Proposed rules will vastly expand trove of clinical trial data reported in U.S. database

November 19, 2014 7:56 PM

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Proposed rules will vastly expand trove of clinical trial data reported in U.S. database

The amount of clinical data that drug companies must share with the public could soon vastly expand under a U.S. regulation proposed today. Trial sponsors would need to report summary results for drugs and devices that are never approved—and not just for products that reach the market—under the proposal.

The goal of the plan, released by the U.S. Department of Health and Human Services (HHS), is to ensure that summary results for drugs that fail in trials, or are dropped for other reasons, still make it into a public database: ClinicalTrials.gov. Sharing these results should not only be useful for r...

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