AllTrials urges FDA to fine sponsors for missing trial results

21st February 2018 (Last Updated February 21st, 2018 00:00)

AllTrials has called upon the US Food and Drug Administration (FDA) to impose fines up to $10,000 a day against clinical trial sponsors that fail to publish trial results on ClinicalTrials.gov.

AllTrials has called upon the US Food and Drug Administration (FDA) to impose fines up to $10,000 a day against clinical trial sponsors that fail to publish trial results on ClinicalTrials.gov.

The call was made through an open letter written by Ben Goldacre and Síle Lane on behalf of AllTrials to FDA commissioner Dr Scott Gottlieb.

Goldacre and Síle Lane wrote in the letter: “As the body responsible for compliance with the FDA Amendments Act 2007, you have the power to sanction those who break this law.”

According to AllTrials, FDA has not issued a single fine to the trials whose results are pending for years.

They further added: “Since 2014, AllTrials has been asking the FDA to censure these sponsors.

“The FDA has assured us, publicly and privately, that new clarifying rules, the FDAAA Final Rule, will help you do so.

"Relevant trials have 13 months from completion (12 + 1 for quality check) to post summary results and adverse event information."

“Relevant trials have 13 months from completion (12 + 1 for quality check) to post summary results and adverse event information.”

In order to help identify missing trial results, AllTrials has launched a new tracking tool to publicly flag sponsors and trials that violate their reporting deadline.

The tool became live on Monday and will list the trials, which are subject to FDAAA 2007and crossed their specified deadlines for publishing results, using ClinicalTrials.gov’s data.

A ranking of the sponsors will also be highlighted on the tool with the most trials that appear in the data to be in violation of the law.

The tool will also display an estimate of the total amount of fines that the FDA could impose on violators.