期刊
STATISTICS IN MEDICINE
卷 38, 期 4, 页码 613-624出版社
WILEY
DOI: 10.1002/sim.7946
关键词
adaptive designs; clinical trials; heterogeneity
类别
资金
- National Science Foundation [DMS 1407828]
- National Institutes of Health [1P30 CA124435, 1UL1 RR025744]
After an overview of the Food and Drugs Administration's 2012 draft guidance on enrichment strategies for clinical trials to support drug/biologic approval, we describe subsequent advances in adaptive enrichment designs in this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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