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Adaptive enrichment designs for confirmatory trials
Author(s) -
Lai Tze Leung,
Lavori Philip W.,
Tsang Ka Wai
Publication year - 2018
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.7946
Subject(s) - computer science , confirmatory factor analysis , econometrics , adaptive design , statistics , clinical trial , medicine , mathematics , structural equation modeling , machine learning
After an overview of the Food and Drugs Administration's 2012 draft guidance on enrichment strategies for clinical trials to support drug/biologic approval, we describe subsequent advances in adaptive enrichment designs in this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 D iffusion and Perfusion Imaging E valuation f or U nderstanding S troke E volution 3 trial comparing a new endovascular treatment with standard of care for ischemic stroke patients.