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Activity Number:
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203
- Recent Advances in Bayesian Adaptive Designs, from Early Phase to Confirmatory Trials
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Type:
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Topic-Contributed
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Date/Time:
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Tuesday, August 10, 2021 : 1:30 PM to 3:20 PM
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Sponsor:
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Caucus for Women in Statistics
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Abstract #317416
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Title:
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A Bayesian Phase II Clinical Trial Design for Multinomial Endpoints
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Author(s):
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Rui Qin* and Yalin Zhu
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Companies:
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Janssen Pharmaceuticals and Merck & Co Inc
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Keywords:
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Bayesian design;
phase II ;
clinical trial;
multinomial endpoint
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Abstract:
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An experimental therapy is evaluated as a neoadjuvant therapy for certain resectable skin cancer with high risk feature. Pathological complete response (pCR) after surgery experience early progression of disease (ePD) during neoadjuvant therapy are considered as multiple primary endpoints for a single-arm phase II clinical trials. A Bayesian Phase II design is proposed with adaptive feature for go or no go decision making. Simulation studies are conducted to compare the operating characteristics against the Frequentist multinomial designs.
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Authors who are presenting talks have a * after their name.
