The U.S. Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.
In addition, NIH proposed a policy today to promote transparency for all NIH-funded clinical trials, whether or not they are subject to FDAAA. The proposed policy expects registration and submission of results information like that required by FDAAA in ClinicalTrials.gov of every clinical trial that receives NIH dollars.
To find out more about the NPRM and the newly revised policy go to http://www.nih.gov/news/health/nov2014/od-19.htm