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- WasonJames M SJMMRC Biostatistics Unit Hub for Trials Methodology Research, Cambridge, United Kingdom. james.wason@mrc-bsu.cam.ac.uk and Adrian P Mander.
- MRC Biostatistics Unit Hub for Trials Methodology Research, Cambridge, United Kingdom. james.wason@mrc-bsu.cam.ac.uk
- J Biopharm Stat. 2012 Jan 1; 22 (4): 836-52.
AbstractTwo-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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