January 6, 2015
The US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) requesting the expansion of the scope of requirements for registering clinical trials and the submission of summary trial results to ClinicalTrials.gov. While ClinicalTrials.gov contains results from over 179,000 clinical trials, around half of all clinical trials for treatments in the US have never published results and thousands have never been registered. Previous efforts of the US regulatory agencies to make trial result reporting mandatory have been met with resistance. Nature highlights that while FDAA requires that all clinical trial results are reported in ClinicalTrials.gov, this rule is seldom respected. The non-report of clinical trial results of approved drugs carries a fine of USD 10,000 per day, but has never been enforced. The NIH and HHS decision to issue the NPRM follows requests to make the clinical trial process more transparent.