NIH Director Collins Put in Charge of Recommendations for Improving ClinicalTrials.gov

Before resigning last week, HHS Secretary Sylvia Burwell transferred authority for reviewing recommendations to improve the national clinical trials registry to the director of the National Institutes of Health.

The 21st Century Cures Act, passed last December, requires the FDA, NIH, the Office of the National Coordinator for Health Information Technology and other relevant federal agencies, as well as private industry representatives and the public, to gather ideas for updating the ClinicalTrials.gov database, to improve its usability, functionality and search capability.

The Cures Act requires Collins to begin the consultation process before the end of March. At the same time, the secretary delegated to Collins the task of forming a task force on research specific to pregnant or lactating women, also required by the act.

Last September, HHS issued a final rule expanding the mandate that investigators publically publish their clinical trial results on the government’s website, backing it with strong consequences for non-compliance, including fines. The rule took effect Jan. 18, and requires compliance within 90 days.