MINIMIZING THE MAXIMUM EXPECTED SAMPLE SIZE IN TWO-STAGE PHASE II CLINICAL TRIALS WITH CONTINUOUS OUTCOMES

被引:14
|
作者
Wason, James M. S. [1 ]
Mander, Adrian P. [1 ]
机构
[1] MRC Biostat Unit Hub Trials Methodol Res, Cambridge, England
基金
英国医学研究理事会;
关键词
Minimax design; Optimal design; Two-stage designs; CONDITIONAL POWER; DESIGNS; CANCER;
D O I
10.1080/10543406.2010.528104
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Two-stage designs are commonly used for Phase II trials. Optimal two-stage designs have the lowest expected sample size for a specific treatment effect, for example, the null value, but can perform poorly if the true treatment effect differs. Here we introduce a design for continuous treatment responses that minimizes the maximum expected sample size across all possible treatment effects. The proposed design performs well for a wider range of treatment effects and so is useful for Phase II trials. We compare the design to a previously used optimal design and show it has superior expected sample size properties.
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页码:836 / 852
页数:17
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