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Abstract:
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In the era of precision medicine, biomarkers play an important role in personalized medicine to determine strategies for drug evaluation and treatment selection. Adaptive enrichment designs have been proposed with interim decision rules to select a biomarker-defined subpopulation to optimize study performance. In this session, I will review innovative trial designs proposed to include biomarker hypothesis testing that may require a companion diagnostic device. These include platform, basket, umbrella trials for learning phase trials, various statistical testing strategies in biomarker stratified designs and adaptive biomarker designs for confirmatory trials. I will discuss the statistical challenge of application of biomarker subgroup selection in trial design perspective and how to optimize design to support the clinical trial to maximize the overall probability of success.
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