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Gongfu Zhou

Incyte Corporation



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Kevin Hou

Incyte Corporation



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Yufan Zhao

Incyte Corporation



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259 – Clinical Trial Design II

Influence of Prior on Bayesian Sample Size Calculation

Sponsor: Biopharmaceutical Section
Keywords: Prior, Sample Size, Robust

Gongfu Zhou

Incyte Corporation

Kevin Hou

Incyte Corporation

Yufan Zhao

Incyte Corporation

Bayesian designs have been increasingly used in clinical development, especially in phases I and II trials. In this article, we focus on sample size calculation for single arm trials with response rate as the primary endpoint. We implement the predictive expectation criterion to account for all possible trial outcomes, therefore avoid the need to hypothesize the trial outcome. We evaluate the property of our approach under similar setting as Mayo and Gajewski (2004). Our result is comparable with that of Mayo and Gajewski (2004), and seems slightly more robust.

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