GROUP SEQUENTIAL-METHODS FOR CLINICAL-TRIALS ALLOWING EARLY ACCEPTANCE OF HO AND INCORPORATING COSTS
成果类型：
Article
署名作者：
GOULD, AL; PECORE, VJ
署名单位：
Merck & Company
刊物名称：
BIOMETRIKA
ISSN/ISSBN：
0006-3444
DOI：
10.1093/biomet/69.1.75
发表日期：
1982
页码：
7580
关键词：
摘要：
When interim accumulated results from a clinical trial clearly indicate that the null hypothesis should be accepted or rejected, ethical and cost considerations may dictate terminating the trial and making the appropriate decision. Pocock (1977) described a group sequential procedure for clinical trials that permits early termination only for rejecting the null hypothesis. This paper extends Pocock''s procedure to allow early termination with acceptance of the null hypothesis. Theoretical and simulation results demonstrate that designs allowing early acceptance of the null hypothesis can have lower expected costs than designs that do not, even when the alternative hypothesis is true.