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Activity Number:
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75
- SPEED: Data Challenge and SPAAC
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Type:
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Topic-Contributed
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Date/Time:
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Monday, August 9, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318570
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Title:
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Adaptive Enrichment Design with Multiple Interim Analysis for Clinical Trials with Biomarker
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Author(s):
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Hao Zhang* and David Gold
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Companies:
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Amgen Inc. and Amgen Inc.
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Keywords:
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adaptive design;
enrichment;
biomarker;
group sequential;
optimize;
oncology
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Abstract:
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Many of the modern drugs targets for a specific subset (biomarker positive) of all the patients with the disease. The 2-stage adaptive enrichment design was proposed to adjust the patients to be enrolled during the trial to reduce the unnecessary exposure of patients with no treatment effect while preserving Type-I error and maintaining the power. We extended it with multiple enrichment interims and develop an optimizing method to minimize the trial cost (sample size and duration) at given conditions. We applied our method with assumptions obtained from literature research of advanced solid tumor as a practice and find that on average one to two times of the median survival time can be saved with respect to the decision time of enrichment for a typical Ph2 clinical trial. We furtherly evaluated the operating characteristics of the design under the different efficacy and biomarker scenarios providing the clinical trial research clinicians the flexibility optimizing the trial with their own knowledge of the biomarker and preference. Lastly, we added the group sequential element to bring more flexibility to the design.
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Authors who are presenting talks have a * after their name.
