Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of medication safety and efficacy, beyond the original clinical trials submitted for FDA approval.

Issues with drug safety and efficacy that may have been missed in the clinical trials phase can be reassessed after a drug goes to market. The FDA has already started to recognize this problem, for example, in the deployment of the FDA Sentinel Initiative, which has developed into a core component of the agency’s evolving safety surveillance system.

Clinical trials submitted to the FDA during the drug approval process, while methodologically rigorous, typically involve controlled settings with limited participant diversity, short follow-up periods, and small sample sizes. Real-world clinical data provide complementary insights by capturing data from broader, more diverse populations in routine clinical practice.

For example, pregnant women, patients with........

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