Bayesian enhancement two-stage design for single-arm phase II clinical trials with binary and time-to-event endpoints.
Biometrics 2018 Feb 21. Epub 2018 Feb 21.
Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong.
Simon's two-stage design is one of the most commonly used methods in phase II clinical trials with binary endpoints. The design tests the null hypothesis that the response rate is less than an uninteresting level, versus the alternative hypothesis that the response rate is greater than a desirable target level. From a Bayesian perspective, we compute the posterior probabilities of the null and alternative hypotheses given that a promising result is declared in Simon's design. Read More