All Times EDT
Keywords: Real-world data, real-world evidence
To fulfill its mandate established by the 21st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI), the FDA in December 2018 released the framework for using real-world data (RWD) and Real-World Evidence (RWE) to support research efforts, ranging from retrospective cohort studies to prospective randomized trials in real-world settings. The framework outlines key considerations for evaluating the potential use of RWD and RWE for regulatory decisions related to the effectiveness for marketed products. The framework is guided by a three-part approach: (1) Is the RWD fit for use?; (2) Does the trial or study design used to generate RWE provide adequate scientific evidence to answer or help answer the regulatory question of interest?; and (3) Did the conduct of the study meet FDA regulatory requirements?
In this roundtable, we will discuss the progress made so far on the implementation of the framework. We will explore the current state of RWE in regulatory submissions. We will discuss how academic, industry and regulatory experts can work together to advance the science in this area. Discussion could include examples where pre- and post- marketing data were utilized in RWE to improve and/or accelerate treatment development and patient care.