Survival analysis following dynamic randomization

Abstract

In this paper, we propose a method to analyze survival data from a clinical trial that utilizes a dynamic randomization for subject enrollment. The method directly accounts for dynamic subject randomization process using a marked point process (MPP). Its corresponding martingale process is used to formulate an equation for estimating the treatment effect size and for hypothesis testing. We perform simulation analyses to evaluate the outcomes of the proposed method as well as the conventional log rank method and re-randomized testing procedure.