Trials Methodology Research Partnership
Lead Research Organisation:
University of Liverpool
Department Name: Biostatistics
Abstract
Clinical trials are vital for testing whether a new treatment provides benefit to patients. There are tens of thousands of new clinical trials started each year, funded by both public and private sector. Trials are very expensive, both in terms of money but also burden on patient and healthcare systems. It is therefore important that clinical trials are done as efficiently as possible.
In the UK and Ireland there are several different groups of researchers who work on clinical trials. These groups have substantial expertise in particular areas of how to do more efficient and informative trials. This grant has the objective of bringing these researchers together as the Trials Methodology Research Partnership. This new partnership will focus on major areas where clinical trials need to be improved to help increase the health of society.
The partnership will consist of an executive committee that will oversee eight working groups. These groups will each tackle a major area for improving trials. Each working group will consist of experts across the UK who will identify what new work is needed in the area, and how to ensure the best methods can be used in real clinical trials. The working groups will put together new funding proposals for focused projects.
The groups making up the partnership have each committed funding for a research student who will work on a PhD in clinical trials methodology. These students will contribute towards the goals of the partnership.
This grant will provide funding to establish and coordinate the partnership and its working groups. It will also provide funding for three smaller research projects, which are linked with major priorities of the partnership.
The first focus is stratified medicine. This is about improving knowledge about which patients a new treatment works well for, allowing them to receive the best treatment for them. The typical way of doing clinical trials may not be suitable when a treatment works differently in different types of patient. A pilot project to be funded by this partnership will review what future trials research is needed to help stratify patients better. This pilot project will lead to a larger project for which a separate grant application will be made.
The second focus is health informatics. This is the use of new digital technology to improve trials. Health informatics has a huge potential to reduce the cost of and increase the amount of information available from trials. Linked with the first focus, more high-quality information may lead to better stratification of patients. The Health Informatics working group will hold a workshop to bring together expertise in this area. This will lead to identification of methodological issues that can be tested within future trials that make use of digital technology.
The third focus is global health trials. Many diseases are becoming more frequent in Low and Medium Income Countries (LMICs). Clinical trials conducted solely in LMICs are common but are often difficult to do. The global health working group will develop research projects to address these difficulties. It will help deliver this by making small grants available to encourage international cooperation between LMIC researchers and those based in UK and Ireland.
The partnership will also help support successful initiatives that have benefited UK trials methodology research such as the COMET Initiative, the International Clinical Trials Methodology Conference and the online guidance packs for best trial practice.
The partnership will support the development of further specific project grants. This will develop a new sustainable portfolio of trials research that will ensure the UK and Ireland is at the forefront of trials methodology research. The resulting research will make trials more efficient and improve healthcare worldwide.
In the UK and Ireland there are several different groups of researchers who work on clinical trials. These groups have substantial expertise in particular areas of how to do more efficient and informative trials. This grant has the objective of bringing these researchers together as the Trials Methodology Research Partnership. This new partnership will focus on major areas where clinical trials need to be improved to help increase the health of society.
The partnership will consist of an executive committee that will oversee eight working groups. These groups will each tackle a major area for improving trials. Each working group will consist of experts across the UK who will identify what new work is needed in the area, and how to ensure the best methods can be used in real clinical trials. The working groups will put together new funding proposals for focused projects.
The groups making up the partnership have each committed funding for a research student who will work on a PhD in clinical trials methodology. These students will contribute towards the goals of the partnership.
This grant will provide funding to establish and coordinate the partnership and its working groups. It will also provide funding for three smaller research projects, which are linked with major priorities of the partnership.
The first focus is stratified medicine. This is about improving knowledge about which patients a new treatment works well for, allowing them to receive the best treatment for them. The typical way of doing clinical trials may not be suitable when a treatment works differently in different types of patient. A pilot project to be funded by this partnership will review what future trials research is needed to help stratify patients better. This pilot project will lead to a larger project for which a separate grant application will be made.
The second focus is health informatics. This is the use of new digital technology to improve trials. Health informatics has a huge potential to reduce the cost of and increase the amount of information available from trials. Linked with the first focus, more high-quality information may lead to better stratification of patients. The Health Informatics working group will hold a workshop to bring together expertise in this area. This will lead to identification of methodological issues that can be tested within future trials that make use of digital technology.
The third focus is global health trials. Many diseases are becoming more frequent in Low and Medium Income Countries (LMICs). Clinical trials conducted solely in LMICs are common but are often difficult to do. The global health working group will develop research projects to address these difficulties. It will help deliver this by making small grants available to encourage international cooperation between LMIC researchers and those based in UK and Ireland.
The partnership will also help support successful initiatives that have benefited UK trials methodology research such as the COMET Initiative, the International Clinical Trials Methodology Conference and the online guidance packs for best trial practice.
The partnership will support the development of further specific project grants. This will develop a new sustainable portfolio of trials research that will ensure the UK and Ireland is at the forefront of trials methodology research. The resulting research will make trials more efficient and improve healthcare worldwide.
Technical Summary
Clinical trials provide the highest quality of information about new health interventions. They require large financial, patient and healthcare system resources to be successful. It is a priority for medical research that methodology for increasing the efficiency of clinical trials is developed.
In this Trials Methodology Research Partnership we propose to bring together several networks and institutions that have strong expertise in particular areas of trials research. The partnership will consist of an executive committee that will oversee eight working groups, each working in a distinct priority area for trials. Funding will be used to coordinate the partnership and its working groups. The partnership will also provide funding for several smaller research projects, which are linked with three priority areas for future trials research: stratified medicine, health informatics and global health.
The initial projects are: 1) a review of methodology gaps for which future trials research is needed to help stratify patients better; 2) collation of ongoing studies followed by a workshop to bring together expertise in health informatics; a prioritization exercise to design Studies Within A Trial (SWATs) that could be embedded within future trials to build an evidence base for best use of digital technology in trials; 3) a pump-priming funding stream to enable international collaboration between researchers from resource-poor countries and those based in UK and Ireland, to encourage methodology research for global health trials.
The partnership will also create a national cohort of PhD students who will work on clinical trials methodology, and continue support for successful initiatives such as the International Clinical Trials Methodology Conference and online guidance packs for best trial practice.
The initial investment in this Partnership will lead to future proposals for larger, focused research projects that will make future trials more efficient.
In this Trials Methodology Research Partnership we propose to bring together several networks and institutions that have strong expertise in particular areas of trials research. The partnership will consist of an executive committee that will oversee eight working groups, each working in a distinct priority area for trials. Funding will be used to coordinate the partnership and its working groups. The partnership will also provide funding for several smaller research projects, which are linked with three priority areas for future trials research: stratified medicine, health informatics and global health.
The initial projects are: 1) a review of methodology gaps for which future trials research is needed to help stratify patients better; 2) collation of ongoing studies followed by a workshop to bring together expertise in health informatics; a prioritization exercise to design Studies Within A Trial (SWATs) that could be embedded within future trials to build an evidence base for best use of digital technology in trials; 3) a pump-priming funding stream to enable international collaboration between researchers from resource-poor countries and those based in UK and Ireland, to encourage methodology research for global health trials.
The partnership will also create a national cohort of PhD students who will work on clinical trials methodology, and continue support for successful initiatives such as the International Clinical Trials Methodology Conference and online guidance packs for best trial practice.
