Thousands of patients with “lethal” cancer let down by FDA inaction on clinical trials
Thousands of pancreatic cancer patients have participated in clinical trials that never made their results public in violation of U.S. federal law, a study has found.
French researchers reviewed 551 clinical trials involving patients with pancreatic adenocarcinoma and found that 30% had never made their results public in any form. 6,436 patients had participated in those trials.
Trials that did publish results only did so after a median delay of 29 months after trial end.
Widespread legal violations
U.S. legislation requires some (but not all) clinical trials to make their results public on a trial registry within a year of trial completion so that researchers, doctors and patients are able to rapidly access and benefit from new medical discoveries.
However, 92% of the 218 pancreatic adenocarcinoma trials subject to the law had failed to make their results public within the legal one-year deadline.
Over 400,000 deaths a year
According to the research team:
“Not having access to trial results creates an even greater burden for rare and aggressive diseases such as PDAC for which trials can be hard to conduct although new therapeutics are urgently needed.”
“Pancreatic cancer, mostly represented by pancreatic adenocarcinoma, is the 11th most common cancer and the seventh cause of cancer-related deaths worldwide.Its incidence has been rising in the past years, especially in Western countries. Despite the development of various treatments, the prognosis remains very low with a 5-year survival rate of about 10% and approximately 432,242 deaths registered in 2018.”
Till Bruckner, founder of TranspariMED, said:
“Every cancer patient participating in a clinical trial should be able to trust that results will rapidly be made public as required by law – but this is clearly not the case. The Food and Drug Administration’s long-standing failure to enforce the law harms patients, full stop.”
Promises made, promises broken
President Biden promised to crack down and put an end to the problem in 2016, but he has so far failed to deliver.
By law, the FDA could impose a fine of over $13,000 per day for each day a trial result is not reported. To date, the FDA has only sent four final warning letters to law-breaking institutions, and has not imposed a single fine.
Similarly, the National Institutes of Health have been dragging their feet on publicly funded trials that never make their results public.
The 2007 FDA Amendments Act (FDAAA), which was passed by an overwhelming bipartisan majority in both houses of Congress, requires companies, universities and hospitals running clinical trials to make their results public within one year of trial completion.
Can you support TranspariMED’s work?
Another day, another study: The results of over a hundred clinical trials involving people dying from cancer have never been made public. In addition to keeping up the pressure on the FDA to enforce the law, TranspariMED would love to dig through the dataset and chase up the sponsor of every single one of those trials – but right now, we simply lack the resources to do that.
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Note on study methodology
TranspariMED was not involved in designing or implementing the study discussed in this blog. The study team searched the ClinicalTrials.gov registry for trials evaluating PDAC management with a primary completion date between 1 January 2010 and 1 June 2020, and then searched both the registry and the academic literature for results. The study team did not contact the sponsors of unreported trials, which limits the study’s potential to directly improve trial reporting. However, they made the underlying dataset publicly available on Zenodo. The study itself can be accessed here.
An interesting innovation is that this study assessed whether trials were subject to U.S. legal reporting requirements. The very low FDAAA compliance rate detected may be due to the inclusion of many older trials that are not captured by the FDAAA Trials Tracker, which is widely used by institutions to monitor their trials subject to the law and improve compliance.