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Activity Number: 239 - Study Design and Analysis for Complex Survival Data
Type: Contributed
Date/Time: Monday, July 29, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract #304296
Title: Group Sequential Design for Trials with Time-To-Event Endpoint Using the Proportional Time Assumption
Author(s): Milind Phadnis*
Companies: University of Kansas Medical Center
Keywords: alpha spending; beta spending; efficacy; futility; proportional time; sample size

A Group Sequential design allows researchers to perform interim monitoring after groups of patients have completed the study. Literature is well developed for continuous and binary outcomes and relies on asymptotic normality of the test statistic. However, in the case of time-to-event endpoint, existing methods of sample size calculation are done either assuming proportional hazards or exponentially distributed lifetimes. In scenarios where these assumptions are not true, as evidenced from historical data, these traditional methods are restrictive and cannot always be used. As interim monitoring is driven by ethical, financial, and administrative considerations, it is imperative that sample size calculations be done in an efficient manner keeping in mind the specific needs of a clinical trial with a time-to-event outcome. To address these issues, a novel group sequential design is proposed using the concept of Proportional Time. The design incorporates features specific to survival data such as loss to follow-up, administrative censoring, varying accrual times and patterns, binding or non-binding futility rules with or without skips, and flexible alpha and beta spending mechanisms.

Authors who are presenting talks have a * after their name.

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