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Summary
Two U.S. government proposals released last week could vastly expand the amount of data from clinical trials that becomes public. 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. The goal is to increase transparency about clinical trials by ensuring that more results make it into ClinicalTrials.gov, a public database run by NIH.
