Group sequential multi-arm multi-stage trial design with treatment selection

被引:3
作者
Wu, Jianrong [1 ,4 ]
Li, Yimei [2 ]
Zhu, Liang [3 ]
机构
[1] Univ New Mexico, Div Epidemiol Biostat & Prevent Med, Albuquerque, NM USA
[2] St Jude Childrens Res Hosp, Dept Biostat, Memphis, TN USA
[3] Univ Texas Hlth Sci Ctr, Internal Med, Houston, TX USA
[4] 1 Univ New Mexico, Div Epidemiol, Biostat, Prevent Med, Albuquerque, NM 87131 USA
关键词
group sequential design; multi-arm multi-stage trial; sample size calculation; sequential conditional probability ratio test; PROBABILITY RATIO TESTS; CLINICAL-TRIALS;
D O I
10.1002/sim.9682
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
A multi-arm trial allows simultaneous comparison of multiple experimental treatments with a common control and provides a substantial efficiency advantage compared to the traditional randomized controlled trial. Many novel multi-arm multi-stage (MAMS) clinical trial designs have been proposed. However, a major hurdle to adopting the group sequential MAMS routinely is the computational effort of obtaining total sample size and sequential stopping boundaries. In this paper, we develop a group sequential MAMS trial design based on the sequential conditional probability ratio test. The proposed method provides analytical solutions for futility and efficacy boundaries to an arbitrary number of stages and arms. Thus, it avoids complicated computational effort for the methods proposed by Magirr et al. Simulation results showed that the proposed method has several advantages compared to the methods implemented in R package MAMS by Magirr et al.
引用
收藏
页码:1480 / 1491
页数:12
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