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Activity Number:
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323
- Adaptive Enrichment Designs in Clinical Trials
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 9, 2022 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322518
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Title:
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Overview of Existing Methods for Biomarker-Driven Adaptive Designs
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Author(s):
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Ilya Lipkovich* and Sarah Johnston and Alex Dmitrienko and Daniel Zhao
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Companies:
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Eli Lilly and Company and Bristol-Myers Squibb and Mediana, Inc and University of Oklahoma
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Keywords:
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adaptive clinical trial;
biomarkers;
subgroup identification;
utility function
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Abstract:
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In this presentation, we provide an overview of existing methodologies 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. As an example, we consider randomized controlled clinical trials comparing two treatments in efficacy assessment using a time to event outcome. The efficacy subgroup is to be defined by one or two biomarkers and cut-offs that are unknown to the investigator and must be learned from the data. We present the results of a simulation study comparing operating characteristics of two-stage designs with different subgroup-identification methods applied at the first stage.
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Authors who are presenting talks have a * after their name.
