Two important changes are going into effect on Wednesday, Jan. 18, in order to make information about clinical trials more transparent: the HHS final rule and the NIH policy.
Last fall, the U.S. Department of Health and Human Services issued a final rule, an expansion of the current requirements under the FDA Amendments Act of 2007 (FDAAA). The final rule “clarifies and expands the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov,” according to the NIH. “The final rule is intended to make it clear to sponsors, investigators and the public which trials must be submitted, when they must be submitted and whether compliance has been achieved.”
In striving for transparency, the new requirements under the final rule focus on:
- Expanding the scope of trials that need to register and report results,
- Clarifying which studies are Applicable Clinical Trials (ACT) and need to register and report results under the final rule, and
- Explaining what information must be submitted in the database, with clarity on requirements and enforcement timeline in place, in an effort to increase accountability and compliance within the clinical research enterprise.
You can read a summary of the final rule here from the New England Journal of Medicine.
Additionally, the NIH has issued a complementary policy for registering and submitting results to ClinicalTrials.gov for all NIH-funded trials, whether funded in whole or in part.
The new requirements are effective on Jan. 18. As a reminder, under Partners Policy, for investigator-initiated studies, the principal investigator is responsible for complying with the FDA final rule and the NIH policy.