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Activity Number:
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248
- Statistical Issues Specific the Therapeutic Areas- 2
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2018 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #329540
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Presentation
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Title:
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Predictive Probability on Interim Analysis of Time-To-Event Endpoints with Delayed Treatment Effects
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Author(s):
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Matt Rosales* and Kentaro Takeda
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Companies:
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Astellas and Astellas Pharma Global Development, Inc.
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Keywords:
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predictive probability;
interim;
delayed effect
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Abstract:
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Predictive probability of success is a statistical tool commonly used in clinical trials to support decision making. This is the probability of success of a trial at the final analysis based on existing data. In Oncology, the primary endpoint for late stage trials is typically a time to event endpoint with an assumption of proportional hazard. In some instances, especially in the immuno-oncology area, this assumption is not being met due to the presumed delayed treatment effect. In this presentation, the concept of predictive probability is being extended to accommodate the delayed treatment effect scenario.
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Authors who are presenting talks have a * after their name.
