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Health Agencies Update
January 27, 2015

Proposal Seeks to Enhance Availability of Clinical Trial Results

JAMA. 2015;313(4):346. doi:10.1001/jama.2014.18426

A recent proposal by the Department of Health and Human Services and the National Institutes of Health (NIH) aims to improve public access to clinical trial information.

The proposal describes planned regulations for registering and submitting summary results to ClinicalTrials.gov in compliance with Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires more types of trials to be registered and additional trial registration information to be submitted. A draft NIH policy would also extend similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA.

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