The initial investment in this Partnership will lead to future proposals for larger, focused research projects that will make future trials more efficient.
Planned Impact
Who will benefit from this research?
The cross-disciplinary nature of the Partnership's research portfolio and networks will ensure that a wide range of users will benefit from this research, including clinical trial practitioners, systematic reviewers, patients and the public, regulators, research funders, journal editors, policymakers, and methodologists.
How will they benefit from this research?
The Trials Methodology Research Partnership (TMRP) will facilitate the advancement of clinical trials methodology which will lead to improvements in, and increased efficiency of, clinical trials, leading to improvements in health care. Direct and indirect impacts for users include:
(1) Clinical trial practitioners: Our research will generate new knowledge and innovative methodologies which will be deliberately developed to be of relevance to clinical trial practitioners who will also benefit from our related training activities. Through our PhD student cohort, the TMRP will deliver highly skilled researchers in priority areas such as health informatics, medical statistics and health economics, who will directly benefit clinical trial practitioners through the TMRP advisory service, and by developing this workforce for future clinical trials. This area of activity will be facilitated and enhanced by our TMRP Clinical Engagement Lead.
(2) Systematic reviewers: The TMRP research and training programme that focusses on improving the conduct, analysis and reporting of clinical trials has the potential to directly improve the systematic review process (e.g. disseminating recommendations on outcome reporting to clinical trialists will reduce the important problem of outcome reporting bias in systematic reviews). Our research will also contribute to recommendations about how best to use systematic reviews to inform clinical trial design and conduct through, for example, opportunities afforded by HRB TMRN's recent award for capacity development in evidence synthesis.
(3) Patients and the public: We aim to generate research that will directly impact upon participants of clinical trials, as well as the wider patient groups for which those trial results apply. Use of innovative, more appropriate, evidence-based methods in clinical trials will lead to trial results that are more applicable (e.g. using outcomes that are relevant to patients), which will improve clinical decisions and impact on patients' quality of life, health and well-being.
(4) Research Funders: MRC- and HRB-funded partners have already achieved some impact with trial funders. TMRP will allow shared knowledge of what works in stakeholder engagement to achieve direct impact. TMRP will engage with the international effort to improve efficiency of clinical trials and reducing 'research waste', targeting global funders with NIHR's help.
(5) Journal editors: Activities within TMRP that focus on research to improve the reporting of clinical trials will be of direct benefit to journal editors. Partners are involved with international groups such as the EQUATOR Network and CONSORT, and these links will be exploited to aid dissemination.
(6) Policymakers: Through COMET we are learning how to engage with influential policymakers such as PCORI (USA), NICE (UK), and the Guidelines International Network.
(7) Methodologists: We will develop and apply new and innovative clinical trial methodologies which will directly benefit other clinical trial methodology researchers and aid future advancement of methodological research. Our training courses will allow methodologists to gain knowledge in cross-disciplinary clinical trials research methods.
(8) Regulators: Strategic connections with the regulatory authorities will be developed as appropriate to an initiative or project. Examples to date are the work with the FDA through the Clinical Trials Transformation Initiative, MHRA in the development of a risk-based monitoring tool, and EMA regarding core outcome sets.
The cross-disciplinary nature of the Partnership's research portfolio and networks will ensure that a wide range of users will benefit from this research, including clinical trial practitioners, systematic reviewers, patients and the public, regulators, research funders, journal editors, policymakers, and methodologists.
How will they benefit from this research?
The Trials Methodology Research Partnership (TMRP) will facilitate the advancement of clinical trials methodology which will lead to improvements in, and increased efficiency of, clinical trials, leading to improvements in health care. Direct and indirect impacts for users include:
(1) Clinical trial practitioners: Our research will generate new knowledge and innovative methodologies which will be deliberately developed to be of relevance to clinical trial practitioners who will also benefit from our related training activities. Through our PhD student cohort, the TMRP will deliver highly skilled researchers in priority areas such as health informatics, medical statistics and health economics, who will directly benefit clinical trial practitioners through the TMRP advisory service, and by developing this workforce for future clinical trials. This area of activity will be facilitated and enhanced by our TMRP Clinical Engagement Lead.
(2) Systematic reviewers: The TMRP research and training programme that focusses on improving the conduct, analysis and reporting of clinical trials has the potential to directly improve the systematic review process (e.g. disseminating recommendations on outcome reporting to clinical trialists will reduce the important problem of outcome reporting bias in systematic reviews). Our research will also contribute to recommendations about how best to use systematic reviews to inform clinical trial design and conduct through, for example, opportunities afforded by HRB TMRN's recent award for capacity development in evidence synthesis.
(3) Patients and the public: We aim to generate research that will directly impact upon participants of clinical trials, as well as the wider patient groups for which those trial results apply. Use of innovative, more appropriate, evidence-based methods in clinical trials will lead to trial results that are more applicable (e.g. using outcomes that are relevant to patients), which will improve clinical decisions and impact on patients' quality of life, health and well-being.
(4) Research Funders: MRC- and HRB-funded partners have already achieved some impact with trial funders. TMRP will allow shared knowledge of what works in stakeholder engagement to achieve direct impact. TMRP will engage with the international effort to improve efficiency of clinical trials and reducing 'research waste', targeting global funders with NIHR's help.
(5) Journal editors: Activities within TMRP that focus on research to improve the reporting of clinical trials will be of direct benefit to journal editors. Partners are involved with international groups such as the EQUATOR Network and CONSORT, and these links will be exploited to aid dissemination.
(6) Policymakers: Through COMET we are learning how to engage with influential policymakers such as PCORI (USA), NICE (UK), and the Guidelines International Network.
(7) Methodologists: We will develop and apply new and innovative clinical trial methodologies which will directly benefit other clinical trial methodology researchers and aid future advancement of methodological research. Our training courses will allow methodologists to gain knowledge in cross-disciplinary clinical trials research methods.
(8) Regulators: Strategic connections with the regulatory authorities will be developed as appropriate to an initiative or project. Examples to date are the work with the FDA through the Clinical Trials Transformation Initiative, MHRA in the development of a risk-based monitoring tool, and EMA regarding core outcome sets.
