Designing Observational Comparative Studies Using Registry Data in Regulatory Settings
Nelson T Lu, FDA/CDRH Yunling Xu, FDA/CDRH *Lilly Q Yue, FDA/CDRH Keywords: Registries, Regulatory decision making, Propensity score design National and international registries, which reflect real world evidence, can play important roles in regulatory decision making in both pre-market and post-market settings. This presentation focuses on developing innovative strategies to utilize such data – prospectively designing clinical studies with propensity score methodology, and examples will be given based on regulatory reviews.
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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