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Data from: Trial-results reporting and academic medical centers.

Citation

Zarin, Deborah A.; Tse, Tony; Ross, Joseph S. (2015), Data from: Trial-results reporting and academic medical centers., Dryad, Dataset, https://doi.org/10.5061/dryad.kv462

Abstract

To the Editor: Reporting of aggregate results helps mitigate disclosure biases affecting medical research. Although the reporting of summary results is currently mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA), published findings suggest underreporting. Two recent proposals are aimed at improving public reporting of aggregate results. These are a Notice of Proposed Rulemaking (NPRM) to expand FDAAA requirements to include the results of trials of unapproved products, and a draft policy requiring the results of all National Institutes of Health (NIH)-funded trials, including those not subject to the FDAAA.

Usage Notes

Location

United States