Written by: Jennifer Prozonic

Office for Clinical Research 

Changes and Impact of FDA Final Rule & NIH Policy for ClinicalTrials.gov

In September of 2016, the U.S. Department of Health and Human Services issued a final rule expanding the scope of ClinicalTrials.gov and requiring additional registration and results reporting requirements to the existing Food and Drug Administration (FDA) regulations. The final rule applies to U.S. FDA-regulated drug, biological and device products.

Further expanding the scope of ClinicalTrials.gov, the National Institutes of Health (NIH) also issued a complementary policy to the FDA final rule establishing registration and results reporting requirements for all NIH-funded (wholly or partially) clinical trials, including social and behavioral clinical research, some of which are not currently subject to the FDA final rule.

The effective date for both the FDA final rule and the NIH policy is January 18, 2017. Emory’s Office for Clinical Research is currently facilitating ClinicalTrials.gov entry, in conjunction with investigators at Emory, for investigator-initiated, Emory-sponsored clinical trials. Registration requirements dictate registration in ClinicalTrials.gov no later than 21 days after enrollment of the first participant in a clinical trial.

Potential penalties for not adhering to the new policy and final rule include the following:  identification of clinical trial record as non-compliant in ClinicalTrials.gov; judicial remedies for violations include injunctions and criminal penalties by the FDA and the DOJ; civil monetary penalties of up to $10,000/day; may lead to suspension or termination of grant or contract funding and can be considered in future funding decisions.

This joint effort for new requirements in ClinicalTrials.gov seeks to improve the transparency of clinical trials, facilitate recruitment opportunities for patients seeking participation, disseminate information to the public, mitigate publication bias and advance science.

Major Additions to the FDA Final Rule impacting ClinicalTrials.gov include the following:

• Additional data elements are required for registration and results reporting. Some data elements that are currently optional when submitting information will now be required, and some new data elements will also be required.
• The full protocol and statistical analysis plan (if separate from the protocol) will also be required with results reporting.
• Results reporting is required for all applicable clinical trials that are required to register. The deadline for results information submission is no later than one year after final data collection.
• Some data elements must be updated more frequently than the standard 12 months (e.g., 30 days, 15 days).
• Corrections to submitted information will be required within 15 days (for registration information) and 25 days (for results information). 

New ClinicalTrials.gov NIH Policy Requirements require the following:

• The final NIH Policy complements the FDA final rule in that the NIH Policy applies to all clinical trials funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether they are subject to the final rule. The NIH Policy applies to clinical trials which are defined as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
• Applicants for NIH funding are required to submit a plan outlining how they will comply with the clinical trial information dissemination expectations of the policy. A template on behalf of Emory is available on the OCR website under “ClinicalTrials.gov”.

Next Steps

Emory’s Office for Clinical Research will continue to facilitate registration, updates, and results reporting for ClinicalTrials.gov. For questions or more information regarding clinical trial determinations, applicability of the FDA final rule and the NIH policy and general ClinicalTrials.gov requirements, please contact the Office for Clinical Research at OCR@emory.edu or 404-778-4960.