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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 Real-World Evidence in Regulatory Decision-Making for Medical Products: How We Get There from Here (300944)

*Mark Levenson, FDA/CDER 

Keywords: real world, framework, evidence

Recently, the FDA and industry have initiated numerous efforts to leverage rich data sources from routine medical practice to address the benefits, risks, and usage of medical products. These efforts can be considered the big data revolution for evaluating medical products. The use of these data sources (real-world data) and the evidence derived from them should meet the established rigor and standards required for regulatory decisions. A working group of the ASA Biopharmaceutical Section was established to review the issues related to real-world data and provide best practices from a statistical perspective. This talk will review the current state of real-world data and evidence for medical products and introduce the goals and organization of the working group.