FDA and NIH Fail to Enforce Clinical Trial Results Reporting Rules

A Science investigation showed that, while the U.S. government requires companies, universities, and other institutions that conduct clinical trials to record results in a federal database, many fail to comply. In addition, federal officials do little to enforce the law.

In 2017, the FDA and the National Institutes of Health (NIH) clarified expectations for disclosing clinical trial results and penalties for failure to do so in a final rule. Science examined 4,768 trials with results that should have been reported on ClinicalTrials.gov under this rule, which went into full effect on January 18, 2018. While most large pharmaceutical companies’ and some universities’ reporting rates have improved, many other clinical trial sponsors – including the NIH itself – did not. Sponsors violated the law more than half (55%) of the time.

As of September 25, 2019, 30 of 184 sponsor organizations never met a single deadline. These companies, universities, and medical centers failed to report any results for 67% of their trials and missed their reporting deadlines by an average of 268 days.

Despite this lack of compliance, the FDA and NIH have not enforced the aggressive penalties promised in the 2017 statement, including fines of up to $12,103 per day for failing to report trial results.

Deborah Zarin, MD, a physician at Brigham and Women’s Hospital and former head of ClinicalTrials.gov, said that the problem persists because “reporting [results] is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative. Human nature being what it is, people follow the requirements when forced to do so.”

The NIH has been “trying to change the culture of how clinical trial results are reported and disseminated; not so much on the ‘aha, we caught you,’ as much as getting people to understand the value, and making it as easy as possible to share and disseminate results,” according to Lyric Jorgenson, PhD, the agency’s deputy director for science policy.

Patrick McNeilly, PhD, an FDA official who handles trial enforcement matters, said the “FDA has limited resources, and we encourage voluntary compliance.”

Source: STAT, January 14, 2020.