Effective and efficient conduct of trials and meta-analyses
Lead Research Organisation:
University College London
Abstract
Our work in this area involves investigating and improving trial data checking and monitoring, as well as reducing bias and improving the validity of our systematic reviews. Some of the important outcomes are:
Evidence-based trial monitoring
• Many trials organisations have implemented trial management and monitoring procedures out of proportion to the risks to trial participants or the public, thereby increasing the workload, complexity and cost of lower-risk trials. We initiated the TEMPER study to evaluate prospectively whether triggered monitoring is effective at distinguishing problem sites in ongoing CTU multicentre cancer trials.
Increasing participant retention in trials
• Our systematic review of strategies to increase participant retention specifically in RCTs has shown that monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Non-monetary incentives, additional communication and reminder strategies and most modified questionnaires have little impact.
Informing systematic review conduct
• CTU is leading a Network-funded project to develop a ‘state of the art’ series of papers on Individual participant data (IPD) meta-analyses and recently hosted a workshop of international experts to discuss topics. Most systematic reviews now assess risk of bias of eligible trials based on their publications (often using the Cochrane Collaboration tool), and it has been proposed that these are used as a basis for including or weighting trials in a meta-analysis. An evaluation of publication-based assessments showed that they can be unreliable, compared to those based on information obtained from investigators or protocols (as part of our IPD meta-analyses). In particular, reviewers should be cautious about using these as a basis for trial inclusion, and instead seek additional information from trialists, where possible.
Evidence-based trial monitoring
• Many trials organisations have implemented trial management and monitoring procedures out of proportion to the risks to trial participants or the public, thereby increasing the workload, complexity and cost of lower-risk trials. We initiated the TEMPER study to evaluate prospectively whether triggered monitoring is effective at distinguishing problem sites in ongoing CTU multicentre cancer trials.
Increasing participant retention in trials
• Our systematic review of strategies to increase participant retention specifically in RCTs has shown that monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Non-monetary incentives, additional communication and reminder strategies and most modified questionnaires have little impact.
Informing systematic review conduct
• CTU is leading a Network-funded project to develop a ‘state of the art’ series of papers on Individual participant data (IPD) meta-analyses and recently hosted a workshop of international experts to discuss topics. Most systematic reviews now assess risk of bias of eligible trials based on their publications (often using the Cochrane Collaboration tool), and it has been proposed that these are used as a basis for including or weighting trials in a meta-analysis. An evaluation of publication-based assessments showed that they can be unreliable, compared to those based on information obtained from investigators or protocols (as part of our IPD meta-analyses). In particular, reviewers should be cautious about using these as a basis for trial inclusion, and instead seek additional information from trialists, where possible.
Technical Summary
There is an urgent need for new methods for many clinical studies. One challenge is finding cost-effective, evidence-based methods for running trials. This increases the likelihood of producing reliable results in a timely manner, which in turn frees resources to allow more trials to take place. We will do this by developing and evaluating methods for ensuring that trials are run effectively and efficiently. We are providing practical examples of how novel designs can be implemented; evaluating and implementing strategies to ensure that data quantity and quality are maximised and that staff time locally and at sites is best used. We are also investigating how to get trials started and reported more quickly, and to make appropriate use of e-health resources.
Gains from efficient conduct may be dissipated or lost completely if evidence synthesis of trials is protracted, inefficient or poorly conducted. Furthermore, if understanding or use of systematic reviews is limited, then clinical practice and research may not be informed by the best evidence. We will address these issues by developing a new framework for meta-analysis to speed up the evaluation of individual therapies; providing tools and guidance to promote greater awareness, understanding and use of IPD meta-analysis across a variety of stakeholders and resolving outstanding issues in systematic review conduct.
Gains from efficient conduct may be dissipated or lost completely if evidence synthesis of trials is protracted, inefficient or poorly conducted. Furthermore, if understanding or use of systematic reviews is limited, then clinical practice and research may not be informed by the best evidence. We will address these issues by developing a new framework for meta-analysis to speed up the evaluation of individual therapies; providing tools and guidance to promote greater awareness, understanding and use of IPD meta-analysis across a variety of stakeholders and resolving outstanding issues in systematic review conduct.
