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

Nan Sun, Junjiang Zhong, Miin Jye Wen

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)415-431
Number of pages17
JournalCommunications in Statistics - Theory and Methods
Volume50
Issue number2
DOIs
Publication statusPublished - 2021

All Science Journal Classification (ASJC) codes

  • Statistics and Probability

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