Abstract: In recent years, the group sequential design has been widely used in clinical trials, because this design can draw conclusions in advance and end the trial during the interim analysis, which has greater flexibility. This article briefly introduced this design method from the following aspects of background, design procedure, comparison with traditional clinical trials, application scenarios, case analysis, the key points of design, and reporting standards.

Key words: Group sequential design; Clinical trial; Interim analysis; α spending function

摘要： 近年来，成组序贯设计因其可在期中分析时提前得出结论结束试验，具有更强的灵活性，已被广泛应用于临床试验中。本文将从背景、设计思路、与传统临床试验的比较、使用场景、案例解读、设计要点和报告规范等对该方法进行简单介绍。

关键词: 成组序贯设计; 临床试验; 期中分析; α消耗函数