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Activity Number: 438 - Real-World Evidence in Clinical Trial: New Era of Informed Decision Making Session
Type: Invited
Date/Time: Wednesday, August 2, 2017 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #322005 View Presentation
Title: Statistical Design Considerations for Utilizing Real World Data in Premarket Evaluation of Medical Devices
Author(s): Yunling Xu* and Nelson Lu and Lilly Yue and Ram Tiwari
Companies: CDRH/FDA and CDRH/FDA and Division of Biostatistics, CDRH/ U.S. FDA and FDA/CDRH
Keywords: Real world data ; Premarket ; Statistical design ; Medical device
Abstract:

With the increase in demand for utilizing real world data to reduce the time and cost of bringing a medical device to the market, there are statistical challenges that need to be carefully addressed. "Fit for purpose" is the key in utilizing real world data in premarket evaluation of medical devices. From this perspective, in this talk, potential purposes and corresponding statistical designs will be discussed, emphasizing protection of study validity and integrity for decision making.


Authors who are presenting talks have a * after their name.

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