Sequential monitoring of covariate adaptive randomized clinical trials with sample size re-estimation

Once scientific questions are determined, other design features of clinical trials including increasing the power while controlling the type I error rate, planning interim analysis, and achieving treatment balance among subgroups will be either required or preferred. We propose to sequentially monitor the covariate adaptive randomization (CAR) procedures with sample size re-estimation (SSR) to satisfy a variety of design objectives of clinical trials. However, each of the three adaptive designs (sequential monitoring, CAR, and SSR) poses a challenge to the control of the type I error rate.

Source: Contemporary Clinical Trials - October 31, 2019 Category: Radiology Authors: Jun Yu, Dejian Lai Source Type: research