On Friday the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) announced actions that should increase the availability of clinical trial data. This parallels an announcement from the Vice President focusing on clinical trials concerning cancer.
The overall goal of these policies is to make the clinical trial much more effective. The announcements focus on making it easier to use clinicaltrials.gov and similar online resources for accessing and sharing clinical trial data. Under the final rule issued by HHS, more trials involved with FDA-regulated drug, biological and device products will need to provide registration data and results on clinicaltrials.gov. This should also make it easier to find clinical trials that need participants. The rule takes effect on January 18, 2017, and affected parties must comply within 90 days of that date.
The NIH policy applies to all NIH-funded clinical trials, which means that some clinical trials not otherwise covered by the HHS rule will fall under the NIH policy (primarily early stage trials for FDA-regulated drugs, biologics and devices and small device feasibility trials). It also takes effect on January 18, 2017.
Complementing the expansion of registration requirements are new compliance measures. Both the HHS rule and the NIH policy allow for marking the clinical trial as non-compliant on ClincalTrials.gov and for withholding grant funds. The HHS rule allows for monetary penalties, and the NIH policy would allow for non-compliance to be considered in future grant applications.
Additionally, the NIH is working to improve the usability of ClincalTrials.gov and may be using the recently released redesign of trials.cancer.gov. While White House Innovation Fellows assisted with the trials.cancer.gov redesign, NIH intends to work with the 18F group at the General Services Administration to improve the clinical trials website.