摘要新型冠状病毒肺炎出现以来，席卷了全球各个国家和地区，安全且有效的新型冠状病毒肺炎疫苗是控制新型冠状病毒肺炎疫情最有效手段之一。新型冠状病毒肺炎疫苗的关键性临床研究通常采用安慰剂对照的保护效力试验，以观察疫苗是否可以有效降低疾病的发病率。本文即将对新冠疫苗保护效力临床试验中研究设计和研究终点的考量、统计学评价方法、主要估计目标的选择以及针对不同伴发事件的解决策略等进行介绍和探讨。

abstractsThe COVID-19 swept across the countries and regions all over the world in the past one year. The marketing of an effective and safe COVID-19 vaccine is expected to control the spread of the disease. A placebo-controlled field efficacy trial is generally considered in the pivotal study of COVID-19 vaccine to observe whether it is able to reduce the incidence rate of the disease effectively. This paper is to introduce and discuss the considerations in study design and the choice of endpoint, statistical evaluation methods, primary estimand choosing and the strategies to various intercurrent events in the COVID-19 efficacy trials.