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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
Abstract #322616 View Presentation
Title: Designing Multi-Stage Clinical Trials with Multiple Event-Time Endpoints
Author(s): Toshimitsu Hamasaki* and Scott Evans and Tomoyuki Sugimoto and Koko Asakura
Companies: National Cerebral and Cardiovascular Center and Harvard University and Kagoshima University and National Cerebral and Cardiovascular Center
Keywords: Bivariate time-to-event outcomes ; Multiple co-primary endpoints ; Multiple primary endpoints ; alpha error allocation ; Type I error adjustment ; Type II error adjustment
Abstract:

Group-sequential designs are frequently implemented in clinical trials. Some disease areas e.g., oncology or cardiovascular disease commonly utilize event-time outcomes with interim analyses performed when a certain number of events have been observed. In some trials there may be interest in multiple event-time outcomes with evaluation of whether a test intervention is superior to a control intervention on at least one of the event-time outcomes (multiple primary endpoints) or on all outcomes (multiple co-primary endpoints). It is challenging to monitor multiple event-time outcomes in a group-sequential setting as the information fraction for the outcomes may differ at any point in time. We discuss logrank test-based methods for monitoring two event-time outcomes in group-sequential trials that compare two interventions using two time-to-event outcomes. We evaluate two situations: (i) both events are non-composite but one event is fatal, and (ii) one event is composite but the other is fatal and non-composite. We consider several testing strategies for multiple primary endpoints and multiple co-primary endpoints


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

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