. different platforms/repository models, tools for curation/data management)
2. Developing models for credit/incentives to share (e.g. recognising data sharing as an important research output)
3. Guidance on how/where to share (e.g. anonymisation, informed consent, models of access)
4. Policies (e.g. mandatory sharing as a grant requirement)
Year(s) Of Engagement Activity 2019
 
Description Clinical Trial Monitoring Webinar 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 200 people interested in or responsible for clinical trial monitoring attended the 4 hour workshop
Year(s) Of Engagement Activity 2021
 
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 Discussion sessions with MHRA about data integrity of healthcare systems data 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Two-part discussions about how to demonstrate data integrity for healthcare systems datasets held by NHS Digital. Has led to report, MHRA updating position and future research.
Year(s) Of Engagement Activity 2021
 
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 External blog championing our recommendations on ethics review of trials looking at multiple primary research hypotheses 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact External blog by previous lead of UK Health Research Authority championing our recommendations for better review, by ethics committees, of trials looking at multiple primary research hypotheses
Year(s) Of Engagement Activity 2021
URL http://www.reviewingresearch.com/platform-trials/
 
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 MHRA Workshops on Routinely-Collected Health Data for clinical trials 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact First workshop Dec-2020. Second workshop Mar-2021. Outputs pending. Should feed into future guidelines.
Year(s) Of Engagement Activity 2020,2021
 
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 NIHR #Innovative Trials Podcast 
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 Professional Practitioners
Results and Impact Podcast episode about sharing information with patients in platform protocols. Part of NIHR series on platform protocols.
Year(s) Of Engagement Activity 2021
URL https://soundcloud.com/nihr/prof-matt-sydes
 
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 PPIE event for DigiTrials, hosted by Kat Arney 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact PPIE event for DigiTrials, hosted by Kat Arney, Dr Macey Murray was interviewed as a trialist working with NHS DigiTrials
Year(s) Of Engagement Activity 2020
 
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 Participation in an activity workshop or similar - NHS R&D Forum annual meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 60 NHS Research and Development departments attended my talk on trial monitoring during COVID which raised awareness of changes and possibilities
Year(s) Of Engagement Activity 2020
 
Description Presentation on implementation of platform protocols at WHO IMPAACT workshop on post-natal prophylaxis 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Workshop of professions and patients to reach design for future trial. Presented an implementation expert on one of the approaches being considered.
Year(s) Of Engagement Activity 2021
 
Description Presentations and panel members at Patient Engagement Open Forum (PEOF) 2021 -- co-project organized by PFMD, EUPATI and European Patients' Forum (EPF) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Matt Sydes and Nuru Noor presented examples of involving patients in platform protocols at the PEOF 2021 online conference. More than 2000 people registered for the conference from multiple continents. Uncertain how many joined this parallel session.
Year(s) Of Engagement Activity 2021
URL https://patientengagement.synapseconnect.org/resources/peof-2021-patient-engagements-needs-in-platfo...
 
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 Training Research Ethics Committees on the issues in platform protocols 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation by M Sydes on Education and training: platform protocols and RECs at EFPIA meeting on Complex Clinical Trials. Aimed at people who sit or or engage with Research Ethics Committees.
Year(s) Of Engagement Activity 2021
URL https://www.efpia.eu/media/636521/day-2-s2-bo6-master-v2.pdf
 
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
 
Description ZOE COVID Symptom Study webinar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact 2ZOE COVID Symptom Study webinar: Ask the Experts: Rolling out COVID-19 Vaccines (09 Dec 2020; public engagement event).
Year(s) Of Engagement Activity 2020
URL https://www.youtube.com/watch?v=RFucRBhp9DU