Survival Analysis Commons^™

Designed Extension Of Survival Studies: Application To Clinical Trials With Unrecognized Heterogeneity, Yi Li, Mei-Chiung Shih, Rebecca A. Betensky

Harvard University Biostatistics Working Paper Series

It is well known that unrecognized heterogeneity among patients, such as is conferred by genetic subtype, can undermine the power of randomized trial, designed under the assumption of homogeneity, to detect a truly beneficial treatment. We consider the conditional power approach to allow for recovery of power under unexplained heterogeneity. While Proschan and Hunsberger (1995) confined the application of conditional power design to normally distributed observations, we consider more general and difficult settings in which the data are in the framework of continuous time and are subject to censoring. In particular, we derive a procedure appropriate for the analysis of …