Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies: A discussion with examples
Heng Li, FDA/CDRH/OSB Nelson T Lu, FDA/CDRH Vandana Mukhi, FDA/CDRH/OSB *Yunling Xu, FDA/CDRH Lilly Q Yue, FDA/CDRH Keywords: medical devices, Nonrandomized studies, Propensity score design Nonrandomized comparative studies have been playing an important role in the premarket evaluation of medical devices. For such studies, objective study design using propensity score methodology is a core component. In this presentation, good practice of objective propensity score design for nonrandomized comparative studies will be discussed and illustrated with examples in a regulatory setting.
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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