FDA Starts Enforcing Clinicaltrial.gov Law
(Thursday, April 29, 2021)
Almost 14 years since the passage of the law requiring that results of clinical trials be posted within a year of trial completion, yesterday, FDA issued the first notice of non-compliance to a sponsor for violating the law, and promised stricter enforcement going forward. Ever since the creation of the clinicaltrials.gov online registry in the year 2000, it has become the world’s leading listing of clinical trials containing descriptions of more than 375,000 trials in 220 countries. By law, all Phase 2 and 3 trials conducted in the US must be registered with clinicaltrials.gov. The registration provision of the law has been quite popular. Almost all clinical trials, even those that do not require registration, are listed on clinicaltrials.gov by sponsors. Since the website is maintained by NIH, listing on clinicaltrials.gov creates a perception of US government support for a clinical trial. To dispel the perception, clinicaltrials.gov now carries a disclaimer that “listing a study does not mean it has been evaluated by the U.S. Federal Government.” However, when it comes to posting results of clinical trials on the website, the record has been far from perfect. Till last year, less than 50% of the clinical trials whose results must be posted, did so. There has been constant public outcry for the lax enforcement of the law with some groups going as far as creating a tally of the violators and the potential monetary penalty FDA could have collected from those perpetrators. After much goading, FDA announced an enforcement policy and released a Guidance document last August warning sponsors who fail to submit results in a timely fashion of monetary penalties. Immediately thereafter FDA sent about 40 pre-notices to sponsors warning of their non-compliance to encourage them to bring their clinicaltrials.gov posts in compliance. Yesterday, one of those sponsors, who was still non-compliant despite the pre-notice, finally received the notice of non-compliance giving it an ultimatum of 30 days to get in compliance or face monetary penalties. FDA also created a new webpage for listing notices of non-compliance. One would expect the violating sponsors to get a strong nudge with this notice, and post results. It would be interesting to see how many more such notices are issued and if FDA must resort to penalties to enforce the law. Public records show that there are still many potential violators of the law, and we can assume that FDA is getting ready for aggressive enforcement. If you are one of those sponsors, this should be the wake-up call you were waiting for to get the results of your clinical trial on clinicaltrials.gov.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC