Abstract

In clinical trials, the study protocols are often amended to modify trial procedures and/or statistical methods during the conduct of the clinical trials. Major or significant modification (adaptation) could result in a shift in the target patient population and consequently lead to a totally different trial, which is unable to answer the medical or scientific questions that the trial is intended to answer. The approaches of covariate-adjusted model for continuous and binary responses have been proposed. In this paper, we propose a Bayesian approach for analysis of binary study endpoint when there is a shift in patient population after protocol amendments.

Disciplines

Clinical Trials | Statistical Methodology | Statistical Theory