News & Press: General News

NIH/FDA Data-Sharing From Clinical Trials

Friday, September 23, 2016   (0 Comments)
Posted by: Whitney Lingafelter
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Dear NIAMS Coalition colleagues:

Today, the U.S. Department of Health and Human Services (HHS) took a major step to increase data sharing and enhance stewardship for clinical trials. HHS issued a final rule for registering and reporting summary results information for certain clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biological and device products to ClinicalTrials.gov.

Additionally, the National Institutes of Health (NIH) issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. Please read more about these important policy developments in the NIH news release and related materials, including articles in JAMA and New England Journal of Medicine.

All researchers conducting clinical trials as described above will be subject to these changes. Please share this information with interested colleagues and members. Attached is a suggested “drop-in” article for your publication or for an email to your membership to communicate these changes.  We hope you find these materials useful and appreciate any effort you can make to help get this important information out to your community.