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.