GROUP SEQUENTIAL METHODS IN DESIGN AND ANALYSIS OF CLINICAL-TRIALS
成果类型：
Article
署名作者：
POCOCK, SJ
署名单位：
University of Edinburgh
刊物名称：
BIOMETRIKA
ISSN/ISSBN：
0006-3444
DOI：
10.1093/biomet/64.2.191
发表日期：
1977
页码：
191200
关键词：
摘要：
In clinical trials with sequential patient entry, fixed sample size designs are unjustified on ethical grounds and sequential designs are often impracticable. One solution is a group sequential design dividing patient entry into a number of equal-sized groups so that the decision to stop the trial or continue is based on repeated significance tests of the accumulated data after each group is evaluated. Exact results are obtained for a trial with 2 treatments and a normal response with known variance. The design problem of determining the required size and number of groups is also considered. Simulation shows that these normal results may be adapted to other types of response data. An example shows that group sequential designs can sometimes be statistically superior to standard sequential designs.