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Activity Number: 525 - Translating Real-World Data into Real-World Evidence for Regulatory Decisions and Medical Practice: Opportunities and Challenges
Type: Invited
Date/Time: Thursday, August 6, 2020 : 1:00 PM to 2:50 PM
Sponsor: Biopharmaceutical Section
Abstract #309241
Title: The Biostatistical Landscape of Regulations, Data Sources, Study Variables, and Estimands for Real-World Evidence
Author(s): Mark Steven Levenson*
Companies: FDA/CDER
Keywords: regulatory; medical products; novel data; causal methods

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. Having reviewed the landscape of statistical methods, the workgroup is focusing on several areas in which further development promises to advance the rigorous use of real-world data, including causal frameworks, computable phenotypes, and complex exposure patterns.

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

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