The U.S. Department of Health and Human Services (HHS) 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 (NIH).
A major change from current requirements that is proposed in the NPRM 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 has proposed a policy 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.
Please note, the NIH definition of a clinical trial was recently updated. The new definition may impact biobehavioral or other types of clinical research projects currently supported by NINR. According to the new definition, to be classified as a clinical trial, a clinical research project must involve the following three key characteristics:
- Prospective assignment of subjects through a pre-defined process;
- An intervention; and,
- Evaluation of a health-related biomedical or behavioral outcome.
For more information on this new definition, please see: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials.
NINR-supported investigators are encouraged to read the NIH news release along with the NPRM and NIH proposed policy changes. HHS and NIH encourage the scientific community’s feedback during the 90-day comment period.