Organisations
- University of Liverpool (Lead Research Organisation, Project Partner)
- Public Health Agency (Co-funder)
- Chief Scientist Office (Co-funder)
- Welsh Government (Co-funder)
- Liverpool School of Tropical Medicine (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- University of Sheffield (Collaboration)
- King Edward Memorial Hospital Research Centre (Collaboration)
- Medical Research Council (MRC) (Collaboration)
- Lancaster University (Collaboration)
- Newcastle University (Collaboration, Project Partner)
- UKCRC Registered trials CTU network (Collaboration)
- UNIVERSITY OF CAMBRIDGE (Collaboration)
- UNIVERSITY OF OXFORD (Collaboration)
- Bayer (Collaboration)
- Institute of Cancer Research UK (Collaboration)
- KING'S COLLEGE LONDON (Collaboration)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- Eisai Ltd (Collaboration)
- Makerere University College of Health Sciences (Collaboration)
- Soroti University (Collaboration)
- AstraZeneca (Collaboration)
- Kenyan Institute for Medical Research (KEMRI) (Collaboration)
- Amgen Inc (Collaboration)
- Janssen Pharmaceutica NV (Collaboration)
- UNIVERSITY OF ABERDEEN (Collaboration)
- Cardiff University (Collaboration)
- The Global Health Network (Collaboration)
- Roche Pharmaceuticals (Collaboration)
- UNIVERSITY OF LEEDS (Collaboration)
- UNIVERSITY OF LIVERPOOL (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- University of Cape Town (Collaboration)
- University of Bristol (Collaboration)
- University College London (Collaboration)
- Trials Methodology Research Network (Collaboration)
- UK Trial Managers Network (Collaboration)
- BANGOR UNIVERSITY (Collaboration)
- HEALTH DATA RESEARCH UK (Collaboration)
- University of Aberdeen (Project Partner)
- Institute of Cancer Research (Project Partner)
- Bangor University (Project Partner)
- Liverpool School of Tropical Medicine (Project Partner)
- University College London (Project Partner)
- University of Birmingham (Project Partner)
- Queen Mary University of London (Project Partner)
- CARDIFF UNIVERSITY (Project Partner)
- UNIVERSITY OF EXETER (Project Partner)
- University of Nottingham (Project Partner)
- Plymouth University (Project Partner)
- National University of Ireland, Galway (Project Partner)
- Lancaster University (Project Partner)
- University of Leeds (Project Partner)
- University of York (Project Partner)
- University of Manchester (Project Partner)
- University of Sheffield (Project Partner)
- University of Oxford (Project Partner)
- University of Cambridge (Project Partner)
- University of Warwick (Project Partner)
- University of Edinburgh (Project Partner)
- University of East Anglia (Project Partner)
- King's College London (Project Partner)
Publications
Adshead F
(2021)
A strategy to reduce the carbon footprint of clinical trials.
in Lancet (London, England)
Alshreef A
(2019)
Statistical Methods for Adjusting Estimates of Treatment Effectiveness for Patient Nonadherence in the Context of Time-to-Event Outcomes and Health Technology Assessment: A Systematic Review of Methodological Papers.
in Medical decision making : an international journal of the Society for Medical Decision Making
Barrington H
(2021)
Patient participation in Delphi surveys to develop core outcome sets: systematic review.
in BMJ open
Beecher C
(2023)
Irish funder guidance increased searching for, and uptake of, core outcome sets
in Journal of Clinical Epidemiology
Boxall C
(2022)
Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
in Research Methods in Medicine & Health Sciences
Butcher NJ
(2022)
Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.
in JAMA
Butcher NJ
(2022)
Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.
in JAMA
Cherlin S
(2024)
Cross-validated risk scores adaptive enrichment (CADEN) design.
in Contemporary clinical trials
Cherlin S
(2023)
Utilising high-dimensional data in randomised clinical trials: A review of methods and practice
in Research Methods in Medicine & Health Sciences
| Description | Citation in EUNeHTA guidance on use of surrogates |
| Geographic Reach | Europe |
| Policy Influence Type | Citation in other policy documents |
| Impact | Impact on EU HTA agency policy n handling of surrogate outcomes in new technology assessments. |
| URL | https://www.eunethta.eu/methodological-guideline-for-rea-of-pharmaceuticals-surrogate-endpoints/ |
| Description | Citation in NICE TA Guidelines |
| Geographic Reach | Europe |
| Policy Influence Type | Citation in other policy documents |
| Impact | Impacted on NICE methods policy around coverage of new health technologies based on surrogate evidence. |
| URL | https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guid... |
| Description | Contributions to, and recommendations captured in Goldacre Report (2022) |
| Geographic Reach | National |
| Policy Influence Type | Contribution to a national consultation/review |
| URL | https://www.gov.uk/government/publications/better-broader-safer-using-health-data-for-research-and-a... |
| Description | £100,000 HDR UK Discretionary Fund 2022-2023 |
| Amount | £100,000 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 03/2022 |
| End | 03/2023 |
| Description | ACCESS: A collaborative study to identify the activities needed to improve representation of under-served groups in trials and understand their implementation |
| Amount | £79,500 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 09/2022 |
| Description | Costing Adaptive Trials (CAT): developing best practice for CTUs supporting adaptive trials |
| Amount | £55,629 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2019 |
| End | 10/2021 |
| Description | Doctoral Training Programme |
| Amount | £2,518,806 (GBP) |
| Funding ID | MR/W006049/1 |
| Organisation | MRC Doctoral Training Program |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | 08/2022 |
| End | 08/2028 |
| Description | Enabling lower carbon clinical trials: Development and prototype testing of a method to quantify the carbon footprint of current clinical trials to inform future lower carbon clinical trial design. |
| Amount | £76,284 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 10/2022 |
| Description | Exploring the construction, reporting and interpretation of composite outcomes in randomised trials of invasive procedures. |
| Amount | £29,488 (GBP) |
| Organisation | Academy of Medical Sciences (AMS) |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 03/2022 |
| End | 04/2024 |
| Description | HDR UK Discretionary Fund 2022-2023 PRIMORANT study |
| Amount | £100,000 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 07/2022 |
| End | 03/2023 |
| Description | HEIF Impact Case Study Specialist Support Fund |
| Amount | £8,100 (GBP) |
| Organisation | Higher Education Innovation Funding (HEIF) |
| Sector | Public |
| Country | United Kingdom |
| Start | 11/2019 |
| End | 07/2020 |
| Description | HRB-TMRN Working Group Funding Call 2020 Dr Catherine Houghton PI TCWG |
| Amount | € 9,515 (EUR) |
| Organisation | Trials Methodology Research Network |
| Sector | Private |
| Country | Ireland |
| Start | |
| Description | HRB-TMRN Working Group Funding Call 2020 Dr Frances Shiely PI TCWG |
| Amount | € 9,997 (EUR) |
| Organisation | Trials Methodology Research Network |
| Sector | Private |
| Country | Ireland |
| Start | |
| Description | HRB-TMRN Working Group Funding Call 2020 Prof Patricia Kearney PI HIWG |
| Amount | € 9,889 (EUR) |
| Organisation | Trials Methodology Research Network |
| Sector | Private |
| Country | Ireland |
| Start | |
| Description | Improving ethnic diversity in trials: helping trial teams recruit and retain the ethnic groups essential for results with community-wide relevance and applicability. |
| Amount | £188,146 (GBP) |
| Funding ID | HIPS/21/02 |
| Organisation | Chief Scientist Office |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 04/2023 |
| Description | MRC ISPF funding for TMRP activity in ODA countries |
| Amount | £37,487 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2023 |
| End | 03/2024 |
| Description | MRFF - Research Grants |
| Amount | $999,286 (AUD) |
| Funding ID | MRF2007650 |
| Organisation | National Health and Medical Research Council |
| Sector | Public |
| Country | Australia |
| Start | 01/2022 |
| End | 01/2024 |
| Description | NIHR HTA 2023-2025: PR Williamson (co-PI), L Fox (co-PI). Low carbon clinical trials |
| Amount | £200,000 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2023 |
| End | 01/2025 |
| Description | NIHR RSS 2023-2028 |
| Amount | £2,268,944 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2023 |
| End | 09/2028 |
| Description | Reporting of randomised trials using surrogate outcomes: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statements |
| Amount | £100,000 (GBP) |
| Funding ID | MR/V038400/1 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 07/2023 |
| Description | Transforming treatment of immune-mediated inflammatory diseases through better trials and evaluations |
| Amount | £1,563,340 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 12/2021 |
| End | 11/2026 |
| Description | Trial Forge Guidance 3: Ethical issues in SWATs (Studies within a Trial) |
| Amount | € 10,000 (EUR) |
