新冠肺炎应急临床试验设计中的统计学考虑

新型冠状病毒肺炎的突然来袭，国内各地相继启动重大突发公共卫生事件一级响应。为了探索新冠肺炎的治疗，百余项临床研究陆续在国内开展。在突发公共卫生事件下，尽早找到有效的药物和治疗方案对于疾病的控制更加重要，这也对在这种应急情况下所开展临床试验的时效性提出要求，尤其是针对新冠肺炎的注册临床试验。本文从统计学角度，对应急临床试验中临床终点的选择和试验设计中的相关问题进行探讨。

Statistical consideration in the design of COVID-19 clinical trials in emergency

The outbreak of coronavirus disease 2019 (COVID-19) led to the first-level response to major public health emergencies in China. To explore the therapy of COVID-19, hundreds of clinical studies were conducted. For major public health emergencies, it is important to find out the effective drug and therapeutic regimen as soon as possible for the control of disease, which raises the claim of timeliness to the trials conducted in emergency, especially to the registered clinical trials. This paper discusses the choice of clinical endpoint and related questions in the design of clinical trials in emergency from the statistical perspective.