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.
Clinical Trials | Statistical Methodology | Statistical Theory
Yang, Lan-Yan; Chow, Shein-Chung; and Chi, Yun-Chan, "Bayesian Approach for Analysis of Binary Responses in Clinical Trials with Protocol Amendments" (November 2010). Duke Biostatistics and Bioinformatics (B&B) Working Paper Series. Working Paper 13.