How COVID-19 has fundamentally changed clinical research in global health.
How COVID-19 has fundamentally changed clinical research in global health.
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DOI：
10.1016/s2214-109x(20)30542-8
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发表时间：
2021-05
期刊：
影响因子：
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通讯作者：
Mills EJ
中科院分区：
文献类型：
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作者：
Park JJH;Mogg R;Smith GE;Nakimuli-Mpungu E;Jehan F;Rayner CR;Condo J;Decloedt EH;Nachega JB;Reis G;Mills EJ
COVID-19已对全球人口造成负面影响。尽管有一个共同的目标，应该有统一的资源和努力，有一个压倒性的大量的临床试验已注册的方法质量有问题。作为本系列的最后一篇论文，我们将讨论医学研究界如何应对COVID-19。我们认识到，这场大流行病给研究人员、监管机构和政策制定者带来了巨大的压力，他们都在尽最大努力在一个充满巨大不确定性的时期迅速而安全地采取行动。然而，研究界对COVID-19大流行的反应突出了当前制度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疫情不仅再次强调了精心设计的随机临床试验的重要性，也强调了以协调和协作的方式根据主方案构建大规模临床试验的必要性。还需要建立结构和激励措施，以加快匿名数据集的数据共享，并需要为高收入国家提供类似的机会，以便在临床试验研究获得的研究资金少得多的低资源地区进行临床试验研究。
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.