Online Program

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Wednesday, September 25
Wed, Sep 25, 10:45 AM - 12:00 PM
Challenges and Opportunities in the Use of Real-World Evidence in Regulatory Decision-Making of Medical Products: An ASA BIOP RWE SWG Progress

The Use of RWD/RWE to Inform Clinical Trial Design (301025)

*Martin Ho, FDA/CDRH 

The RWD/RWE Informed Clinical Trial Work Stream reviewed the state of the science of how RWD/RWE can inform better clinical trial design. The Work Stream has performed a gap analysis and identified a research agenda with prioritized items. In this presentation, the speaker will first highlight the results of their literature review, followed by a summary of gap analysis. Next, the Work Stream will discuss a research agenda outline. In conclusion, the Work Stream will solicit feedbacks from the statistics community.