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通过在临床试验中增加多样性来减少不平等——这对医疗器械与药物及治疗方法同样重要。

Reducing inequalities through greater diversity in clinical trials - As important for medical devices as for drugs and therapeutics.

作者信息

Roope Laurence S J, Walsh Jessica, Welland Maddie, Samuel Gabrielle, Johansen-Berg Heidi, Nobre Anna C, Clare Stuart, Higham Helen, Campbell Jon, Denison Tim, Miller Karla L, Fazel Seena, Costa Matthew L, Farmer Andrew, Knight Marian, Taylor Rachel, Henderson Lorna R, Vaid Angeli, Geddes John, Kiparoglou Vasiliki, McShane Helen, Clarke Philip M

机构信息

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.

National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, United Kingdom.

出版信息

Contemp Clin Trials Commun. 2025 Mar 5;45:101467. doi: 10.1016/j.conctc.2025.101467. eCollection 2025 Jun.

Abstract

In medicine and public health, the randomised controlled trial (RCT) is generally considered the key generator of 'gold standard' evidence. However, basic and clinical research and trials are often unrepresentative of real-world populations. Recruiting insufficiently diverse cohorts of participants in trials (e.g. in terms of socioeconomic status, racial and ethnic background, or sex and gender) may not only overstate the general effectiveness of a technology; it may also actively increase health inequalities. We highlight some general issues in this domain, before discussing several specific illustrative examples in the context of medical devices. High quality evidence on factors that would improve trial recruitment is extremely limited. There is a clear need for research on candidate strategies for improving recruitment of under-represented groups in RCTs. These could include, for example, offering various forms of financial incentives; non-monetary incentives, such as preferential access to the technologies that are being tested if they are found to be effective; and various types of informational messages and nudges; as well as involvement of community partners and champions in the recruitment process. Ideally, recruitment practices should ultimately be based on evidence generated from RCTs. Studies Within a Trial (SWAT), where randomised experiments are built into the actual recruitment processes in RCTs, are an ideal way to gain this evidence. SWAT studies are seeing an increase in traction, as indicated by funding streams in bodies such as the UK-based NIHR. Making greater funding available for studies of this kind is needed to improve the evidence base on how best to improve diversity in trial recruitment.

摘要

在医学和公共卫生领域,随机对照试验(RCT)通常被视为“金标准”证据的关键来源。然而,基础研究、临床研究及试验往往无法代表真实世界的人群。在试验中招募的参与者队列缺乏足够的多样性(例如在社会经济地位、种族和民族背景或性别方面),这不仅可能夸大某项技术的总体有效性;还可能会加剧健康不平等。在讨论医疗设备领域的几个具体示例之前,我们先强调一下该领域的一些普遍问题。关于能够改善试验招募情况的因素的高质量证据极为有限。显然有必要对改善随机对照试验中代表性不足群体招募情况的候选策略进行研究。这些策略可以包括,例如提供各种形式的经济激励;非货币激励,如如果所测试的技术被证明有效,可优先使用这些技术;以及各种类型的信息传递和助推手段;还有让社区合作伙伴和倡导者参与招募过程。理想情况下,招募实践最终应基于随机对照试验产生的证据。试验中的研究(SWAT),即将随机实验纳入随机对照试验的实际招募过程中,是获取此类证据的理想方式。正如英国国家健康研究所(NIHR)等机构的资金流向所示,SWAT研究正越来越受到关注。需要为这类研究提供更多资金,以完善关于如何最好地提高试验招募多样性的证据基础。

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