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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 #312430
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Title:
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Overview of Recent Advances in Biomarker Driven Adaptive Designs
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Author(s):
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Ilya Lipkovich* and Sarah E Johnson and Alex Dmitrienko and Daniel Zhao
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Companies:
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Eli LIlly and Company and University of Oklahoma Health Sciences Center and Mediana, Inc and University of Oklahoma Health Sciences Center
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Keywords:
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Biomarker adaptive design;
Subgroup identification;
Biomarker evaluation ;
Time to event
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Abstract:
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In this presentation, we provide an overview of the state of art methodology for seamless two-stage designs (e.g. Phase 2-3 trial) with a possibility of biomarker-driven selection of a subpopulation based on the results of the first stage. The most promising candidate subgroup is identified using several existing methods for subgroup identification. Based on conditional power evaluated after the first stage, a decision is made whether to terminate the trial for futility, continue the trial without any changes in the overall patient population, adjust the sample size in the same population, or focus on a subpopulation. We present the results of a simulation study that compares biomarker adaptive designs in a study with time to event outcome using different subgroup identification methods (including recursive partitioning and penalized regression) with a standard non-adaptive design in terms of their key operating characteristics under different scenarios.
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Authors who are presenting talks have a * after their name.
