Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings.
Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss FDA’s framework for using RWE, which was unveiled in December 2018. The framework is meant to guide FDA on evaluating the potential use of RWE to support changes to labeling, including adding or modifying an indication or adding comparative effectiveness or safety information.
“Transparency on study design and analysis before execution is critical for ensuring confidence in the result,” Corrigan-Curay said, noting that RWE may be able to detect long-term but infrequent outcomes.
More recently, FDA issued draft guidance on the types of RWD and RWE information that might be submitted. Corrigan-Curay also offered several examples of when RWE has informed effectiveness determinations…