| Organisation | Health Research Board (HRB) |
| Sector | Public |
| Country | Ireland |
| Start | 01/2022 |
| End | 10/2022 |
| Description | Trials Methodology Research Partnership (TMRP) Doctoral Training Partnership (DTP) |
| Amount | £2,518,806 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 10/2028 |
| Description | Using behavioural science to enhance uptake of Core Outcome Sets in trials |
| Amount | € 9,224 (EUR) |
| Organisation | Health Research Board (HRB) |
| Sector | Public |
| Country | Ireland |
| Start | 01/2022 |
| End | 10/2022 |
| Title | NIHR INCLUDE Impaired Capacity to Consent Framework |
| Description | The NIHR INCLUDE Impaired Capacity to Consent Framework is a tool for researchers to ensure that their trial is designed to be inclusive of people with impaired capacity to consent, as well as improving the quality of the trial design and funding application. It should preferably be used at the earliest stage when designing a trial (for example, it might be used when developing an NIHR Stage 2 application), however it can also inform later stages of developing the trial such as when drafting the protocol and ethics application. The framework is intended to be used with all populations who may experience impaired capacity, although the issues raised will differ between populations and trial contexts. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2024 |
| Provided To Others? | Yes |
| Impact | tbc |
| Title | Protocol for a methods systematic review |
| Description | Isaacs T, Vaughan A, Shiely F, Finucane E, Gillies K, Noor N, et al. Systematic review of the prevalence and assessment of language-related eligibility criteria in patient recruitment to type 2 diabetes and depression trials. . PROSPERO: International prospective register of systematic reviews. 2021;(CRD42021267905 |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not as yet |
| Title | Standard Operating Procedure |
| Description | A Standard Operating Procedure for sharing clinical trial participant data. Tudur Smith C, Booth G, Fenton K, Gamble C, Hepburn J, Howe N, et al. Considerations for a Participant Data Sharing SOP. UKCRC website: 2021 Contract No.: 2021-10-06. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | The UKCRC Clinical Trials Unit Network are implementing this SOP. |
| Title | TMRN-TMRP Communication Wheel for Enhanced Stakeholder Engagement |
| Description | The TMRN-TMRP Communication Wheel is a visual aid identifying key groups of stakeholders and when to engage with each during trial development, conduct, and dissemination of results. The TMRN-TMRP Communication Wheel aims to promote systematic communication plans that effectively engage diverse stakeholders at different trial stages according to their distinct needs. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2024 |
| Provided To Others? | Yes |
| Impact | Recent resource - An evaluation process will refine the wheel following its launch. |
| URL | https://www.hrb-tmrn.ie/2024/02/01/tmrn_tmrp_comms-wheel/ |
| Title | Supplemental Material - Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials |
| Description | Supplemental Material for Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials by Cherish Boxall, Shaun Treweek, Katie Gillies; on behalf of the Trials Methodology Research Partnership Trial Conduct Working Group in Research Methods in Medicine & Health Sciences |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| URL | https://sage.figshare.com/articles/dataset/Supplemental_Material_-_Studies_within_a_trial_priorities... |
| Title | Supplemental Material - Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials |
| Description | Supplemental Material for Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials by Cherish Boxall, Shaun Treweek, Katie Gillies; on behalf of the Trials Methodology Research Partnership Trial Conduct Working Group in Research Methods in Medicine & Health Sciences |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| URL | https://sage.figshare.com/articles/dataset/Supplemental_Material_-_Studies_within_a_trial_priorities... |
| Title | Supplemental Material - Utilising high-dimensional data in randomised clinical trials: A review of methods and practice |
| Description | Supplemental Material for Utilising high-dimensional data in randomised clinical trials: A review of methods and practice by Svetlana Cherlin, Theophile Bigirumurame, Michael J Grayling, Jérémie Nsengimana, Luke Ouma, Aida Santaolalla, Fang Wan, S Faye Williamson and James MS Wason in Research Methods in Medicine & Health Sciences. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2023 |
| Provided To Others? | Yes |
| URL | https://sage.figshare.com/articles/dataset/Supplemental_Material_-_Utilising_high-dimensional_data_i... |
| Title | Supplemental Material - Utilising high-dimensional data in randomised clinical trials: A review of methods and practice |
| Description | Supplemental Material for Utilising high-dimensional data in randomised clinical trials: A review of methods and practice by Svetlana Cherlin, Theophile Bigirumurame, Michael J Grayling, Jérémie Nsengimana, Luke Ouma, Aida Santaolalla, Fang Wan, S Faye Williamson and James MS Wason in Research Methods in Medicine & Health Sciences. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2023 |
| Provided To Others? | Yes |
| URL | https://sage.figshare.com/articles/dataset/Supplemental_Material_-_Utilising_high-dimensional_data_i... |
| Description | Adaptive Designs TMRP working group |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | NA |
| Collaborator Contribution | The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge). |
| Impact | tbc |
| Start Year | 2019 |
| Description | Adaptive Designs TMRP working group |
| Organisation | University of Cambridge |
| Department | MRC Biostatistics Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | NA |
| Collaborator Contribution | The Adaptive Designs TMRP WG succeeds the HTMR Network Adaptive designs working group and is co-led by Thomas Jaki (Lancaster) and Sofia Villar (Cambridge). |
| Impact | tbc |
| Start Year | 2019 |
| Description | Assessment of the challenges encountered in implementing vaccine clinical trial methodologies in low income countries GH/146 |
| Organisation | Muhimbili University of Health and Allied Sciences |
| Country | Tanzania, United Republic of |
| Sector | Academic/University |
| PI Contribution | TMRP provided funding for this project |
| Collaborator Contribution | Effective vaccine use is a global approach expected to eliminate infectious diseases. Recent developments have been made to produce a number of vaccines which are in various phases of clinical trial such as Tuberculosis (TB), malaria and human immunodeficiency virus (HIV) vaccines. Despite of these, only few vaccine clinical trials are conducted in low and middle income countries including sub-Saharan Africa. An exploratory qualitative study is ongoing in Tanzania to explore the challenges encountered by vaccine trial investigators when implementing vaccine trial methodologies. The key informant interview that involves, trial coordinators, principal investigators, pharmacists, nurses and laboratory scientists is being conducted to explore their experiences on the conduct of vaccine trials in low middle income countries like Tanzania. Also, key informants from clinical trial regulators and ethical committees are involved. Similarly, trial participants are involved in the focus group discussion to explore the challenges they encounter for their involvement in vaccine clinical trial. Currently, the key informants from TB and HIV vaccine trial and clinical trial regulators have been interviewed. Recruitment of key informants from malaria vaccine trial and ethical committee is still ongoing. |
| Impact | No outputs yet - ongoing project |
| Start Year | 2020 |
| Description | Cultural competence in trial design and conduct GH/132 |
| Organisation | Medical Research Council of South Africa (MRC) |
| Department | Alcohol, Tobacco and Other Drugs Research Unit |
| Country | South Africa |
| Sector | Public |
| PI Contribution | TMRP provided the funding for this project |
| Collaborator Contribution | The Project aims to evaluate the applicability and utility of currently available tools to measure cultural competence in trial design and conduct. Cultural competency refers to consideration of the cultural and linguistic diversity of the populations targeted for inclusion into a trial. Failure to consider relevant cultural and diversity parameters during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, adherence, and retention, potentially reducing overall internal validity. We will retrospectively apply the 2007 Gibbs framework and the GRIPP-2 checklist to Project Mind, a three-arm cluster randomised controlled trial of 1,340 patients conducted in 24 primary care clinics in both urban and rural settings in South Africa. Project Mind compares two different systems approaches to integrating mental health counselling into chronic disease care with treatment as usual. To date, we have completed secondary data source identification and collation, pilot tested the Gibbs framework on trial documentation, presented the methods in a journal club and received feedback, and created an interactive trial timeline. |
