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Activity Number: 339 - SPEED: Biopharmaceutical and General Health Studies: Statistical Methods and Applications, Part 1
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #306952 Presentation
Title: Criteria for Choosing a Futility Method for Clinical Studies
Author(s): Richard McNally*
Companies: Covance-Chiltern
Keywords: Group sequential designs; Interim analysis; Futility; Adaptive designs; Power and sample size; Bayes rule

Some popular software packages for sample size calculations have made it relatively straightforward to incorporate futility guidelines into a group sequential design (GSD). These packages offer a variety of methods for determining futility, the most popular options being spending functions and conditional power. Designs with futility can be derived quickly and with relatively little thought, which can present serious problems. At times this results in studies with horrendous operating characteristics when it comes to the probability of study termination under the alternative hypothesis. In other words, a study may be terminated prematurely even if there is some likelihood that under the alternative hypothesis that it could meet its primary objective. Our goal is to evaluate the strategies for futility in GSDs and provide a guide as to which strategy to use, and so we propose various metrics, including ones derived from concepts in diagnostic testing, and give guidelines for their use. We give an example where we assess common futility strategies for a GSD with a survival endpoint. Examples are also given for two common adaptive strategies for single arm Phase 2 oncology studies.

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

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