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Activity Number: 342 - Topics in Adaptive-Seamless and Group Sequential Designs
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #307003 Presentation
Title: Developing Innovative Group Sequential Design Trials That Account for the Correlation Between Test Statistics
Author(s): JonDavid Sparks* and Bill Prucka and Brian Millen
Companies: Eli Lilly & Company and Eli Lilly & Company and Eli Lilly & Company
Keywords: Adaptive Design; Multiple Testing; Group Sequential Design; Closed Testing

Group sequential designs (GSD) are a well-established approach to maintain strong control of type 1 error while enabling a trial to stop early for efficacy and/or futility based on interim decision rules. Developing the decision rule framework becomes increasingly difficult as the complexity of the trial’s features and number of key scientific objectives increases (i.e. as the number of treatment arms, interim analyses, subpopulations, and endpoints increase). In this talk, we provide two case examples of proposed pediatric group sequential design trials that extend the work of Urach and Posch (2016) on multi-arm GSDs. One trial accounts for the testing of an overall and subpopulation, and the other trial considers multiple arms and interim analyses. Efficient decision rules and alpha-exhaustive closed testing procedures that utilize the known correlation structure among test statistics are proposed, and therefore increase the power of the design. These trials enable early stopping while maximizing the power of both the elementary and global tests, and thus, increase the likelihood of answering key objectives of the trial while enrolling only the necessary amount of participants.

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

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