In an unprecedented action, the US Food and Drug Administration is threatening to fine a clinical trial sponsor for failing to publish study results on ClinicalTrials.gov.
Federal law requires clinical trial investigators to register their studies on the website within 21 days of enrolling the first participant. Sponsors must also submit a summary of the trial results within 1 year of the study’s completion date.
In a statement issued April 28, the FDA says Acceleron Pharma hasn’t complied. The company ended a trial for dalantercept in combination with axitinib in patients with advanced renal cell carcinoma in 2017, making its results 3 years overdue. Last year, the agency sent Acceleron a letter warning that it could be fined. The company now has 30 days to comply or will be fined up to $12,316 for each day the violation is not corrected, an FDA spokesperson says.
ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997, which required that the government develop a registry of clinical trial information. But the FDA didn’t finalize guidelines for penalizing offenders until last year.
The agency says it takes its role in enforcing ClinicalTrials.gov reporting requirements “very seriously” and that the website enhances public trust concerning medical research. “When these legal requirements are not met, the FDA has the authority to take enforcement action,” Acting Commissioner Janet Woodcock says in the statement.