March 5, 2018
The FDAAA TrialsTracker, an online tool that charts whether individual sponsors report their study results on ClinicalTrials.gov in compliance with federal laws and regulations, launched Feb. 19. The data transparency project was developed by the University of Oxford’s Evidence-Based Medicine DataLab, and is available to the public.
Updated daily, the online tool also calculates the amounts the federal government could fine for noncompliance — although, to date, this number remains at $0, according to the tracker.
“In the absence of formal sanctions from the FDA and others, we argue tools such as ours — providing live data on trial reporting — can improve accountability and performance,” the developers wrote in a prepublished paper outlining the methods and results of the tracker.
“In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported,” they wrote. Sponsors can immediately improve their ratings by reporting their results, as opposed to more static, academic publications on clinical trial transparency.
To date, 116 of 131 trials have reported their results, amounting to 88.5 percent in compliance. According to the tracker, the U.S. government could levy fines against the 15 overdue sponsors totaling just north of $1.2 million. The database also allows a search of more than 15,000 currently ongoing clinical trials.
The ClinicalTrials.gov reporting requirements began with 2007’s FDA Amendment Act, and were later expanded by an NIH final rule that came into effect in January 2017, encompassing 42 CFR Part 11. Although sponsors are required to disclose results for applicable clinical trials within one year of their primary completion date — regardless of the product’s approval status — legal deadlines have begun to pass unfulfilled, as of January of this year.
Applicable trials include interventional studies of FDA-regulated products outside of Phase I or device feasibility testing. The studies include at least one U.S.-based site, initiated after Jan. 18, 2017. The FDA may fine sponsors up to $10,000 for each day results are not submitted past the deadline.
The tracker lists a study as due to report results after one year plus 30 days, to allow for reasonable delays in processing by ClinicalTrials.gov. The 30 days also represents the timeline for notification of missing results before being fined, the developers wrote. In addition to the FDAAA tracker, Oxford’s EBM DataLab has built an automated platform to monitor European Union reporting compliance, which is currently undergoing peer review.
The tracker is available here: fdaaa.trialstracker.net/.
—by Conor Hale @conorhale