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Activity Number:
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263
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2016 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #319019
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Title:
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Optimal Sample Size Determination for Adaptive Seamless Phase II/III Design
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Author(s):
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Zhongying Xu* and John A. Kellum and Gary M. Marsh and Chung-Chou H. Chang
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Companies:
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University of Pittsburgh and University of Pittsburgh and University of Pittsburgh and University of Pittsburgh
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Keywords:
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adaptive seamless design ;
closed testing principle ;
combination test ;
sample size determination ;
treatment selection
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Abstract:
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The adaptive seamless phase II/III design combines the conventional separate phases II and III trials into a single trial, and it allows adaptations (e.g. sample size reassessment and early stopping for futility or success) after the interim analysis. In this study, we propose a simulation-based method to determine the optimal sample size for the adaptive seamless phase II/III design. We assume a power law relationship exists between the overall sample size and statistical power of the final test. The optimal sample size is defined as the minimum sample size that provides adequate power with overall type I error rate under control. We take correlations between the early and the final outcomes into consideration in the final analysis. The methodology is applied to determine sample sizes in a study for a treatment that can avoid renal damage during cardiac operations while the most effective dose of the treatment will be selected at the interim analysis.
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Authors who are presenting talks have a * after their name.
