Adaptive enrichment designs for confirmatory trials
Abstract
After an overview of the Food and Drugs Administration's 2012 draft guidance on enrichment strategies for clinical trials to support drug/biologic approval, we describe subsequent advances in adaptive enrichment designs in this direction. We also provide a concrete application in the enrichment design of the Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution 3 trial comparing a new endovascular treatment with standard...
Paper Details
Title
Adaptive enrichment designs for confirmatory trials
Published Date
Sep 11, 2018
Journal
Volume
38
Issue
4
Pages
613 - 624
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