Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL29: Opportunities and Challenges of Using Real-World Data for Regulatory Decision-Making (300830)

*Changming (Sherman) Xia, FDA 

Keywords: real world data, regulatory decision making, combining real world data with clinical trial data, validation of real world data

Room: Wilson B

I plan to lead and engage participants in the following topics: (1) What is the definition and source of real world data (randomized pragmatic trials, claims databases, electronic health record, mobile devices/fitness trackers, etc.)? (2) What are some pros and cons of real world data compared to data from randomized clinical trials? What are some challenges in the data collection and analysis of real world data? (3) How can we use real world data to support regulatory decision making? Can real world data replace data from randomized clinical trials? Or should we use both and combine the data? How do we validate the results derived from real world data?

Participants will be encouraged to share their past/existing experiences of using real world data in clinical development, submission (from industry perspective) and review (from regulatory perspective).