| Impact | No outputs yet - ongoing project |
| Start Year | 2020 |
| Description | EXPLORING BARRIERS TO DATA REUSE GH/167 |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | TMRP provided the funding for this project |
| Collaborator Contribution | Despite the effort and investment to promote data sharing in the last decade, secondary data users still cite lack of access to quality and relevant data as a challenge. Ironically, repositories report low usage of clinical research datasets. This study aims to establish if and how clinical research datasets existing in the public domain are accessed and used and to describe barriers and opportunities to promote use of shared data from the perspective of secondary data users. With a focus on respondents from Low and Middle Income Countries (LMICs), we will conduct an online survey among clinical researchers and in-depth interviews with individuals who use clinical research datasets. Results from this work will be valuable in identifying which interventions should be prioritised to increase utilization of shared datasets in LMICs. We anticipate that increased reuse of data will result in improved quality and transparency in science, improved public health and patient outcomes, and better return on investment in research. The study is now approved by the Oxford Tropical Research Ethics Committee. Data collection will begin in February 2021. |
| Impact | No outputs yet - project ongoing |
| Start Year | 2020 |
| Description | Global Health TMRP Working Group |
| Organisation | Liverpool School of Tropical Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Global Health TMRP WG is a new working group set up from 2019 as part of TMRP, it is co-lead by Elizabeth Allen (Cape Town, SA) and Duolau Wang (LSTM) |
| Impact | tbc The TMRP Global Health Pump Priming funding call was opened early 2020. |
| Start Year | 2019 |
| Description | Global Health TMRP Working Group |
| Organisation | University of Cape Town |
| Country | South Africa |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Global Health TMRP WG is a new working group set up from 2019 as part of TMRP, it is co-lead by Elizabeth Allen (Cape Town, SA) and Duolau Wang (LSTM) |
| Impact | tbc The TMRP Global Health Pump Priming funding call was opened early 2020. |
| Start Year | 2019 |
| Description | Health Economics TMRP working group |
| Organisation | Bangor University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Health Economics TMRP working group is a continuation of the HTMR Network working group with refreshed membership and objectives - co-lead by Dyfrig Hughes (Bangor) and Sarah Wordsworth (Oxford) |
| Impact | tbc |
| Start Year | 2019 |
| Description | Health Economics TMRP working group |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Health Economics TMRP working group is a continuation of the HTMR Network working group with refreshed membership and objectives - co-lead by Dyfrig Hughes (Bangor) and Sarah Wordsworth (Oxford) |
| Impact | tbc |
| Start Year | 2019 |
| Description | Health Informatics TMRP working group |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | na |
| Collaborator Contribution | The Health Informatics TMRP working group is a new working group for the TMRP Partnership from 2019 co-led by Matt Sydes (MRC CTU at UCL) and Amanda Farrin (University of Leeds) with new objectives and newly recruited membership |
| Impact | tba |
| Start Year | 2019 |
| Description | Health Informatics TMRP working group |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Health Informatics TMRP working group is a new working group for the TMRP Partnership from 2019 co-led by Matt Sydes (MRC CTU at UCL) and Amanda Farrin (University of Leeds) with new objectives and newly recruited membership |
| Impact | tba |
| Start Year | 2019 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Amgen Inc |
| Country | United States |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Bayer |
| Country | Germany |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Eisai Ltd |
| Country | Japan |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Janssen Pharmaceutica NV |
| Country | Belgium |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Roche Pharmaceuticals |
| Country | Global |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contributions to discussions and plans. Bringing academic perspective. |
| Impact | Outputs to follow |
| Start Year | 2021 |
| Description | Optimising Informed CONsent in clinical trials in low- and middle-income settings: feasibility of an adapted QuinteT Recruitment Intervention (QRI) in India (OrION-I) GH/264 |
| Organisation | King Edward Memorial Hospital Research Centre |
| Country | India |
| Sector | Hospitals |
| PI Contribution | TMRP provided funding for this project |
| Collaborator Contribution | The OrION-I (Optimising Informed CONsent in clinical trials in India) study is a collaborative project between King Edward Memorial Hospital (KEMH), Mumbai, India and the University of Bristol (UoB), UK. The study at KEMH-Mumbai aims to investigate the feasibility and acceptability of audio-recording clinical trial discussions with patients, analysing them qualitatively and using them to provide feedback to recruiters to optimise informed consent. Methods employed will involve audio-recording trial consultations, interviewing patients and recruiters to elicit their perceptions regarding the audio-recording and feedback processes, and developing data management/sharing mechanisms for a large-scale study. The methods draw from the QuinteT Recruitment Intervention (QRI), developed at UoB with support from MRC-HTMR and applied in nearly 70 trials in the UK, to optimise recruitment while safeguarding informed consent. OrION-I study team's longer-term vision is that the research at KEMH-Mumbai, which is a large, research-active, tertiary referral centre in India, will facilitate the development of a collaborative grant aimed at optimising informed consent in clinical trials across other centres in India. Despite some early delays due to the pandemic, we have been able to make considerable progress in obtaining approvals, and are now at the stage of final approval required to start data collection. |
| Impact | No outputs yet - project ongoing |
| Start Year | 2020 |
| Description | Optimising Informed CONsent in clinical trials in low- and middle-income settings: feasibility of an adapted QuinteT Recruitment Intervention (QRI) in India (OrION-I) GH/264 |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | TMRP provided funding for this project |
| Collaborator Contribution | The OrION-I (Optimising Informed CONsent in clinical trials in India) study is a collaborative project between King Edward Memorial Hospital (KEMH), Mumbai, India and the University of Bristol (UoB), UK. The study at KEMH-Mumbai aims to investigate the feasibility and acceptability of audio-recording clinical trial discussions with patients, analysing them qualitatively and using them to provide feedback to recruiters to optimise informed consent. Methods employed will involve audio-recording trial consultations, interviewing patients and recruiters to elicit their perceptions regarding the audio-recording and feedback processes, and developing data management/sharing mechanisms for a large-scale study. The methods draw from the QuinteT Recruitment Intervention (QRI), developed at UoB with support from MRC-HTMR and applied in nearly 70 trials in the UK, to optimise recruitment while safeguarding informed consent. OrION-I study team's longer-term vision is that the research at KEMH-Mumbai, which is a large, research-active, tertiary referral centre in India, will facilitate the development of a collaborative grant aimed at optimising informed consent in clinical trials across other centres in India. Despite some early delays due to the pandemic, we have been able to make considerable progress in obtaining approvals, and are now at the stage of final approval required to start data collection. |
| Impact | No outputs yet - project ongoing |
| Start Year | 2020 |
| Description | Outcomes TMRP Working group |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Outcomes TMRP working group is a continuation of the HTMR Network working group with refreshed membership and objectives - co-lead by Kerry Avery (Bristol) and Chris Weir (Edinburgh). |
| Impact | tbc |
| Start Year | 2019 |
| Description | PANDA - A Practical Adaptive and Novel Designs and Analysis Toolkit |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Collaborator Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Impact | Outputs forthcoming. |
| Start Year | 2022 |
| Description | PANDA - A Practical Adaptive and Novel Designs and Analysis Toolkit |
| Organisation | Lancaster University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Collaborator Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Impact | Outputs forthcoming. |
| Start Year | 2022 |
| Description | PANDA - A Practical Adaptive and Novel Designs and Analysis Toolkit |
