The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect between the endpoints used by regulators and the information collected in clinical practice, according to panelists at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).
“I wish we could get rid of the term real-world data and real-world evidence,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), said at the CERSI Summit. “We were an early adopter of that at the FDA and it’s become a four-letter word. At the end of the day, we’re talking about clinical evidence.”…
