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新冠疫情如何从根本上改变了全球健康领域的临床研究。

How COVID-19 has fundamentally changed clinical research in global health.

机构信息

Department of Experimental Medicine, University of British Columbia, Vancouver, BC, Canada.

Bill & Melinda Gates Medical Research Institute, Boston, MA, USA.

出版信息

Lancet Glob Health. 2021 May;9(5):e711-e720. doi: 10.1016/S2214-109X(20)30542-8.

Abstract

COVID-19 has had negative repercussions on the entire global population. Despite there being a common goal that should have unified resources and efforts, there have been an overwhelmingly large number of clinical trials that have been registered that are of questionable methodological quality. As the final paper of this Series, we discuss how the medical research community has responded to COVID-19. We recognise the incredible pressure that this pandemic has put on researchers, regulators, and policy makers, all of whom were doing their best to move quickly but safely in a time of tremendous uncertainty. However, the research community's response to the COVID-19 pandemic has prominently highlighted many fundamental issues that exist in clinical trial research under the current system and its incentive structures. The COVID-19 pandemic has not only re-emphasised the importance of well designed randomised clinical trials but also highlighted the need for large-scale clinical trials structured according to a master protocol in a coordinated and collaborative manner. There is also a need for structures and incentives to enable faster data sharing of anonymised datasets, and a need to provide similar opportunities to those in high-income countries for clinical trial research in low-resource regions where clinical trial research receives considerably less research funding.

摘要

COVID-19 对全球人口产生了负面影响。尽管有一个共同的目标,应该整合资源和努力,但已经注册了大量方法学质量值得怀疑的临床试验。作为本系列的最后一篇论文,我们讨论了医学研究界对 COVID-19 的反应。我们认识到这场大流行给研究人员、监管机构和政策制定者带来了难以置信的压力,他们都在尽最大努力在巨大的不确定性中快速而安全地行动。然而,研究界对 COVID-19 大流行的反应突出了在当前系统及其激励结构下临床试验研究中存在的许多根本问题。COVID-19 大流行不仅再次强调了精心设计的随机临床试验的重要性,还强调了需要以协调和协作的方式根据主方案进行大规模临床试验。还需要建立结构和激励机制,以实现匿名数据集的快速数据共享,并为临床试验研究提供类似的机会,这些机会应该在资源较少的地区提供,因为这些地区的临床试验研究获得的研究资金要少得多。

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