Posted by Michael Wonder on 21 Aug 2019
Former FDA Commissioners seek to expand use of RWE in regulatory, payment decisions
21 August 2019 - A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world evidence in regulatory and payment decision-making.
The report comes less than a year after the US FDA released its Framework for FDA’s Real-World Evidence Program.
“Real-world evidence generated from the application of appropriate research methods and analysis of data derived from clinical, claims, and patient-facing software and systems can play a significant role in improving and modernising both the drug evaluation and approval process and new value-based payment arrangements in the United States,” the report, authored by former Senate Majority Leader William Frist and former FDA Commissioners Robert Califf, Mark McClellan and Andrew von Eschenbach, says.
