AllTrials urges FDA to fine sponsors for not publishing trial results
February 17th marked 13 months since the FDAAA Final Rule – the amount of time clinical trial sponsors are given to post summary results and adverse event information, as per the Final Rule.
In a letter to the FDA, AllTrials explained that the FDA assured the organization – “publicly and privately” – that the new clarifying rules would help it “censure” sponsors that do not publish trial results.
“As the body responsible for compliance with the FDA Amendments Act 2007, you have the power to sanction those who break this law, including the levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov,” AllTrials wrote.
“There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine,” it continued.
Beginning yesterday, February 19th, AllTrials launched a new tracking tool that will publically flag sponsors and trials that break reporting deadlines.
The tracking tool, FDAAA.TrialsTracker.net, uses ClinicalTrials.gov’s data to identify trials “subject to FDAAA 2007 as they reach 13 months from completion date and flags missing results.”
AllTrials explained in the letter that it will write the FDA weekly with a list of these trials.
“As the list grows each week, the website will show a ranking of the sponsors with the most trials that appear in the data to be in breach of the law,” it said.
The tracker will also display an estimate of the total amount in fines that the FDA could impose.
According to the tracker, as of today, February 20th, the FDA could have collected at least $170,000.
“We know that the FDA takes patient safety seriously and we are sure that you will follow the tracker to act on unreported trials,” the letter concluded. “However, to assist you further we will also write weekly with the list of trials that have breached their reporting requirements and a rolling total of the fines that these should incur.”
