Journal de biométrie et biostatistique

Group Sequential Survival Trial Designs Against Historical Controls under the Weibull Model

Abstract

Jianrong Wu and Xiaoping Xiong

In this paper, two parametric sequential tests are proposed for historical control trial designs under the Weibull model. The proposed tests are asymptotically normal with properties of Brownian motion. The sample size formulas and information times are derived for both tests. A multi-stage sequential procedure based on sequential conditional probability ratio test methodology is proposed for monitoring clinical trials against historical controls.