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Activity Number:
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343
- Innovative Trial Designs and Analytics
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Type:
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Contributed
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Date/Time:
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Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304363
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Presentation
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Title:
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Optimal Two-Stage Designs for Exploratory Basket Trials
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Author(s):
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Heng Zhou* and Fang Liu and Cai (Iris) Wu and Cong Chen
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Companies:
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Merck & Co., Inc and Merck and Merck & Co., Inc and Merck & Co., Inc
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Keywords:
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Efficacy Screening;
Immunotherapy;
Master protocol;
Trial optimization
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Abstract:
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The primary goal of an exploratory oncology clinical trial is to identify an effective drug for further development. To account for tumor indication selection error, multiple tumor indications are often selected for simultaneous testing in a basket trial. In this article, we propose optimal and minimax two-stage basket trial designs for exploratory clinical trials. Inactive tumor indications are pruned in stage 1 and the active tumor indications are pooled at end of stage 2 to assess overall effectiveness of the test drug. The proposed designs explicitly control the type I and type II error rates, and can be viewed as a natural extension of Simon’s optimal and minimax two-stage designs for single arm trials to multi-arm basket trials. A simulation study shows that the proposed design method can yield favorable operating characteristics compared with other commonly used design methods for exploratory basket trials.
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Authors who are presenting talks have a * after their name.
