Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 22, Issue 4, Pages 836-852Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2010.528104
Keywords
Minimax design; Optimal design; Two-stage designs
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Funding
- UK Medical Research Council [G08008600, U.1052.00.014]
- Medical Research Council [MC_EX_G0800860] Funding Source: researchfish
- MRC [MC_EX_G0800860] Funding Source: UKRI
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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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