Researchers who fail to file trial data with ClinicalTrials.gov on time could be fined up to $10,000 per violation—and the FDA says it will aggressively pursue those penalties.
The agency in new draft guidance says it will determine fine amounts based on the extent, circumstances, nature and seriousness of each violation as well as a sponsor’s prior history and ability to pay—and will tack on additional fines of up to $10,000 each day violations aren’t fixed past the 30-day mark.
Top priority will be given to cases involving repeat offenders, researchers testing higher risk drugs or devices and sponsors whose noncompliance is part of broader noncompliance within a trial.
“The FDA is responsible for enforcing the clinical trial registration and summary results information submission and certification requirements,” FDA Commissioner Scott Gottlieb said in a statement accompanying last week’s draft guidance. “The reliable exchange of this information plays an important role in advancing innovation.”
The agency will identify violations through evidence collected in routine Bioresearch Monitoring Program (BIMO) inspections as well as from outside complaint investigations.
Sponsors will have the option to request a hearing once the FDA files a complaint.
The draft guidance indicates the FDA means business—and will take action if sponsors don’t comply with the regulations. But it also suggests the agency hopes the threat of fines will be enough to prompt researchers to play by the rules – or shape up.
According to the guidance, the FDA “generally intends” to send warning letters (formally called Preliminary Notice of Noncompliance Letters) that will give wayward researchers 30 days to straighten up and fly right before pursuing civil fines.
But the agency says it will also use “a risk-based” approach when evaluating violations of filing requirements. Trials involving drugs, treatments or devices with higher risks to patient health are more likely to attract the FDA’s gimlet eye, as are serial offenders or researchers who are racking up other kinds of violations, the draft guidance states.
The National Institutes of Health (NIH) adopted regulations in 2016 that require researchers to designate a “responsible party” to register and submit trial summary results to ClinicalTrials.gov.
The regs also require researchers developing new drugs, biologics or devices to certify that all ClinicalTrials.gov requirements—such as informed consent documents, investigational new drug applications, new drug applications, and new clinical protocols—have been met.
Congress passed the Food and Drug Administration Amendments Act in 2007 requiring NIH to fashion rules governing clinical trial reporting. But it took the health agency nearly a decade to finish them. Last week’s draft guidance is the FDA’s attempt to catch up with the law, too.
According to a recent study, nearly half of European Union clinical trials go unreported despite similar requirements, with academic institutions most likely to fail to submit the data (CenterWatch Weekly, Sept. 17).
Read the draft guidance here.