The U.S. Department of Health and Human Services and the FDA today released a final rule on results-reporting requirements for ClinicalTrials.gov, expanding registration requirements and providing a defined timeline with requirements for reporting trial results.
The new rule provides clarity on statutory language, laying out objective, structure criteria for evaluating whether studies are “applicable clinical trials.”
The rule clarifies that multigroup and single-group interventional studies with “prespecified outcome measures” are considered “controlled,” and creates a distinction between “secondary” and other pre-specified outcome measures, according to a New England Journal of Medicine report.
The HHS and the FDA laid out rules that expanded transparency beyond the basic statutory requirements in the new rule, now requiring submission of result information for ACTs of unapproved products and submission of baseline information on race or ethnic groups, or other characteristics, associated with primary outcome measures.
Included in the rule are defined required levels of specifications for outcome measures, requirements that responsible parties submit information on adverse-event timeframes and collection methods and all-cause mortality and submission of full protocol and statistical analysis.
With the new rules, the NIH will post submitted records within a specified time frame, “even if the records do not meet quality-control criteria,” including a disclaimer and possible notation of the identified concerns. The NIH will also post registration information for trials of unapproved devices if authorized by a responsible party.
The HHS declined requiring submission of narrative summaries with the rule.
The groups said that the ClinicalTrials.gov data-entry system will be “ready to support all regulatory submission requirements by the rule’s effective date on January 18, 2017.” Groups using the system will have an additional 90 days after the launch to “come into compliance with the final rule,” according to the NEJM report.
