Organisations that fail to report the results of their clinical trials are to be named on a new website set up by the AllTrials campaign group.
The new FDAAA Trials Tracker site went live this week and – as its name suggests – seeks to highlight the failings of the FDA Amendments Act 2007 law which required certain clinical trials to report results on the clinicaltrials.gov website.
A letter from AllTrials campaigners Ben Goldacre and Síle Lane to FDA Commissioner Scott Gottlieb explains the reasons for the new site, noting that while the FDA has the power to fine trial sponsors up to $10,000 per day who fail to publish results “there are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine”.
New FDA clarifying rules – which introduced a 13-month period before summary results and adverse event information must be reported – came into effect on February 17, two days before the Trials Tracker site went live and started “publicly flagging sponsors and trials that breach their reporting deadline”.
As of this week, the tracker’s top line notes that 89.7% of trials (105 of 117) have been reported, which means the US government could have imposed $290,000 in fines on pharma companies and academic institutions who have missed the deadline. So far it hasn’t levied any penalties.
“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,” say Goldacre and Lane in the letter.
Last year, an audit of 42 top manufacturers from the EU, US and Japan by AllTrials found massive variations between companies when it came to registering and reporting the results of clinical trials.
“The results of clinical trials are being routinely withheld from doctors, researchers, and patients,” said Goldacre at the time. It’s a view shared by the US Institute of Medicine, which published a report in 2015 highlighting the issue and concluded that unpublished data is harming research and short-changing patients who volunteer for studies.
“We know that the FDA takes patient safety seriously and we are sure that you will follow the tracker to act on unreported trials,” writes Goldacre and Lane in their letter. “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.”