A U.S. federal court has ruled that clinical trial sponsors – including pharma companies, device manufacturers and universities – must make public the results of hundreds of clinical trials conducted prior to 2017.
The ruling marks a victory for transparency campaigners, who had filed a strategic lawsuit challenging the Food and Drug Administration and the National Institutes of Health over their decision to exempt pre-2017 trials from a law requiring trial results to be made public on the American trial registry Clinicaltrials.gov.
According to STAT News:
“Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs - meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data.”
Legal expert Christopher Morten told STAT News that:
“[The ruling] makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret. This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA.”
Investigative journalist Charles Seife, a co-plaintiff in the case, commented that:
“The FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it's nearly impossible to understand whether the agency is doing its job properly. ClinicalTrials.gov is a key source of this data.”
Joseph Ross, Professor of Medicine and Public Health at Yale, said:
“This is an extraordinary victory for patients and clinical trial researchers. The government now has a clear legal obligation to enforce these reporting requirements, and by doing so it will promote more fully-informed decision-making by patients and their clinicians.”
A recent study by Nicholas DeVito and colleagues showed uneven compliance with the law, the FDA Amendments Act, even in relation to post-2017 trials where disclosure is clearly and unambiguously mandatory. It found that 36% of trials subject to the law – a total of 1,523 trials of medicines and medical devices – were missing results. The authors noted that “patients and clinicians cannot make informed choices when the results of clinical trials are routinely withheld”.
Under the law, the FDA is entitled to impose a fine of over $12,000 for every day of delay in posting a clinical trial result. If the FDA was enforcing the law, it could by now have collected nearly $7.9 billion in fines, data by the FDAAA Trials Tracker shows.
A recent investigation by Science magazine found that the FDA has so far not imposed any fines on trial sponsors. Also, the National Institutes of Health have broken a 2016 promise to withhold grant funding for those who violate the law.
While some of America’s largest medical universities and hospitals have improved their compliance in recent years, many are still in breach of the law. For example, University of Virginia has failed to post 76% of its trial results. The Children's Hospital Medical Center in Cincinnati performs even worse; 81% of its trials are missing results.
Use the tracker to check your local university’s or hospital’s performance.
A public consultation launched by the FDA demonstrated that patients, doctors and health experts strongly support the imposition of fines.
According to a 2018 World Health Organisation document:
“Legislation or supporting regulations… [should] require all clinical trials to be registered… prior to commencing the trial, public disclosure of results of any newly conducted clinical trial, public disclosure of unreported results for clinical trials conducted in the past, [and] sanctions if a clinical trial is not registered and / or results are not reported.”
A spokeswoman for the Department of Health and Human Services told STAT News that the agency was “evaluating the Court’s decision with the Department of Justice to determine our next steps.”