Dive Brief:
- The Department of Health and Human Services issued a final rule Friday specifying requirements for certain types of clinical trials to be registered at ClinicalTrials.gov, in order to make the information available for public knowledge.
- Although requirements for posting trials to the website have existed since 2007, they were previously unclear and often disregarded by universities and corporations, according to NPR.
- The changes include more expansive rules that go into effect in January 2017, as well as a list of "potential legal consequences" for non-compliance.
Dive Insight:
While the NIH notes that it "does not dictate how clinical trials should be designed or conducted, or what data must be collected," the increased public scrutiny of the trials could arguably impact how and what future research is conducted, and thereby the practice of medicine further down the line.
That appears to be exactly what federal officials have in mind.
- A checklist to determine which trials are subject to the regulations and who is responsible for submitting the information;
- The expansion of the scope of trials that must be submitted;
- Requirements for additional data elements including trial participants' race and ethnicity, and the full protocol;
- Expanded requirements on adverse event information; and
- The list of consequences for non-compliance.
According to NPR, some fines under the existing rules can already amount to $10,000 per day for non-compliance, though they have not been imposed -- and there will not be additional funding for FDA enforcement staff. NIH director Francis Collins told NPR researchers could find future funding on the line, as the NIH would consider withholding future funds from non-compliant institutions until they get on board.