| Organisation | University College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Collaborator Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Impact | Outputs forthcoming. |
| Start Year | 2022 |
| Description | PANDA - A Practical Adaptive and Novel Designs and Analysis Toolkit |
| Organisation | University of Sheffield |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Collaborator Contribution | This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. |
| Impact | Outputs forthcoming. |
| Start Year | 2022 |
| Description | PRISMS Study GH/182 |
| Organisation | Kenyan Institute for Medical Research (KEMRI) |
| Department | Wellcome Trust Research Programme (KWTRP) |
| Country | Kenya |
| Sector | Academic/University |
| PI Contribution | TMRP provided the funding for this project |
| Collaborator Contribution | Failure to achieve valid randomisation and allocation concealment may result in biased estimates of treatment effects and potential loss of objectivity in clinical trials. The traditional use of envelopes is vulnerable to manipulation and the risk of damage to envelopes during shipping and at storage. Additionally, the filling and sealing envelopes is a tedious time-consuming process prone to error. Other randomization alternatives such as web-based methods are preferred. However, they are expensive and not suitable in low resource settings with poor internet infrastructure. Mobile-based text messaging offers a low-cost and reliable alternative. We propose to undertake a pilot comparative study of a short message service (SMS) randomization method versus sealed, opaque envelopes alongside an ongoing randomized controlled trial. The SMS platform will be developed in a 3-tier architecture that supports data storage, business logic processing and a presentation end. An evaluation will be conducted to determine random sequence accuracy, to document user experience, to measure response time and cost. A user framework will be developed to guide implementation at scale in future studies and to provide a reliable and low-cost alternative platform to support the increasing number of large and complex clinical trials in low-resource settings. |
| Impact | No outputs yet - ongoing project. |
| Start Year | 2020 |
| Description | Photovoice to explore community members perspectives regarding health and healthcare challenges in Mukono District, Uganda GH/105 |
| Organisation | Makerere University College of Health Sciences |
| Country | Uganda |
| Sector | Academic/University |
| PI Contribution | TMRP provided the funding for this project |
| Collaborator Contribution | There have been calls for a greater number of clinical studies in low- and middle-income countries (LMICs) to explore locally identified areas of concern, in order to ensure research studies are contextually relevant. One useful approach to help achieve this aim is Community Based Participatory Research (CBPR), which broadly involves local stakeholders being central to the research process. CBPR is often guided by the hypothesis that such an approach can help to ensure research remains contextually relevant, and helps to better understand the lived experiences of a community. Specific to clinical trials, CBPR has consistently been suggested as a means of diversifying participation, as well as increasing relevance and quality to end users (i.e. patients or community members). One method aligned to the CBPR paradigm is photovoice. In a photovoice study, cameras are given to individuals in order to capture photographic images around a central theme which is normally of community importance or concern. In our project, the subject of interest is exploring concerns and challenges related to healthcare in the community. To date 15 community members from the Seeta Nazigo Parish, Mukono District located in central Uganda have been selected to participate in the photovoice project. Participants have been provided with initial training in the use of cameras and have undergone one full round of photographic capture and image discussion with the project team. |
| Impact | No outputs yet - ongoing project |
| Start Year | 2020 |
| Description | Statistical Analysis TMRP Working group |
| Organisation | King's College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Statistical Analysis TMRP working group is a new working group with newly recruited membership and objectives - co-lead by Richard Emsley (KCL) and Tim Morris (UCL) |
| Impact | tbc |
| Start Year | 2019 |
| Description | Statistical Analysis TMRP Working group |
| Organisation | University College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Statistical Analysis TMRP working group is a new working group with newly recruited membership and objectives - co-lead by Richard Emsley (KCL) and Tim Morris (UCL) |
| Impact | tbc |
| Start Year | 2019 |
| Description | Stratified medicine TMRP Working Group |
| Organisation | Institute of Cancer Research UK |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Stratified Medicine TMRP working group is a continuation of the HTMR Network stratified medicine working group with refreshed membership and objectives - co-led by James Wason (Newcastle/Cambridge) and Christina Yap (ICR). |
| Impact | na |
| Start Year | 2019 |
| Description | Stratified medicine TMRP Working Group |
| Organisation | Newcastle University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Stratified Medicine TMRP working group is a continuation of the HTMR Network stratified medicine working group with refreshed membership and objectives - co-led by James Wason (Newcastle/Cambridge) and Christina Yap (ICR). |
| Impact | na |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | The Global Health Network |
| Country | Global |
| Sector | Charity/Non Profit |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | Trials Methodology Research Network |
| Country | Ireland |
| Sector | Private |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | UK Trial Managers Network |
| Sector | Academic/University |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The MRC-NIHR Trials Methodology Research Partnership - Partners |
| Organisation | UKCRC Registered trials CTU network |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. The partnership is led by Paula Williamson (University of Liverpool), chair of HTMR Network. |
| Collaborator Contribution | The MRC-NIHR Trials Methodology Research Partnership was funded from June 2019 for 36months. The above six partners form the partnership and are represented as the Executive Committee. |
| Impact | TBC |
| Start Year | 2019 |
| Description | The practice of pilot studies in informing the conduct of HIV clinical trials in sub Saharan Africa: a review of study protocols GH/221 |
| Organisation | Soroti University |
| Country | Uganda |
| Sector | Academic/University |
| PI Contribution | TMRP provided the funding for this project |
| Collaborator Contribution | Introduction: Pilot/feasibility studies represent a fundamental phase of the research process and play a vital role in the preliminary planning of a full size clinical trial. Sub-Saharan Africa hosts the majority of HIV clinical trials in the world, however, it is not well documented how pilot/feasibility studies are utilised as a pre-requisite step for the conduct of larger HIV clinical trials in this region. Objective: The objective of our scoping review is to establish the extent to which larger HIV related clinical trials in sub-Saharan Africa are informed by a prior pilot/feasibility study. Methods: This is a scoping review that will follow the JBI methodology for scoping reviews. Six databases including MEDLINE (OVID), CINAHL, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL) databases, and African Index Medicus (AIM) were systematically searched to identify potential articles. Gray literature was also searched. Data was extracted and charted using a structured tool adapted from the JBI scoping review methodology guideline. Data will be analysed and interpreted using simple descriptive statistics while patterns and trends (if identified) will be illustrated using figures and/or diagrams, and summarized in a narrative. Final conclusions will be drawn and recommendations for research and practice may be proposed. |
| Impact | No outputs yet - project ongoing |
| Start Year | 2020 |
| Description | Trial Conduct TMRP Working group |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Trial Conduct TMRP working group is a continuation of the HTMR Network Trial conduct working group with refreshed membership, objectives and leadership - co-led by katie Gillies (Aberdeen) and Kerry Hood (Cardiff). |
| Impact | tbc |
| Start Year | 2019 |
| Description | Trial Conduct TMRP Working group |
| Organisation | University of Aberdeen |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | na |
| Collaborator Contribution | The Trial Conduct TMRP working group is a continuation of the HTMR Network Trial conduct working group with refreshed membership, objectives and leadership - co-led by katie Gillies (Aberdeen) and Kerry Hood (Cardiff). |
| Impact | tbc |
| Start Year | 2019 |
