After an overview of the Food and Drugs Administration's 2012 draft guidance on enrichment strategies for clinical trials to support drug/biologic approval, we describe subsequent advances in adaptive enrichment designs in this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 of care for ischemic stroke patients.
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| http://dx.doi.org/10.1002/sim.7946 | DOI Listing |
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