Four prominent medical research institutions and two medical device companies continue to violate U.S. clinical trial disclosure requirements on a large scale, highlighting the failure of the U.S. Food and Drug Administration to effectively enforce the law, data compiled by TranspariMED show.
Overall, 3,480 clinical trial results are still missing from the public ClinicalTrials.gov registry in violation of the law, according to data from the University of Oxford’s FDAAA Trials Tracker. Nearly one in four trials (24.3%) continues to be in breach of reporting requirements set out in the 2007 FDA Amendments Act (FDAAA).
The failure of universities, hospitals, and drug and medical device companies to rapidly make clinical trial results public directly harms patients because it leaves the benefits and risks of drugs and medical devices uncertain, leading to avoidable patient deaths and the large-scale misallocation of public funds.
Against this backdrop of widespread law-breaking, the FDA has so far issued only four so-called ‘Notices of Non-Compliance’ [essentially final warning letters] to those responsible for making trial results public. In each case, the party responsible promptly uploaded the missing result.
By law, the FDA could be issuing fines of over $13,000 per day for each overdue trial result; to date, the FDA has not imposed a single fine.
Large-scale legal violations
Six American academic institutions and companies running clinical trials still owe the public the results of 10 or more clinical trials, between them accounting for a total of 86 missing results, data compiled by TranspariMED show.
The worst violator in absolute terms in Massachusetts General Hospital, with 21 missing trial results, followed by the University of Southern California and the medical device company Cutera (16 missing results each). Cutera has not reported a single one of its due trial results.
Two examples of the 86 trials run by these sponsors that are missing results on the public ClinicalTrials.gov registry illustrate how non-reporting or late reporting of trial results harms patients:
Mass General: Letting patients down
The trial aimed at evaluating the safe dosage and efficacy of a promising cancer drug. Participants had to visit the clinical multiple times and undergo blood tests and urine tests. According to the law, Massachusetts General Hospital should have made the results of this trial public over three years ago, but its results are still missing from the registry.
To date, only a brief summary of interim results appears to have been made public in the scientific literature. Therefore, other doctors treating patients with these forms of cancer remain in the dark about the full benefits and harms of this potentially effective treatment.
USC: Results of breast cancer trial missing
University of Southern California trial NCT01873833 aimed to recruit 40 women with metastatic breast cancer to evaluate the safety and tolerability of a novel cocktail of four drugs, and to track whether it would help patients to survive for longer.
The university terminated the trial early, after only 10 participants had been treated due to lack of accrual, and then failed to upload its full results. It appears that the only source of information on the trial's outcomes is a 330 word abstract that notes that "[t]he proposed regimen... appears to be active in patients with HER2 positive MBC [metastatic breast cancer] but with significant toxicity".
This leaves other researchers unable to build on this Phase II trial’s findings. Based on the little information publicly available, other researchers will struggle to decide whether the documented benefit-harm profile would justify launching a larger, follow-on trial with more patients.
A key aim of law FDAAA was to accelerate medical progress, but this cancer trial’s full results are already over six months overdue.
NIH funding wasted
The USC breast cancer trial was funded with taxpayers’ money through a grant from the National Institutes of Health (see below).
Source: ClinicalTrials.gov registry entry for trial NCT01873833, accessed 04 August 2022
A recent audit report revealed that over half of clinical trials funded by NIH failed to make their results public as required by law. NIH has so far failed to commit to audit its past grants and chase up unreported clinical trials.
FDA and NIH inaction harms patients
Till Bruckner, founder of TranspariMED, a global advocacy group that works to end evidence distortion in medicine, said:
“Fifteen years after Congress passed a common-sensical law to accelerate medical progress and enhance patient safety, over three thousand clinical trial results are still missing because the Food and Drug Administration and the National Institues of Health are dragging their feet on enforcing the rules.”
“FDA’s and NIH's inaction is causing widespread waste of public research funds and needless delays in the development of new and better medical treatments.”
“If a cancer patient participating in a clinical trial violates parking restrictions outside a hospital, she will receive a fine, but if the hospital running the trial violates the law, the FDA lets it off the hook. This is deeply unfair towards patients who volunteer their time and bodies to participate in clinical trials.”
“The FDA should immediately contact all law-breaking companies, universities and hospitals and warn them to upload their missing trial results, or else face a steep fine. NIH should refuse to issue new grants to institutions that break the law.”
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