| Description | - HSR UK 2023 oral presentation 'Improving the inclusion of an under-served group in research: development and implementation of the NIHR INCLUDE Impaired Capacity to Consent Framework' |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was an oral presentation 'Improving the inclusion of an under-served group in research: development and implementation of the NIHR INCLUDE Impaired Capacity to Consent Framework' given at HSR UK 2022. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://hsruk.org/conferences/conference-2022 |
| Description | 6th International Clinical Trials Methodology Conference 2022 |
| 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 | ICTMC is the leading international platform for researchers and practitioners to present the very latest in trials methodology research. The meeting also offers valuable networking and training opportunities. This year, 850 people attended from 20 countries worldwide. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://ictmc.org/ |
| Description | ACTA (Australian Clinical Trials Alliance), Keynote Speaker, November 2023 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Other audiences |
| Results and Impact | ACTA (Australian Clinical Trials Alliance), Keynote Speaker, November 2023 |
| Year(s) Of Engagement Activity | 2023 |
| Description | Bristol Sequential Learning Workshop |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Postgraduate students |
| Results and Impact | The Bristol Sequential Learning Workshop is a two day event held on 23rd and 34th June 2022. The workshop offered an opportunity to discuss the field of Sequential Learning. It was aimed at PhD and other graduate students. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.bristol.ac.uk/maths/events/2022/bristol-sequential-learning-workshop.html |
| Description | Conference poster |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | A poster presented at the AIDS conference, 29 Jul - 2 Aug, Montreal, Canada: Nalubega S, Osuwat L, Poku O, Agyeiwaa B, Evans C, Bosco J, Matovu J. The practice of pilot/feasibility studies in informing the conduct of HIV clinical trials in sub-Saharan Africa: a scoping review |
| Year(s) Of Engagement Activity | 2022 |
| Description | Conference poster |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | A poster presented at the Global Health Network Conference 24-25 Nov 2022, Cape Town, SA: Chepkirui M, Kimego D, Opondo C, Agweyu A. Implementation of a short message service for randomisation in a multisite pragmatic factorial clinical trial in Kenya |
| Year(s) Of Engagement Activity | 2022 |
| Description | Conference poster |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | A poster presented at the Global Health Network Conference 24-25 Nov 2022, Cape Town, SA: Erasmus-Classen LA, Hopewell S, Myers B, Siegfried N. Cultural competency: An evaluation of secondary data analysis from a South African cluster randomised controlled trial and the implications for trial reporting standards |
| Year(s) Of Engagement Activity | 2022 |
| Description | Exhibition stand for ICTMC 2019 - representing HTMR Network and TMRP |
| 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 | GC covered a stand at ICTMC 2019 promoting and disseminating information regarding HTMR Network research and the launch of TMRP |
| Year(s) Of Engagement Activity | 2019 |
| Description | Exhibition stand for Liverpool Clinical Trial Reseach Unit and SPARK Launch day 231019 |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Promotion and dissemination of HTMR Network and TMRP to a wide audience interested in clinical trials - with various levels of experience executing clinical trials - verbally and with hand out |
| Year(s) Of Engagement Activity | 2019 |
| Description | Glasgow Clinical Trials Unit Showcase - keynote speaker |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | Lots of question and discussion following the talk. |
| Year(s) Of Engagement Activity | 2020 |
| Description | HIWG Annual Meeting January 2021 |
| 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 | 160 delegates registered to attend a one-day meeting hosted online by the Health Informatics Working Group with peak attendance at over 100 delegates. Feedback from the event has been positive and has increased awareness and understanding of TMRP. |
| Year(s) Of Engagement Activity | 2021 |
| Description | HRB TMRN webinar 'Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups' |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was an HRB TMRN webinar entitled 'Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups.' It was held on 24th March 2023. |
| Year(s) Of Engagement Activity | 2023 |
| Description | HSR UK 2022 workshop 'Exploring opportunities to make trials more inclusive to under-served groups' |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a workshp delivered at HSR UK 2022. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://hsruk.org/conferences/conference-2022 |
| Description | Keynote for Glasgow Clinical Trials Collaborations Annual Meeting |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | Keynote presentation by Matthew Sydes on Data-enabled trials at Glasgow Clinical Trials Collaborations Annual Meeting. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Keynote for UCCRC ISOG |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation by Matthew Sydes (Nov 2022) to UKCRC IS and Data Management Leads national meeting on Data-enabled trials and implications for data management. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Identifying resident-related barriers and facilitators to recruiting UK care home residents in research: a scoping review |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Identifying resident-related barriers and facilitators to recruiting UK care home residents in research: a scoping review by Brittany Nocivelli. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Improving the inclusion of an under-served group in trials: development of the INCLUDE Impaired Capacity to Consent Framework |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Improving the inclusion of an under-served group in trials: development of the INCLUDE Impaired Capacity to Consent Framework by Vicky Shepherd. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Is clinical trial remote comparable to on-site monitoring? |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Is clinical trial remote comparable to on-site monitoring? Sharon Love. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Lack of Transparent Reporting of Trial Monitoring Approaches in Randomised Controlled Trials: A Systematic Review of Contemporary Protocol Papers |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Lack of Transparent Reporting of Trial Monitoring Approaches in Randomised Controlled Trials: A Systematic Review of Contemporary Protocol Papers. Vicki Yorke-Edwards |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Measuring the quality of proxy consent decisions for adults who lack capacity to consent: development of the Combined Scale for Proxy Informed Consent Decisions (CONCORD) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Measuring the quality of proxy consent decisions for adults who lack capacity to consent: development of the Combined Scale for Proxy Informed Consent Decisions (CONCORD) by Vicky Gardner. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Methodological and ethical considerations for designing Studies Within a Trial (SWATs) of recruitment interventions for trials involving adults lacking capacity to consent |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Methodological and ethical considerations for designing Studies Within a Trial (SWATs) of recruitment interventions for trials involving adults lacking capacity to consent by Vicky Shepherd. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Participant retention in paediatric randomized controlled trials: systematic review and meta-analysis |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Participant retention in paediatric randomized controlled trials: systematic review and meta-analysis by Daisy Gaunt. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Proof of concept evaluation of an electronic payment card (Clincard) for reimbursement of Patient and Public involvement (PPI) Contributors |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented by Shaun Treweek at ICTMC 2022: Proof of concept evaluation of an electronic payment card (Clincard) for reimbursement of Patient and Public involvement (PPI) Contributors. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Retention to paediatric randomized controlled trials during the COVID-19 pandemic: a qualitative study |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC: Retention to paediatric randomized controlled trials during the COVID-19 pandemic: a qualitative study. Daisy Gaunt. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Selecting and collecting outcomes for clinical trials: An international qualitative study exploring stakeholder perspectives |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC by Heidi Gardner Selecting and collecting outcomes for clinical trials: An international qualitative study exploring stakeholder perspectives. