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Real-World Evidence

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval (JAMA Network Open, 11/09/21)

  • The authors examined the feasibility of using real-world data (RWD) to emulate FDA-required postapproval confirmatory trials for all new drugs that received accelerated approval between 2009 and 2018. They found that none of the 50 FDA-required postapproval confirmatory trials granted accelerated approval during this time period could have been feasibly emulated during the real-world data sources of claims or structured electronic health record data.