Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Most Postapproval Trials Explore Novel Indications

Publish date:: May 23, 2019

Key clinical point: The majority of postapproval clinical trials conducted by pharmaceutical companies explored novel or expanded uses as opposed to monitoring original indications.

Major finding: Among 600 postapproval studies, only 12.0% solely examined the original therapeutic indication.

Study details: A cross-sectional analysis of 37 novel agents without postmarketing requirements.

Disclosures: The study was funded by the Tufts University School of Medicine and the Laura and John Arnold Foundation. The authors reported financial affiliations with Johnson & Johnson, Medtronic, the Blue Cross Blue Shield Association, the National Institutes of Health, the Laura and John Arnold Foundation, and the Food and Drug Administration.

Citation:

Skydel JJ et al. JAMA Netw Open. 2019 May 9. doi: 10.1001/jamanetworkopen.2019.3410

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