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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311000
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Title:
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A Bayesian Adaptive Phase I/II Clinical Trial Design with Late-Onset Competing Risk Outcomes
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Author(s):
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YIFEI ZHANG* and YONG ZANG
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Companies:
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and INDIANA UNIVERSITY
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Keywords:
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Adaptive design;
Competing risk;
Late-onset;
Phase I/II clinical trial;
Targeted therapy
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Abstract:
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Early-phase dose-finding clinical trials are often subject to the issue of late-onset outcome. In phase I/II clinical trials the issue becomes more intractable because toxicity and efficacy can be competing-risk outcomes, and only the one that happens first is observable. In this paper, we propose a novel Bayesian adaptive phase I/II clinical trial design to address the issue of late-onset competing-risk outcomes. We use the continuation-ratio (CR) method to model the trinomial response outcome and the cause-specific hazard rate method for the competing-risk survival outcome. We treat the late-onset outcome as missing data and develop a Bayesian data augmentation method to impute the missing data from the observation. We also propose a dose-finding algorithm to allocate patients and identify the optimal biological dose (OBD) adaptively during the trial. Simulation studies show that the proposed design yields desirable operating characteristics.
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Authors who are presenting talks have a * after their name.