Organisations
- University College London, United Kingdom (Collaboration, Lead Research Organisation)
- University of Hasselt, Belgium (Collaboration)
- European Organisation for Research and Treatment of Cancer (EORTC) (Collaboration)
- UKCRC Registered trials CTU network (Collaboration)
- University of Edinburgh, United Kingdom (Collaboration)
- Amgen Inc (Collaboration)
- Instituto de Investigación Biosanitaria (Collaboration)
- University of Sydney, Australia (Collaboration)
- Newcastle University, United Kingdom (Collaboration)
- Association of the British Pharmaceutical Industry (Collaboration)
- Keele University, United Kingdom (Collaboration)
- National Cancer Registration and Analysis Service (Collaboration)
- Harvard University (Collaboration)
- University of Liverpool, United Kingdom (Collaboration)
- AstraZeneca plc (Collaboration)
- Stanford University, United States (Collaboration)
- University of Nottingham (Collaboration)
- Saarland University, Germany (Collaboration)
- UK Trial Managers Network (Collaboration)
- University of Oxford, United Kingdom (Collaboration)
- Health & Social Care Information Centre (HSCIC) (Collaboration)
- Hub at the MRC/CRUK/BHF Clinical Trial Service Unit (Collaboration)
- National University of Ireland, Galway (Collaboration)
- University of Bristol, United Kingdom (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- London Sch of Hygiene and Trop Medicine, United Kingdom (Collaboration)
- University Medical Centre Utrecht, Netherlands (Collaboration)
- University of Birmingham, United Kingdom (Collaboration)
- NAM: Aidsmap (Collaboration)
- Medicines and Healthcare Regulatory Agency (Collaboration)
- Dana-Farber Cancer Institute (Collaboration)
- Duke University, United States (Collaboration)
- University of Aberdeen, United Kingdom (Collaboration)
- University of Chicago, United States (Collaboration)
- The Global Health Network (Collaboration)
- NHS Health Research Authority (Collaboration)
- European Medicines Agency (Collaboration)
- King's College London, United Kingdom (Collaboration)
- NHS Digital (Collaboration)
- University of Southampton, United Kingdom (Collaboration)
- Public Health England, Salisbury (Collaboration)
- BioMarin Pharmaceutical (Collaboration)
- Alan Turing Institute (Collaboration)
- American Society of Clinical Oncology (ASCO) (Collaboration)
- Imperial Cancer Research Fund (Collaboration)
- Queen Mary, University of London, United Kingdom (Collaboration)
- Institute of Cancer Research UK (Collaboration)
- Society of Urologic Oncology (Collaboration)
- Novartis (Collaboration)
- F. Hoffmann-La Roche AG (Collaboration)
- Bayer (Collaboration)
- Brown University, United States (Collaboration)
- University of Basel, Switzerland (Collaboration)
- Vectura Ltd (Collaboration)
- National Institute for Health Research, United Kingdom (Collaboration)
- Granada University (Collaboration)
- University of Warwick, United Kingdom (Collaboration)
- Biomedical Research Centre Network for Epidemiology and Public Health (Collaboration)
- American Society for Radiation Oncology American Society Radiation Oncology (Collaboration)
- Zoology Ecology and Plant Science (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- Trials Methodology Research Network (Collaboration)
- Queen's University of Belfast, United Kingdom (Collaboration)
- University of York, United Kingdom (Collaboration)
- Medical Research Council (Collaboration)
- University of Leeds, United Kingdom (Collaboration)
- UK Clinical Research Collaboration (Collaboration)
- Radboud University Nijmegen, Netherlands (Collaboration)
- NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (Collaboration)
- Health Data Research Uk, London (Collaboration)
- University of Manchester, Manchester, United Kingdom (Collaboration)
Publications
Adshead F
(2021)
A strategy to reduce the carbon footprint of clinical trials
in The Lancet
Bass EJ
(2021)
PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.
in Contemporary clinical trials
Blagden SP
(2020)
Effective delivery of Complex Innovative Design (CID) cancer trials-A consensus statement.
in British journal of cancer
Brown LC
(2022)
Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer.
in Clinical trials (London, England)
Brueton V
(2017)
Best practice guidance for the use of strategies to improve retention in randomized trials developed from two consensus workshops.
in Journal of clinical epidemiology
Bruhn H
(2021)
Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.
in Trials
Choodari-Oskooei Babak
(2016)
Quantifying the uptake of user-written commands over time
in STATA JOURNAL
Clayton GL
(2017)
The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.
in Trials
| 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 |