Activity Number:
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218
- Efficient Designs and Better Decision-Making Strategies in Complex Clinical Trials: Multiple Arms, Multiple Endpoints, and Multiple Stages
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 31, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322616
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View Presentation
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Title:
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Designing Multi-Stage Clinical Trials with Multiple Event-Time Endpoints
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Author(s):
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Toshimitsu Hamasaki* and Scott Evans and Tomoyuki Sugimoto and Koko Asakura
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Companies:
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National Cerebral and Cardiovascular Center and Harvard University and Kagoshima University and National Cerebral and Cardiovascular Center
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Keywords:
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Bivariate time-to-event outcomes ;
Multiple co-primary endpoints ;
Multiple primary endpoints ;
alpha error allocation ;
Type I error adjustment ;
Type II error adjustment
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Abstract:
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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
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Authors who are presenting talks have a * after their name.