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The National Institutes of Health (NIH) is toughening up its clinical trial reporting rules with a new Notice of Proposed Rule Making (NPRM).
For a couple of years now, research ethicists have called for greater transparency in clinical trial data. Certain NIH-funded clinical trials are required to be registered on the ClinicalTrials.gov database, with results published on the site and/or in scientific journals within a year of trial completion. But study after study after study show that data is incomplete and investigators have not kept up with reporting requirements. At the moment, only 15,000 of 178,000 trials registered on the site have reported results, according to the NIH.
Big changes in the NPRM include:
Public comment for the NPRM is open until February 19,2015. If you’re up for the challenge (or facing insomnia), the NPRM can be read here in its hefty 447-page entirety. Look for more coverage of the notice in the January issue of IRB Advisor.