Bayesian Two-Stage Design for Drug Screening Trials with Switching Hypothesis Tests based on Continuous Endpoints

Abstract

In Phase II clinical trials Simon’s (1989) two-stage design is one of the most classical and well-known designs The question Simon’s two-stage design tackles with is to test whether the response probability of an experimental drug is less than some uninteresting level which demands that the endpoints are binary Besides Simon’s design is a single-arm design Tsou et al (2008) is to test whether the mean level of efficacy of an experimental drug is less than some uninteresting level which makes itself a revision of Simon’s two-stage design in the aspect of changing binary endpoints to continuous endpoints and also a single-arm design Shi and Yin (2016) modifies Simon’s two-stage design in several aspects: the first is to change the decision rule in the first stage with the same hypothesis tested as Simon (1989) the second is to change single-arm trial to double-arm trial in the second stage and the third is to use Bayesian method to make a decision in the second stage Our design is an extension of Shi and Yin (2016) since we change the binary endpoints i e the response probability in Shi and Yin (2016) and Simon (1989) to continuous endpoints in Tsou et al (2008) which is the mean level of efficacy of a drug

Date of Award	2017 Jun 19
Original language	English
Supervisor	Miin-Jye Wen (Supervisor)