Monday, December 22, 2014

B - Public access to clinical study results

Kaiser J. U.S. to expand public access to clinical study results. Science 2014;346(6213):1043

Two U.S. government proposals could expand the amount of data from clinical trials. A draft regulation from the U.S. Department of Health and Human Services would require companies sponsoring clinical trials to report summary results for drugs and devices that are never approved, not just for those that reach the market. And a proposed policy from the National Institutes of Health (NIH) would expand the requirement—which now applies only to trials regulated by the Food and Drug Administration—to all trials funded by the health agency.
http://news.sciencemag.org/health/2014/11/proposed-rules-will-vastly-expand-trove-clinical-trial-data-reported-u-s-database

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