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

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 Baye...

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Bibliographic Details
Published inCommunications in statistics. Theory and methods Vol. 50; no. 2; pp. 415 - 431
Main Authors Sun, Nan, Zhong, Junjiang, Wen, Miin-Jye
Format Journal Article
LanguageEnglish
Published Philadelphia Taylor & Francis 17.01.2021
Taylor & Francis Ltd
Subjects
Bayesian analysis
Bayesian error rates
continuous endpoints
Design parameters
Hypotheses
Single-to-double arm design
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Summary: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.
Bibliography:ObjectType-Article-1
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ISSN:0361-0926
1532-415X
DOI:10.1080/03610926.2019.1635702