Trials Methodology Research Partnership

临床试验对于检验一种新疗法是否对患者有益至关重要。每年都有数以万计的新的临床试验开始，由公共和私营部门资助。无论是在资金方面，还是在患者和医疗系统的负担方面，试验都非常昂贵。因此，尽可能高效地进行临床试验是很重要的。在英国和爱尔兰，有几个不同的研究小组从事临床试验。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具有丰富的专业知识。这项资助的目的是将这些研究人员聚集在一起，作为试验方法研究伙伴关系。这一新的伙伴关系将侧重于需要改进临床试验的主要领域，以帮助增进社会健康。该合作伙伴关系将由一个执行委员会组成，该委员会将监督8个工作组。这些小组将各自处理一个改进试验的主要领域。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，以及如何确保最佳方法可以用于真正的临床试验。工作组将为重点项目提出新的资助建议。组成这一合作伙伴关系的各团体都承诺为一名攻读临床试验方法学博士学位的研究生提供资金。这些学生将为合作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，这些项目与该伙伴关系的主要优先事项有关。第一个重点是分层医学。这是为了提高人们对新疗法对哪些患者有效的认识，使他们能够接受最好的治疗。当一种治疗方法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用。由该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。这个试点项目将导致一个更大的项目，将为其提出单独的拨款申请。第二个重点是卫生信息学。这是利用新的数字技术来改进审判。卫生信息学在降低试验成本和增加可获得的信息量方面具有巨大的潜力。与第一个焦点相联系，更多的高质量信息可能导致更好的患者分层。卫生信息学工作组将举行一次讲习班，汇集这一领域的专门知识。这将导致识别方法问题，这些问题可以在未来使用数字技术的试验中进行测试。第三个重点是全球卫生试验。许多疾病在低收入和中等收入国家变得越来越常见。仅在中低收入国家进行的临床试验很常见，但往往很难做到。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LMIC研究人员与英国和爱尔兰的研究人员之间的国际合作，从而帮助实现这一目标。该伙伴关系还将帮助支持使英国试验方法学研究受益的成功倡议，如COMET倡议、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发展。这将开发一个新的可持续的试验研究组合，以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有效，并改善全世界的医疗保健。

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.