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Activity Number:
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318
- Adaptive (and Other) Clinical Trial Designs
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Type:
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Contributed
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Date/Time:
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Wednesday, August 11, 2021 : 3:30 PM to 5:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317996
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Title:
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Bayesian Optimal Phase II Design for Basket Trials
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Author(s):
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Heng Zhou* and Tian He
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Companies:
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Merck & Co., Inc and Indiana University
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Keywords:
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Basket trials;
Bayesian hierarchical model;
Adaptive design
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Abstract:
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We propose a Bayesian optimal phase II (BOP2) design for basket trials. The proposed design uses the calibrated Bayesian hierarchical model to estimate the objective response rate of each indication with information borrowing. At each interim, the go/no-go decision for each indication is made by comparing the posterior probability of the event of interest with an adaptive probability cutoff. The design parameters are optimized by maximizing the power while controlling the family-wise error rate at a desirable level. Numerical studies have shown the proposed design can achieve favorable operating characteristics compared with other Bayesian basket trial designs. The proposed design is a critical addition to the BOP2 framework which can be implemented in many scenarios of phase II clinical trials.
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Authors who are presenting talks have a * after their name.
