A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results.

The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on clinical trials of as yet unapproved drugs that were registered onto the US register ClinicalTrials.gov between 2007 and 2017. This is the ten year period between the introduction of the US clinical trial law, the FDA Amendment Act, in 2007 and 2017 when that law was added to and clarified. Many of the trials under question never reported results. The companies and universities responsible for these unreported trials perhaps did not realize that the FDA Amendment Act applied to them; the law has been widely interpreted as applying to trials of approved drugs only. This judgment has confirmed that this interpretation was wrong and that the Food and Drug Administration, the NIH and the Department of Health and Human Services had been wrong to interpret like this. It is clear now that the 2007 law does and did apply to trials of as yet unapproved medicines as well.

The judgement means that hundreds of clinical trials will now need to report results or continue to be in breach of the law. The FDA Amendment Act mandates that applicable trials are registered onto ClinicalTrials.gov at the beginning of the trial and report results there within a year of the trial’s end. The US Food and Drug Administration has the power to fine the organisations responsible for non-compliant trials more than $10,000 a day for every day they are overdue reporting results. If the FDA decided to apply the same level of fines to trials dating form 2007, that would results in quite large fines. However, there is no indication that the FDA plans to do that. So far it has not declared what action it expects the noncompliant researchers to take not the timeline for compliance. The FDA has the option of appealing this judgment.

Síle Lane, AllTrials and Sense about Science said, “There should be no doubt in researchers’ minds that they urgently need to find ways to get missing results reported. If they haven’t already, they will soon be asked why they haven’t either by authorities like the FDA, by their research funders or by patients who took part in the trials. Researchers looking to get results uploaded might find our guide to uploading results to ClinicalTrials.gov useful.”

The guide can be found here https://www.alltrials.net/ask-your-institution/