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And the Result Is…

The US National Institutes of Health has proposed a new policy to promote the sharing of findings from clinical trials that it funds.

The results of clinical trials are often not disclosed in a timely fashion, if at all, say Francis Collins, the NIH director, and Kathy Hudson, the deputy director for science, outreach, and policy in a blog post. They point to a recent study in PLOS One that found that the results of 30 percent of clinical trials haven't been published in a journal or added to ClinicaTrials.gov even some four years after the completion of the trial.

The new rule they propose will require investigators funded by NIH to register their clinical trial and submit summary results, including adverse event information, to ClinicalTrials.gov. This proposal goes further, they say, than the new Department of Health and Human Services rule that summary data from clinical trials of drugs and devices regulated by the Food and Drug Administration, including failed trials, must be publicly shared.

The NIH proposal, ScienceInsider's Jocelyn Kaiser says, would include drugs and devices that are never approved by FDA.

"It is time to embrace an era in which transparency and responsible data sharing are common values," Collins and Hudson write in an editorial at the Journal of the American Medical Association. "Research participants trust that the data they provide will be used to advance the health of many. It is the responsibility of investigators and funders to guarantee that obligation is fulfilled."

The proposed policy is open for public comments through February 19.

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