Trials Methodology Research Partnership

试验方法研究合作伙伴

• 批准号: MR/S014357/1
• 负责人: Paula Williamson
• 金额: $ 50.36万
• 依托单位: University of Liverpool
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FS014357%2F1
• 关键词: Trials; Methodology; Research; Partnership

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.

临床试验对于测试新疗法是否为患者带来益处至关重要。每年都会启动数以万计的新临床试验，由公共和私营部门资助。试验的费用非常昂贵，无论是在金钱方面，还是对患者和医疗保健系统的负担。因此，尽可能高效地进行临床试验非常重要。在英国和爱尔兰，有几个不同的研究人员小组从事临床试验。这些小组在如何进行更有效和信息丰富的试验的特定领域拥有丰富的专业知识。这笔赠款的目的是将这些研究人员聚集在一起，形成试验方法学研究合作伙伴关系。这一新的合作伙伴关系将重点关注需要改进临床试验的主要领域，以帮助提高社会健康。该伙伴关系将由一个执行委员会组成，负责监督八个工作组。这些小组将各自致力于改进试验的一个主要领域。每个工作组将由英国各地的专家组成，他们将确定该领域需要哪些新工作，以及如何确保在真正的临床试验中使用最佳方法。工作组将为重点项目汇总新的资助提案。组成合作伙伴关系的各个小组均承诺资助一名将攻读临床试验方法学博士学位的研究生。这些学生将为实现伙伴关系的目标做出贡献。这笔赠款将为建立和协调伙伴关系及其工作组提供资金。它还将为三个较小的研究项目提供资金，这些项目与合作伙伴关系的主要优先事项相关。第一个重点是分层医学。这是为了提高对新疗法对哪些患者有效的了解，使他们能够接受最好的治疗。当治疗对不同类型的患者有不同的效果时，进行临床试验的典型方法可能不适合。该合作伙伴关系资助的一个试点项目将审查未来需要哪些试验研究来帮助更好地对患者进行分层。该试点项目将导致一个更大的项目，并将为此单独提出赠款申请。第二个重点是健康信息学。这是利用新的数字技术来改进试验。健康信息学在降低试验成本和增加试验信息量方面具有巨大潜力。与第一个焦点相关，更多高质量的信息可能会导致更好的患者分层。健康信息学工作组将举办一次研讨会，汇集该领域的专业知识。这将导致确定可以在未来利用数字技术的试验中进行测试的方法学问题。第三个重点是全球健康试验。许多疾病在低收入和中等收入国家 (LMIC) 中变得越来越常见。仅在中低收入国家进行的临床试验很常见，但往往很难进行。全球卫生工作组将制定研究项目来解决这些困难。它将通过提供小额赠款来鼓励中低收入国家研究人员与英国和爱尔兰研究人员之间的国际合作来帮助实现这一目标。该伙伴关系还将帮助支持有利于英国试验方法研究的成功举措，例如COMET计划、国际临床试验方法学会议和最佳试验实践在线指导包。该伙伴关系将支持进一步具体项目赠款的开发。这将开发一个新的可持续试验研究组合，确保英国和爱尔兰处于试验方法研究的前沿。由此产生的研究将使试验更加高效并改善全球医疗保健。

项目成果

Irish funder guidance increased searching for, and uptake of, core outcome sets.

爱尔兰资助者的指导增加了对核心成果集的搜索和采用。

• DOI: 10.1016/j.jclinepi.2023.03.019
• 发表时间: 2023
• 期刊: Journal of clinical epidemiology
• 影响因子: 7.2
• 作者: Beecher C

Additional file 2 of What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives

随机试验中影响保留沟通的附加文件 2：探索试验人员观点的多试验、基于理论的分析

• DOI: 10.6084/m9.figshare.20626400
• 发表时间: 2022
• 作者: Coffey T

Patient participation in Delphi surveys to develop core outcome sets: systematic review.

患者参与Delphi调查以开发核心结果集：系统评价。

• DOI: 10.1136/bmjopen-2021-051066
• 发表时间: 2021-09-02
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Barrington H;Young B;Williamson PR
• 通讯作者: Williamson PR

Utilising high-dimensional data in randomised clinical trials: a review of methods and practice

在随机临床试验中利用高维数据：方法和实践回顾

• DOI: 10.48550/arxiv.2305.10174
• 发表时间: 2023
• 作者: Cherlin S