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With FDAAA the Train Leaves the Station: Reporting Clinical Trial Results.
"With FDAAA the train leaves the station," says this month's editorial, which discusses the requirements of the 2007 Food and Drug Administration Amendments Act for the reporting of clinical trials results. Effective September 2008, a provision of this US law requires that the enrollment and outcome data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository, generally within a year of the trial's completion, whether the results are published or not. But in making these outcomes available the law poses new questions for medical journals, whose editors must assess how much data can be presented publicly without constituting prior publication.
Image Credit: Image by dbking at flickr.com
Citation: (2008) PLoS Medicine Issue Image | Vol. 5(7) July 2008. PLoS Med 5(7): ev05.i07. https://doi.org/10.1371/image.pmed.v05.i07
Published: July 29, 2008
Copyright: © 2008 dbking at flickr. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
"With FDAAA the train leaves the station," says this month's editorial, which discusses the requirements of the 2007 Food and Drug Administration Amendments Act for the reporting of clinical trials results. Effective September 2008, a provision of this US law requires that the enrollment and outcome data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository, generally within a year of the trial's completion, whether the results are published or not. But in making these outcomes available the law poses new questions for medical journals, whose editors must assess how much data can be presented publicly without constituting prior publication.
Image Credit: Image by dbking at flickr.com