Hidden clinical trial results: FDA threat of fines highly effective, but rarely used

Warning letters from the Food and Drug Administration have been highly successful at bringing unreported clinical trial results to light, a new study shows. However, the FDA is sending out such letters at a glacial pace.


Between 2013 and the end of April 2021, the FDA only sent 57 warning letters to pharma companies and universities that had failed to make their clinical trial results public as required by law, data obtained through Freedom of Information requests show. Meanwhile, thousands of clinical trials are still missing results in violation of the law.


“The FDA has yet to send Pre-Notices (or Notices) to thousands of responsible parties that have not reported results, including government sponsors such as the NIH,” the study authors note.


When the FDA did contact trial sponsors, the letters had a strong impact. Over 90% of the missing trial results in question have by now been made public by the responsible parties.


Under US federal law, clinical trial sponsors face a fine of $10,000 for every day that they fail to make the result of an applicable clinical trial result public. The FDA first sends out a “Pre-Notice of Noncompliance”; 57 of those were sent up to April 2021. If the sponsor still fails to upload the missing result, the FDA follows up with a “Notice of Noncompliance” threatening a fine.


To date, the FDA has only issued three of these final warnings – in each case, the missing trial result was rapidly made public.


The study notes that three trends stand out:


  • “First, the 57 Pre-Notices represent a tiny fraction of the thousands of FDAAA-applicable clinical trials identified as noncompliant with results information reporting requirements as of January 2021.”

  • “Second, the FDA sent no Pre-Notices to any federal agencies, including the NIH, even though the NIH is the responsible party for many trials that have not submitted mandated results to ClinicalTrials.gov. Instead, most Pre-Notices were sent to industry, with a smaller number sent to academia and other organizations.”

  • “Third, Pre-Notices may be effective at improving compliance: as of August 17, 2021, more than 90% of the 57 Pre-Notice recipients had reported missing information to ClinicalTrials.gov. Among recipients who submitted missing results information after receiving a Pre-Notice, the median time for submission was approximately 3 weeks.”


The study was published in JAMA last week.



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