FDA guidance and regulatory experience on enrichment design
*Yuan Li Shen, FDA/CDER/OTS/OB *Raji Sridhara, FDA/CDER/OTS/OB Keywords: In the era of personalized medicine and targeted therapy, it is important that the drug development process is conducted efficiently. It is therefore essential to adapt during trial based on the interim results observed to stop for futility, efficacy or modify the study by increasing sample size, or focus the remainder of the study on a subpopulation. We will present the FDA guidance on enrichment design and regulatory experience in these type of adaptive designs.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC