STUDY DURATION FOR GROUP SEQUENTIAL CLINICAL-TRIALS WITH CENSORED SURVIVAL-DATA ADJUSTING FOR STRATIFICATION

The study duration in a clinical trial with censored survival data is the sum of the accrual duration, which determines the sample size in a traditional sense, and the follow-up duration, which more or less controls the number of events to be observed. We propose a design procedure for determining the study duration or for calculating the power in a group sequential clinical trial with censored survival data and possibly unequal patient allocation between treatments, adjusting for stratified randomization. The group sequential method is based on the use function approach. We describe a clinical trial recently activated by the Eastern Cooperative Oncology Group for an illustration of the proposed procedure.