关键词: 成组序贯设计; 临床试验; 期中分析; α消耗函数

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