The National Institutes of Health (NIH) is seeking comments on its draft policy “to promote broad and responsible dissemination of information on clinical trials funded by the NIH” through registration and submission of summary results information to ClinicalTrials.gov.
NIH has a number of policies designed to promote the distribution of research results and guide funding recipients in disseminating their results, including the NIH Data Sharing Policy, the NIH Public Access Policy, the NIH Research Tools Policy, and the NIH Genomic Data Sharing Policy. According to the NIH, a recent study found that the results of less than half of NIH-funded clinical trials had been published in a peer-reviewed biomedical journal within 30 months of trial completion. “Selective publication of the results of some trials and not others – or publication of incomplete or partial findings from a particular trial – can lead to inappropriate conclusions about the usefulness of particular therapies.”
Compliance with the new policy will be a term and condition in the Notice of Grant Award and a contract requirement in the Contract Award. When the final policy is issued, NIH will provide more specific procedural guidance.
Comments are due on the draft policy by February 19, 2015. For more information see the notice.