Sample size reassessment in adaptive clinical trials using a bias corrected estimate

被引:13
作者
Coburger, S [1 ]
Wassmer, G [1 ]
机构
[1] Univ Cologne, Inst Med Stat Informat & Epidemiol, Cologne, Germany
关键词
point estimation; group sequential test designs; adaptive designs; early stopping; sample size reassessment; GROUP SEQUENTIAL METHODS; HYPOTHESIS; DESIGNS; POINT; TESTS;
D O I
10.1002/bimj.200390051
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Point estimation in group sequential and adaptive trials is an important issue in analysing a clinical trial. Most literature in this area is only concerned with estimation after completion of a trial. Since adaptive designs allow reassessment of sample size during the trial, reliable point estimation of the true effect when continuing the trial is additionally needed. We present a bias adjusted estimator which allows a more exact sample size determination based on the conditional power principle than the naive sample mean does.
引用
收藏
页码:812 / 825
页数:14
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