FDA looks on while major U.S. institutions violate medical research rules

The FDA has issued warnings to only a handful of the companies and institutions with the worst track records of violating a key clinical trial disclosure law, a new report finds.


Out of 51 large US-based companies and institutions that have failed to make five or more clinical trial results public, only three have been contacted by the U.S. drug regulator, and only one has received a final warning, FDA enforcement data show.


Failing to rapidly make clinical trial results public on the American trial registry harms patients because it slows down medical progress, leaves gaps in the medical evidence base, and wastes public funds.



TEN WORST LAWBREAKERS


Topping the list of law-breaking institutions is the University of Virginia, which has failed to make public the results of 27 clinical trials, followed by Henry Ford Health System (19 missing results) and the University of Southern California (17 missing results).



REPORTING PERFORMANCE VARIES STRONGLY


All 16 due clinical trials sponsored by for-profit company Cutera are still missing results on the American trial registry, giving it a rock bottom reporting rate of 0%. Henry Ford Health System (17%) and Albany Medical College (17%) also routinely violate the law.


In contrast, Massachusetts General Hospital has a far higher compliance rate of 87%. (However, many of the largest pharma companies and universities in the United States have compliance rates of 100%.)



FDA ENFORCEMENT MISSES BIGGEST FISH


To date, none of the ten worst violators have been contacted by the FDA.


Between July 2020 and the end of April 2021, the FDA sent out only 54 “Pre-Notices of Noncompliance” that flagged missing trial results and instructed sponsors to make them public as required by law. When the FDA did send letters, it triggered compliance in over 90% of cases.


Under the FDA Amendments Act, a law passed in 2007 with overwhelming bipartisan support, the agency could be collecting $1.5 million in fines every day from those ten sponsors alone.



LIST OF ALL MAJOR LAWBREAKERS


Below the list of all major US-based clinical trial sponsors that have failed to make five or more clinical trial results public as required by law, and the corresponding FDA warning letters. Sponsors with a reporting rate of 0% are highlighted red.


MAJOR UNIVERSITIES RESPOND


TranspariMED contacted the institutions with the largest number of missing results for comment. Only five responded. All indicated that they were aware of the issue and were working to fix it. (See the report for full statements; USC statement below).


The University of South Florida did not provide a statement, but it has uploaded many of its missing results in the weeks following outreach by TranspariMED. As a result of the university’s efforts, its reporting performance has already significantly improved to 80%, illustrating that even academic sponsors can make rapid transparency gains.



COCHRANE US NETWORK: FDA MUST ACT


Tiffany Duque, Senior Officer at the Cochrane US Network, said:


"Access to results from all clinical trials is essential to truly evidence-based decision making, yet this study makes clear that data from many trials are still missing. Cochrane systematic reviews rely on the availability of this data."


"We strongly encourage sponsors to upload results from all missing trials for which they are responsible as a matter of urgency, and for the FDA to do more to enforce trial transparency."


Till Bruckner, founder of TranspariMED, said:


“Faced with thousands of missing clinical trial results, the Food and Drug Administration is sending out an average of just six letters per month, and those few letters fail to target the worst offenders."


"This is clearly not what Congress had in mind when it passed the law requiring these trial results to rapidly be made public, and falls far short of the expectations of medical professionals, patients and taxpayers.”


“This is a race against time. Unless the Food and Drug Administration significantly ramps up its enforcement efforts, and does it very soon, data from thousands of medical studies costing billions of dollars to run could become lost forever.”


Daniel Shapiro, Assistant Vice President, University of Southern California Office of Culture, Ethics and Compliance, said:

“The university is committed to the timely disclosure of clinical trial information and results and monitors trials to ensure reporting of research results in the manner called for by the ClinicalTrials.gov registry and database. When research results may not have been reported in a timely manner or there may be an administrative error associated with a submission, the university engages with researchers to provide administrative assistance to facilitate appropriate submission, updating and correction of reported data as needed.”

“Over the course of the last year and a half, the COVID-19 pandemic has adversely impacted the management and completion of clinical trials at USC and institutions around the world. As we resume closer to normal operations, USC and its researchers are focused on the completion of clinical trials and associated reporting of research results.



TranspariMED will publish a follow-on report early next year to document sponsors’ progress over time.


Click below to download the full report by TranspariMED.

TranspariMED report_FDAAA violations_20211122
.pdf
Download PDF • 564KB

Note: The FDA enforcement data cited in this blog and report were shared with TranspariMED by a group of external researchers. TranspariMED did not include the raw data in its report, but they have since been made public. They can be downloaded using the link at the bottom of this blog by Universities for Essential Medicines.



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