Bayesian two-stage design for drug screening trials with switching hypothesis tests based on continuous endpoints |
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Authors: | Nan Sun Miin-Jye Wen |
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Institution: | 1. Department of Statistical Science, Fox School of Business, Temple University, Philadelphia, PA, USA;2. Department of Statistics, National Cheng Kung University, Tainan, Taiwan |
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Abstract: | AbstractIn this paper, we propose a Bayesian two-stage design with changing hypothesis test by bridging a single-arm study and a double-arm randomized trial in one phase II clinical trial based on continuous endpoints rather than binary endpoints. We have also calibrated with respect to frequentist and Bayesian error rates. The proposed design minimizes the Bayesian expected sample size if the new candidate has low or high efficacy activity subject to the constraint upon error rates in both frequentist and Bayesian perspectives. Tables of designs for various combinations of design parameters are also provided. |
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Keywords: | Single-to-double arm design continuous endpoints Bayesian error rates |
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