tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.
The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.
The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
Both the HHS rule and the NIH policy will be effective on January 18, 2017.
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.
“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”
About the HHS rule
The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.
Elements of the rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
- Requiring additional types of adverse event information
- Providing a list of potential legal consequences for non-compliance.
About the NIH policy
The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).
The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.
