Sample size optimization and initial allocation of the significance levels in group sequential trials with multiple endpoints

被引:6
作者
Gou, Jiangtao [1 ]
机构
[1] Villanova Univ, Dept Math & Stat, Villanova, PA 19085 USA
关键词
multiple tests; multistage designs; power; sample size; trigger; CLOSED TESTING PROCEDURES; CLINICAL-TRIALS; DESIGN; BONFERRONI; FRAMEWORK; FAMILY; SIMES; POWER;
D O I
10.1002/bimj.202000081
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
We consider multistage tests of multiple hypotheses under a flexible setting of calendar time and information fraction, focusing on the case where there are two hypotheses under testing. Explicit expressions of statistical powers are derived. With a proof of existence and uniqueness of solution, we develop a numerical method to search the optimal sample size. The proposed method allows us to find the suitable allocation of initial significance level along with the minimum sample size for group sequential designs, with and without hierarchical structures among different endpoints.
引用
收藏
页码:301 / 311
页数:11
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