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Activity Number:
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62
- Topics in Adaptive Designs: Adaptive-Seamless, Group Sequential and Other Designs
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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 #312974
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Title:
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Adaptive Simon’s Two-Stage Design with or Without Targeting Biomarker Subpopulation
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Author(s):
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Weichao Bao*
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Companies:
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Bayer
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Keywords:
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Adaptive;
Simon;
Biomarker
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Abstract:
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Simon’s two-stage design remains the most commonly used design in single-arm Oncology phase II clinical trials where the main objective is to assess the preliminary response rate of an experimental drug to determine whether further investigation is warranted or not. The development of targeted cancer therapies is made possible with molecular and genetic characterization of biological pathways of cancerous tumors. The challenge of the design is to determine whether the experimental drug only has activity in biomarker positive subjects or in all-comers. With uncertainty of the response rate among biomarker positive subjects or the prevalence of biomarker positive subjects due to limited data, this research explored an adaptive Simon’s two-stage design with or without targeting a biomarker positive subpopulation.
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Authors who are presenting talks have a * after their name.
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