Bayesian two-stage design for drug screening trials with switching hypothesis tests based on continuous endpoints

Nan Sun, Junjiang Zhong and Miin-Jye Wen

Communications in Statistics - Theory and Methods, 2021, vol. 50, issue 2, 415-431

Abstract: In 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.

Date: 2021
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Persistent link: https://EconPapers.repec.org/RePEc:taf:lstaxx:v:50:y:2021:i:2:p:415-431

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DOI: 10.1080/03610926.2019.1635702

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