The new policies are intended to encourage greater participation in clinical trials and to promote dissemination of trial results so patients can more quickly garner the benefits from research findings.
The rule expands and clarifies which trials are required to submit data to ClinicalTrials.gov. Entities that are subject to the rule will have 90 days after its Jan. 18, 2017, implementation date to come into compliance. Among the requirements:
- Clinical trials must be registered within 21 days after the first human subject is enrolled
- Summary results must be submitted within one year of the study’s completion
- Protocols must be posted
- Adverse events must be disclosed
- Race and ethnicity information must be included in results
Although the policies have been under consideration for several years, with publication of a proposed rule in 2014, the final rule aligns with priorities set forth by Vice President Joe Biden as part of the Cancer Moonshot initiative.