Former FDA Commissioners Suggest Ways to Expand Use of Real-World Evidence

Three former FDA commissioners unveiled a report that proposes a dozen ways to expand the use of real-world evidence (RWE) and real-world data (RWD).

The commissioners, on behalf of the Bipartisan Policy Center, urged the FDA to issue guidance on how sponsors can use RWE for new indications for existing drugs and support postapproval requirements.

“Real-world data and evidence are also necessary for the implementation of many novel development and approval pathways,” says the report, which was endorsed by Robert Califf, Mark McClellan and Andrew von Eschenbach. As medicine becomes more personalized, they said, “randomized controlled trials will become increasingly less feasible.”