Reporting and Publication of Postmarket Clinical Trials for Novel Drugs Approved by the FDA

This cross-sectional study describes methods and timing of dissemination of the results of efficacy and safety trials outlined in postmarketing requirements for novel drugs approved by the US Food and Drug Administration (FDA).

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Publication Details

Journal
JAMA Network Open
Published
2026-07-23
DOI
https://doi.org/10.1001/jamanetworkopen.2026.24832
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
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article

Reporting and Publication of Postmarket Clinical Trials for Novel Drugs Approved by the FDA

Maximilian Siebert, Florence T. Bourgeois, Joshua D. Wallach
JAMA Network Open
Statistical Methods in Clinical Trials
article

Reporting and Publication of Postmarket Clinical Trials for Novel Drugs Approved by the FDA

Maximilian Siebert, Florence T. Bourgeois, Joshua D. Wallach
article en

Abstract

This cross-sectional study describes methods and timing of dissemination of the results of efficacy and safety trials outlined in postmarketing requirements for novel drugs approved by the US Food and Drug Administration (FDA).

JAMA Network OpenVol. 9(7)
Boston Children's Hospital (US), Harvard University (US), Emory University (US)
Openalex Percentile: Top 7%
Statistical Methods in Clinical Trials
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