Division of Infectious Diseases, St. Michael's Hospital, 30 Bond St., Toronto, ON, M5B 1W8, Canada.
MAP Centre for Urban Health Solutions, St. Michael's Hospital, 30 Bond St., Toronto, ON, M5B 1W8, Canada.
Trials. 2020 Sep 29;21(1):815. doi: 10.1186/s13063-020-04754-9.
An unprecedented volume of research has been generated in response to the COVID-19 pandemic. However, there are risks of inefficient duplication and of important work being impeded if efforts are not synchronized. Excessive reliance on observational studies, which can be more rapidly conducted but are inevitably subject to measured and unmeasured confounders, can foil efforts to conduct rigorous randomized trials. These challenges are illustrated by recent global efforts to conduct clinical trials of post-exposure prophylaxis (PEP) as a strategy for preventing COVID-19. Innovative strategies are needed to help overcome these issues, including increasing communication between the Data Safety and Monitoring Committees (DSMCs) of similar trials. It is important to reinforce the primacy of high-quality trials in generating unbiased answers to pressing prevention and treatment questions about COVID-19.
应对 COVID-19 大流行产生了前所未有的大量研究。然而，如果不进行协调，就有可能导致效率低下的重复研究，以及重要工作受阻。过度依赖观察性研究虽然可以更快地进行，但不可避免地会受到可测量和不可测量的混杂因素的影响，从而阻碍进行严格的随机试验。最近全球努力开展接触后预防 (PEP) 的临床试验以作为预防 COVID-19 的策略，就说明了这些挑战。需要创新策略来帮助克服这些问题，包括增加类似试验的数据安全和监测委员会 (DSMC) 之间的沟通。重要的是要加强高质量试验的首要地位，以针对 COVID-19 的紧迫预防和治疗问题提供无偏倚的答案。
