Clinical trial sponsors who fail to report study results on time to clinicaltrials.gov are now put under public scrutiny, thanks to a new online tracker devised by clinical trial transparency advocacy project AllTrials.
AllTrials unveiled the tool, FDAAA.TrialsTracker.net, through an open letter addressed to FDA Commissioner Scott Gottlieb, M.D. Apparently, it isn’t just designed to name and shame noncompliant trial sponsors, but also to pressure the regulatory body to take actions against them.
To make information about clinical trials more widely available to the public, the HHS issued 42 CFR Part 11 under the FDA Amendments Act 2007 in September 2016. Known as the “Final Rule,” it specifies that all studies regulated by the FDA beyond phase 1 must submit results to the NIH-run clinicaltrials.gov within one year of the primary completion date, and that results will be posted within 30 days after a quality control review process.
Feb. 17 marked the 13 months since the Final Rule came into effect Jan. 18, 2017.
The new tool tracks data from clinicaltrial.gov and identifies those studies that have missed the deadline. Between Monday when the site went live and Wednesday, 12 out of 117 qualified trials failed to show results, according to the website. Columbia University and Imperial College London are among the first batches of sponsors named.
A study published on the BMJ in 2012 found that only 22% of trials that would have been covered by the FDAAA actually had reported results within one year of completion. A 2015 study on the New England Journal of Medicine found that only 13% of trials made it within that time frame.
As AllTrials pointed out in its open letter, the FDA has the power to fine violators up to $10,000 a day. “There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine,” AllTrials wrote.
When asked why no fine has been issued so far, Lauren Smith Dyer, an FDA spokeswoman, explained that it is often not possible to determine noncompliance based solely on the information publicly posted on clinicaltrials.gov. Therefore, she said the agency will assess each one on a case-by-case basis.
The FDA has incorporated the clinicaltrials.gov enforcement activities into its existing Bioresearch Monitoring (BIMO) program, according to Dyer. But the agency might feel more pressure to assess penalties, as AllTrial’s new site also displays an estimate of the total fines it could have imposed. As of Feb. 21, the U.S. government could have collected $290,000 in fines, the tracker showed.
Initiated from the U.K., the AllTrials campaign has a large support group, including over 92,000 individuals and nearly 1,000 organizations such as GlaxoSmithKline and the American Medical Association.