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: The INCLUDE Socioeconomic Disadvantage Framework - a tool to help researchers design and conduct more inclusive clinical trials |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: The INCLUDE Socioeconomic Disadvantage Framework - a tool to help researchers design and conduct more inclusive clinical trials. By Heidi Gardner. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: The INCLUDE Socioeconomic Disadvantage Framework - a tool to help researchers design and conduct more inclusive clinical trials. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a poster session presented at the International Clinical Trials Methodology Conference, Harrogate, UK. Gardner, H., Biggs, K., NIHR INCLUDE Socioeconomic Disadvantage Framework Public Contributor Group & Sherratt, F. C. (2022). The INCLUDE Socioeconomic Disadvantage Framework - a tool to help researchers design and conduct more inclusive clinical trials. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Poster Presented at ICTMC 2022: Understanding why ethnic minority groups are underrepresented in trials through a rapid Qualitative Evidence Synthesis (QES) and mapping evidence to find solutions |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Poster presented at ICTMC 2022: Understanding why ethnic minority groups are underrepresented in trials through a rapid Qualitative Evidence Synthesis (QES) and mapping evidence to find solutions by Heidi Gardner. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC 20220 Subgroup analyses for continuous variables: A review of methods in randomised controlled trials S. Faye Williamson |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 20220 Subgroup analyses for continuous variables: A review of methods in randomised controlled trials S. Faye Williamson |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC 2022: A good use of time? Providing evidence for how effort is invested in primary and secondary outcome data collection in trials |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 2022: A good use of time? Providing evidence for how effort is invested in primary and secondary outcome data collection in trials by Heidi Gardner. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC 2022: A whole greater than the sum of its parts': synergies and outputs of a trials' conduct working group focused on Complex and Alternate Consent pathways |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 2022 : A whole greater than the sum of its parts': synergies and outputs of a trials' conduct working group focused on Complex and Alternate Consent pathways by Julia Wade. |
| Year(s) Of Engagement Activity | Pre-2006,2022 |
| Description | Presentation at ICTMC 2022: Beyond "must speak English": Systematic review of language-related eligibility criteria inpatient recruitment to trials. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 2022: Beyond "must speak English": Systematic review of language-related eligibility criteria inpatient recruitment to trials by Talia Isaacs. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC 2022: The Trials Communication Wheel: stakeholders to consider in the lifecycle of the trial. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a presentation given at ICTM 2022: The Trials Communication Wheel: stakeholders to consider in the lifecycle of the trial. Frances Shiely, Andrew Willis, Ratna Sohanpal, Vincent Russell, Annabelle South, Talia Isaacs on behalf of the Communication Sub-Working Group of the MRC-NIHR-TMRP Trial Conduct Working Group. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC 2022: What is the purpose of clinical trial monitoring? |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Talk at ICTMC 2022 by Sharon Love. What is the purpose of clinical trial monitoring? |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC: Core outcome sets: Bridging the gap between research and routine care |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a talk given at ICTMC 2022: Anna Kearney, Core outcome sets: Bridging the gap between research and routine care. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC: Developing principles for a more comprehensive, modernised approach to managing clinical trial participation changes through the UKCRC Registered CTU Network's PeRSEVERE project |
| 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 Will Cragg for ICTMC 2022: Developing principles for a more comprehensive, modernised approach to managing clinical trial participation changes through the UKCRC Registered CTU Network's PeRSEVERE project. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC: Improving follow-up and retention to paediatric randomized controlled trials: a qualitative study |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 2022 Improving follow-up and retention to paediatric randomized controlled trials: a qualitative study by Daisy Gaunt. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation at ICTMC: Shining a light into the 'black box of horrendousness': a qualitative study exploring barriers and facilitators to conducting trials involving adults lacking capacity to consent |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation at ICTMC 2022 Shining a light into the 'black box of horrendousness': a qualitative study exploring barriers and facilitators to conducting trials involving adults lacking capacity to consent - by Vicky Shepherd. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation of TMRP Global Health Working Group to EDCTP |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | A presentation about the Global Health Working Group of the MRC-NIHR Trials Methodology Research Partnership, offering a gateway for researchers in low and middle income countries to better contribute to and benefit from developments in this field. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://az659834.vo.msecnd.net/eventsairwesteuprod/production-edctpforum-public/df5a0c7a34734920971b... |
| Description | Prof Paula Williamson: Presentation on the TMRP to the European Association of Science Editors, May 2022 (online) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | This was a presentation given by Prof. Paula Williamson on the TMRP to the European Association of Science Editors |
| Year(s) Of Engagement Activity | 2022 |
| Description | Prof. Paula Williamson, Montreal Jewish General Hospital Epidemiology Seminar, November 2022 (online) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a presentation given by Prof. Paula Williamson at the Montreal Jewish General Hospital Epidemiology Seminar. |
| Year(s) Of Engagement Activity | 2022 |
| Description | TMRP webinar 6 17 May 2023 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | In this webinar, Megan McCarthy and Catherine Houghton presented the findings of the QUALSHARE project funded by the Health Research Board-Trial Methodology Research Network (HRB-TMRN). This study, conducted in the UK and Ireland, explored existing qualitative data sharing practices in trials, and perceived issues and opportunities. |
| Year(s) Of Engagement Activity | 2023 |
| Description | TMRP/Global Health Network webinar Informed consent complexities and ways forward: methodological work from around the globe. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was a working group seminar delivered on 27th March 2023: Informed consent complexities and ways forward: methodological work from around the globe. |
| Year(s) Of Engagement Activity | 2023 |
| Description | Talk at Imperial College London Event |
| 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 | Sofia Villar presentation at Imperial Event: Connecting Multi-armed Bandit Problems, Index Policies and Clinical Trial Design. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://www.imperial.ac.uk/events/156740/sofia-villar-and-nicolo-cesa-bianchi/ |
| Description | The INCLUDE Socioeconomic Disadvantage Framework - A launch webinar |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | The INCLUDE Socioeconomic Disadvantage Framework was launched in December 2022 and a launch webinar held 24.01.23 with 280 registrants. Heidi Gardner, Katie Biggs and Frances Sherratt hosted. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://www.trialforge.org/trial-forge-centre/socioeconomic-disadvantage-framework |
| Description | Webinar "Serving the under-served better: lessons learnt from efforts to widen inclusion in trial populations" |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | The webinar addressed the issue of widening inclusion in trial populations. All of the presenters are involved with the development of frameworks to increase inclusion of under-served groups, specifically people from ethnic minority groups, people who are socio-economically disadvantaged and people who have impaired capacity. They will briefly outline these frameworks but primarily focus on the numerous and complex barriers under-served groups face in participating in clinical research, the opportunities to increase inclusion of these underserved groups, and the role the frameworks may have in supporting greater inclusion. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.hrb-tmrn.ie/online-material-info/webinar-serving-the-under-served-better-lessons-learnt-... |