A Simple and Flexible Graphical Approach for Adaptive Group-Sequential Clinical Trials

• Activity Number: 218 - Efficient Designs and Better Decision-Making Strategies in Complex Clinical Trials: Multiple Arms, Multiple Endpoints, and Multiple Stages
• Type: Topic Contributed
• Date/Time: Monday, July 31, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Frank Bretz* and Toshifumi Sugitani and Willi Maurer
• Companies: Novartis AG and Astellas and Novartis
• Keywords: Adaptive design ; closed test procedure ; graphical approach ; group-sequential design ; inverse normal combination test ; sample size reassessment

Abstract

We introduce a graphical approach to testing multiple hypotheses in group-sequential clinical trials allowing for midterm design modifications. It is intended for structured study objectives in adaptive and group-sequential designs using the graphical approach to multiple testing. The resulting test strategies can be visualized graphically and performed iteratively. We illustrate the methodology with an example from our clinical trial practice.

Reference: Sugitani T, Bretz F, Maurer W (2016) A simple and flexible graphical approach for adaptive group-sequential clinical trials. Journal of Biopharmaceutical Statistics 26(2), 202-216.