Study Shows that Some Clinical Trial Sponsors are Keeping Results Secret

Many clinical trial sponsors are failing to comply with mandatory reporting requirements, and are breaking the law in the process. That’s according to a recent article published in Science by Charles Piller, who argues that these reporting failures endanger public health, and consequently urges the National Institutes of Health (“NIH”) and the US Food and Drug Administration (“FDA”) to step-up enforcement of the law.

A 2007 law required clinical trial sponsors to report results of many trials in a federal database, accessible to the public at clinicaltrials.gov, so that healthcare providers and patients could determine whether new treatments are safe and effective. However, many sponsors failed to do so. So in 2017, NIH and FDA published a final rule, clarifying the law’s expectations, as well as highlighting penalties for compliance failures. That final rule took effect in January 2018. However, the study results show many sponsors still ignore the reporting requirements, and regulatory authorities do next to nothing to enforce it.

The study reviewed over 4700 clinical trials whose sponsors should have posted results by the reporting deadline, which is one year of completing the trial, and determined that 184 sponsor organizations had at least 5 trials with reporting deadlines prior to September 25, 2019. The results showed that 30 of those organizations “never met a single deadline,” failing to report entirely in 67% of their trials, and, in the instances that they did report, missing the deadline by an average 268 days. The list of these “habitual violators” include Harvard University, Boston Children’s Hospital, University of Minnesota and Baylor College of Medicine. Ironically, even NIH’s own institutes had a poor reporting record, where the top 4 NIH institute sponsors, collectively, reported results late or failed to report entirely in more than 60% of trials.

The news isn’t all bad though, as the study found that some sponsors do make “serious efforts to comply.” For instance, 20 big pharmaceutical companies met all reporting requirements, and some major academic centers are showing improvements. For instance, Memorial Sloan Kettering Cancer Center, Duke University and Johns Hopkins University all complied with the law in nearly all of their trials.

However, these bright spots seem to be the exception more than the rule. FDA has the authority to impose a penalty of up to $12,103 per day for reporting failures, while NIH can cut off grants for offenders. However, to date, neither FDA nor NIH has brought any such enforcement actions, and the FDA now says that it will not do so until it “issues further ‘guidance’ on how it will exercise that power.”

The authors note that many sponsors downplay the need for reporting on clinicaltrails.gov, as the results are published in peer-reviewed publications. Others argue that the FDA has limited funding to enforce the reporting requirements, and instead should encourage voluntary compliance. Given the lack of urgency in the industry and with the regulators, it remains to be seen if NIH and FDA will ever step-up enforcement on these reporting requirements.