The U.S. Food & Drug Administration (FDA) has issued a draft guidance statement proposing heavy fines for pharmaceutical companies and clinical research organizations (CROs) that neglect to post clinical trial results online. According to the statement, the FDA wants to fine organizations that fail to register clinical trials or to report results on to the government database ClinicalTrials.gov as much as $10,000 per day.
The FDA would send the appropriate organization a notification letter that warns the company of its alleged infraction. Afterwards, the company would be allowed 30 days to become compliant with the FDA directive before being subject to any fines. According to the guidance statement, the FDA revealed that it had the intention of identifying violations relevant to posting on the online data bank. It would achieve that identification by means of evidence garnered during inspections performed as part of FDA’s Bioresearch Monitoring Program, in addition to complaints that the agency might receive. Pursuant to the guidance statement, the public has 30 days to provide comments to the FDA on the potential ruling.
Recent studies show that approximately 58 percent of industry-funded clinical trials and 61 percent of clinical trials funded by the National Institutes of Health (NIH) in the U.S. did not report their results five years after they were completed. A recent BMJ paper revealed that about half (49 percent) of eligible clinical trials in the EU have not been posted in the European Clinical trial registry. In a 2015 study in the U.S., it was determined that about 20 percent of industry trials had not reported clinical trial results in the timeframe required, and approximately 50 percent of NIH-sponsored research was unreported.
ClinicalTrials.gov began in 2000 after Congress enacted a law that required the NIH to set up a public registry of clinical trials performed to test the efficacy of experimental drugs for patients who had serious or life-threatening diseases or conditions. At the time, the objective was to make it easier for patients to get access to clinical trials that might help them in critical situations. Not long after that, people began to present ethical arguments in support of greater transparency around clinical trials in general. In 2005, the International Council of Medical Journal Editors (ICMJE) started to require anyone who wanted to publish an article in its member journals register clinical trials in a public database before enrolling the initial participant. The objective of the editors was to help alleviate the issues of selective publication when clinical trial outcomes are in conflict with sponsor or investigator interests, selectively using data through unplanned subgroup analyses or changing endpoints or outcome criteria part way through the trial to ensure positive outcomes.
While interest in registering trials at ClinicalTrials.gov appeared to be working, the ICMJE requirement had no influence in changing the behaviors of people who did not care about publishing an article in a prestigious medical journal. Additionally, the did not require public posting of clinical trial results.
In 2007, Congress made it a legal requirement to report the results of certain clinical trials. Still, the government has not monitored the system the way it might, leaving tens of billions of dollars in penalties uncollected and transparency to be questioned.