Real-World Evidence — Where Are We Now?
Correcting misconceptions about RWD and RWE requires recognition that the degree of reliance on RWD varies with the type of study design and that RCTs that incorporate RWD generate RWE, and that even when strict eligibility criteria may limit the generalizability of trial results, trial participants exist, and their outcomes occur, in the “real world”.
Abstract
Interview with Kushal Kadakia on the 21st Century Cures Act, Cures 2.0, and lessons from Covid-19 for medical product development. (11:29)Download Notwithstanding ongoing confusion over the concepts of "real-world data" and "real-world evidence" in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.