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.

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.

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.

Publications

10 25 50

 
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 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 11/2021 
End 04/2023
 
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 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 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 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. 
 
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 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 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 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 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...