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Activity Number:
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458
- New Challenges in Subgroup Analyses and Enrichment Designs
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323286
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View Presentation
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Title:
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Stochastic Optimization of Adaptive Enrichment Designs for Two Subpopulations
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Author(s):
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Michael Rosenblum and Aaron Fisher and Joshua A Betz* and Jon Steingrimsson
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Companies:
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Johns Hopkins University and Harvard University-Department of Biostatistics and Johns Hopkins University and Johns Hopkins University
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Keywords:
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Clinical Trials ;
Optimization ;
Simulated Annealing ;
Treatment Effect Heterogeneity
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Abstract:
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An adaptive enrichment design is a randomized trial that allows enrollment criteria to be modified at interim analyses, based on a preset decision rule. When there is prior uncertainty regarding treatment effect heterogeneity, these trial designs can provide improved power for detecting treatment effects in subpopulations. We present a simulated annealing approach to search over the space of decision rules and other parameters for an adaptive enrichment design. The goal is to minimize the expected number enrolled or expected duration, while preserving the appropriate power and Type I error rate. We also explore the benefits of parallel computation in the context of this goal.
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Authors who are presenting talks have a * after their name.
