HHS Issues Final Rule on ClinicalTrials.gov Requirements

PUBLISHED: Sep 23, 2016

The US Department of Health and Human Services (HHS) has issued a final rule that outlines requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration (FDA)-regulated drug, biological and device products. At the same time, the National Institutes of Health has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

According to HHS, expanding the registration information in ClinicalTrials.gov improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study designs, ultimately advancing the development of clinical interventions

Requirements under the final rule apply to most interventional studies of drug, biological and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. 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.

Important elements of the final rule, which is effective January 18, 2017, include:

  • Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting 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; and
  • Providing a list of potential legal consequences for non-compliance.

Follow the link below to read the final rule.

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