The National Institutes of Health and the US Department of Health and Human Services want to change how clinical trials researchers report information from their trials, as well as the kind of information they will be required to report.
The agencies have filed a notice of proposed rulemaking to clarify requirements for registering clinical trials and for submitting their trial information to ClinicalTrials.gov., including what they call "a major change" that would expand the scope of clinical trials that would be required to submit summary results. Under their proposal clinical trial results for unapproved and unlicensed products, as well as products that have not been cleared, would have to be submitted to ClinicalTrials.gov.
Also, NIH is proposing a policy that would require all NIH-funded clinical trials to register and submit the same type of information as those trials that are subject to Title VIII of the Food and Drug Administration Act of 2007, even if the clinical trials are not subject to that federal legislation.
"We owe it to every [trial] participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health," NIH Director Francis Collins says in a statement. "This important commitment from researchers to research participants must always be upheld."
The announcement comes on the heels of an article published in JAMA Internal Medicine that found that FDA is hiding clinical trial information from the public, including instances of scientific fraud.