Scrutiny for Sponsors
There are consequences when clinical trial sponsors fail to report study results on time to clinicaltrials.gov. A new online tracker developed by the clinical trial transparency advocacy project AllTrials publicly shames these sponsors by putting them under public scrutiny, reported Angus Liu in Fierce Biotech.
The tool, FDAAA.TrialsTracker.net, was revealed by AllTrials through an open letter addressed to FDA Commissioner Scott Gottlieb, M.D. In addition to its ability to “name and shame noncompliant trial sponsors,” it can “pressure the regulatory body to take actions against them.” The trial tracking tool tracks data from clinicaltrial.gov and names the studies that have missed the deadline. In its first two days, the tracker showed that 12 out of 117 qualified trials failed to show results. Among the first of the sponsors to be cited are Columbia University and Imperial College London.
The reporting problem has been an issue for a long time, according to its proponents. According to a study published in the BMJ in 2012, only 22 percent of trials that would have been covered by the FDAAA “actually had reported results within one year of completion.” According to a 2015 study in the New England Journal of Medicine, only 13 percent of trials did the reporting within that time frame.
In order to make information about clinical trials more widely accessible to the public, the Department of Health and Human Services (HHS) issued 42 CFR Part 11 under the FDA Amendments Act 2007 in September 2016. The “Final Rule” states 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.” The Final Rule has been in effect for 13 months.
AllTrials explained in an open letter that the FDA has the power to fine violators as much as to $10,000 a day for noncompliance. “There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine,” AllTrials said.
To answer the question of why no fine has been imposed thus far, Lauren Smith Dyer, an FDA spokeswoman, explained that it can be difficult to determine noncompliance “based solely on the information publicly posted on clinicaltrials.gov.” The solution, according to Dyer is for the agency to “assess each one on a case-by-case basis.”
While the FDA has integrated the clinicaltrials.gov enforcement activities into its existing Bioresearch Monitoring (BIMO) program, it may feel more pressure to assess penalties. AllTrial’s site provides an estimate of the total fines it could have imposed. As of February 21, the U.S. government could have levied $290,000 in fines, according to the tracker.
The AllTrials campaign, which was initiated in the U.K., has a large support group. Included are more than 92,000 individuals and nearly 1,000 organizations, such as GlaxoSmithKline and the American Medical Association.
Fierce Pharma reported that two companies, Johnson & Johnson and Sanofi, received perfect scores of 100% for clinical trial transparency on the second annual Good Pharma Scorecard. AbbVie, Celgene, Merck and AstraZeneca also achieved a score that was at or above the median of 91% in Bioethics International's study, which ranks new drugs and the companies that make them. J&J was at the top with a 100% transparency rate for the second year in a row.