Trial-Results Reporting and Academic Medical Centers
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To the Editor: Reporting of aggregate results helps mitigate disclosure biases affecting medical research.1 Although the reporting of summary results is currently mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA),2 published findings suggest underreporting.3 Two recent proposals are aimed at improving public reporting of aggregate results. These are a Notice of Proposed Rulemaking (NPRM)4 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.5 Noncompliance with either requirement would carry a risk of NIH-funding loss and other finan-
[1] James Topping,et al. Compliance with results reporting at ClinicalTrials.gov. , 2015, The New England journal of medicine.
[2] F. Collins,et al. Sharing and reporting the results of clinical trials. , 2015, JAMA.
[3] Tony Tse,et al. The proposed rule for U.S. clinical trial registration and results submission. , 2015, The New England journal of medicine.
[4] Harlan M Krumholz,et al. Increasing value and reducing waste: addressing inaccessible research , 2014, The Lancet.