The National Institutes of Health (NIH) and U.S. Department of Health and Human Services (HHS) recently proposed new measures to make federally funded clinical trial data more transparent and accessible. For its part, HHS issued a Notice of Proposed Rulemaking (NPRM) that could lead to new reporting requirements for clinical trials that fall under Title VIII of the U.S. 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,” according to a press release.
One major change from current requirements is an expanded scope of clinical trials that would be required to submit summary results to include trials of unapproved, unlicensed, and uncleared products going forward. "This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices, and biological products available to the public," said FDA Commissioner Margaret A. Hamburg, MD, in a prepared statement. "It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products."
ClinicalTrials.gov is home to registration details for more than 178,000 clinical trials, as well as summary information for more than 15,000 trials, including research that does not fall under FDAAA. Registering and reporting clinical trial results helps researchers avoid duplication of previous efforts, and it builds a sense of trust with trial participants.
Separately from HHS, NIH issued a draft policy that would extend the requirement to report summary data to all interventional clinical trials that it funds.
"Medical advances would not be possible without participants in clinical trials," said NIH Director Francis S. Collins, MD, PhD, in a prepared statement. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld."
The comment period for both HHS’s NPRM and NIH’s draft policy is open until February 19, 2015.
Read a summary of both agencies’ proposed changes online.