Posted by Michael Wonder on 16 Sep 2016
Trial reporting in ClinicalTrials.gov - the final rule
16 September 2016 - The clinical trials registry currently has more than 224,000 study records, 23,000 of which display results information. Compliance with the results-reporting requirements, however, has been low across many sectors of the clinical research enterprise.
Low compliance to be due, in part, to the ambiguity of some statutory requirements. The details provided in the final rule should help increase accountability within the clinical research enterprise: going forward, investigators, sponsors, and the general public will be better able to evaluate what information is required to be submitted and, in general, whether compliance has been achieved.
After issuing a Notice of Proposed Rule-making in November 2014, the US Department of Health and Human Services (HHS) received nearly 900 comments from individuals and organizations, including companies, trade associations, academic institutions, patient advocacy groups, and members of the general public.
After careful consideration of these comments, the HHS has developed the final rule, which was made publicly available on September 16, 2016. Simultaneously, the National Institute of Health (NIH) issued a complementary final policy, under which NIH-funded awardees and investigators will be expected to submit registration and results information for all NIH-funded clinical trials, whether or not the trials are covered by legislative requirements.
