当前位置: X-MOL 学术Clin. Trials › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
An ethics framework for consolidating and prioritizing COVID-19 clinical trials
Clinical Trials ( IF 2.7 ) Pub Date : 2021-02-02 , DOI: 10.1177/1740774520988669
Michelle N Meyer 1 , Luke Gelinas 2 , Barbara E Bierer 3 , Sara Chandros Hull 4 , Steven Joffe 5, 6 , David Magnus 7 , Seema Mohapatra 8 , Richard R Sharp 9 , Kayte Spector-Bagdady 10 , Jeremy Sugarman 11 , Benjamin S Wilfond 12 , Holly Fernandez Lynch 5, 6
Affiliation  

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.



中文翻译:

用于整合和优先考虑 COVID-19 临床试验的伦理框架

鉴于缺乏既定的安全有效的干预措施来应对 COVID-19,开展有意义的临床研究迫在眉睫。好消息是,待测试的干预措施并不短缺。不幸的是,进行这些试验所需的人力和物力资源是有限的。至关重要的是,试验必须稳健并满足入组目标,并且不允许低质量的研究取代高质量的研究,从而延迟关键问题的答案。然而,除了少数例外,现有的研究审查机构和流程并不是为了确保满足这些条件而设计的。为了应对这一挑战,我们为研究机构提供有关如何在道德上整合和优先考虑 COVID-19 临床试验的指南,同时认识到整合和优先考虑也应该在上游(制造商和资助者之间)和更高级别(例如全国范围内)进行。在我们提出的三阶段过程中,试验必须首先满足阈值标准。那些确实这样做的机构将在第二阶段进行评估,以确定该机构是否有足够的能力支持所有拟议的试验。如果没有,第三阶段需要根据另外两套比较优先顺序标准来评估研究:特定于研究的标准和旨在促进机构研究组合多样化的标准。为了公平地执行这些标准,我们建议研究机构成立 COVID-19 研究优先委员会。我们借鉴作者在各自机构的经验,简要讨论了这些委员会的一些重要属性。尽管我们专注于 COVID-19 疗法的临床试验,但我们的指南应该对其他类型的 COVID-19 研究以及非流行病研究有用,因为研究资源稀缺,这些研究可能会带来类似的挑战。

更新日期:2021-02-03
down
wechat
bug