Real-World Evidence: What’s in a Name?

• Activity Number: 365 - Causal Integration of Randomized Clinical Trials and Real-World Data: Challenges and Opportunities
• Type: Invited
• Date/Time: Wednesday, August 10, 2022 : 8:30 AM to 10:20 AM
• Sponsor: WNAR
• Author(s): John Concato*
• Companies: Food and Drug Administration

Abstract

Dr. Concato will provide an overview of real-world data (RWD) and real-world evidence (RWE) from an epidemiological perspective, emphasizing the need for clarity in terminology when planning, conducting, and reporting on research involving RWD; his presentation will also include general comments on causal inference from a clinical perspective. FDA’s RWE Program for drug and biological products across the drug development lifecycle will be described, and insights will be provided into FDA approval of drugs and biological products based on “RWE.”