临床试验中的成组序贯设计  

Group Sequential Design in Clinical Trials

作　　者：胥芹 张怡君 田雪 夏雪 张晓丽 李静[1,2] 王安心 XU Qin;ZHANG Yijun;TIAN Xue;XIA Xue;ZHANG Xiaoli;LI Jing;WANG Anxin(Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;National Clinical Research Center for Neurological Diseases,Beijing 100070,China;Department of Epidemiology and Health Statistics,School of Public Health,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京天坛医院神经病学中心,北京100070 [2]国家神经系统疾病临床医学研究中心 [3]首都医科大学公共卫生学院流行病与卫生统计学系

出　　处：《中国卒中杂志》2022年第11期1283-1287,共5页Chinese Journal of Stroke

基　　金：国家重点研发计划(2022YFC3600600,2022YFC3600603);北京市自然科学基金-海淀原始创新联合基金(L222123)。

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。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.

关 键 词：成组序贯设计 临床试验 期中分析 α消耗函数 

分 类 号：R195.1[医药卫生—卫生统计学]