Adaptive enrichment designs for confirmatory trials | Zendy

Lai Tze Leung | Zendy; Lavori Philip W. | Zendy; Tsang Ka Wai | Zendy

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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After an overview of the Food and Drugs Administration's 2012 draft guidance on enrichment strategies for clinical trials to support drug/biologic approval, we describe subsequent advances in adaptive enrichment designs in this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.

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