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FDA’s Next Step to Real-World Evidence: Prove That Real-World Studies Can Match Known RCT Results

 
• By Cole Werble

Industry is eager to develop approval pathways that rely on “real world” evidence from insurance claims and electronic health records. FDA, however, thinks the next step needs to be develop and validate the methodology.

Center for Drug Evaluation & Research Director Janet Woodcock has a suggestion for the next step in advancing the use of “real world” evidence to support product approvals.

“Can we do a retrospective/prospective experiment?” she asked during March 3-4 workshop on real-world evidence in regulatory decision-making convened by the Duke-Margolis Center for Health Policy (replay here

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