Major American research institutions have significantly improved their clinical trial reporting, a report released today by Universities Allied for Essential Medicines shows.
The overall reporting performance of 40 leading universities has increased from 69% to 93% over the past two years. Out of 40 research institutions, 17 are now fully compliant with the law, and a large majority have reported results for more than 80% of their completed trials on ClinicalTrials.gov, a public database.
On the downside, more than half of the 40 universities are still in violation of the law, leaving 101 clinical trials missing results.
Failing to make the results of certain clinical trials results public on the database violates federal law, slows down medical innovation, and increases the risk that a trial’s outcomes will never be made public and become costly research waste.
BEST AND WORST UNIVERSITIES
The chart below shows the reporting rates of all 40 universities in February 2021 (dark blue) compared to their performance two years earlier (light blue).
At the top of the league are 13 universities that have consistently maintained a 100% reporting rate, followed by a further 4 universities that have recently achieved full compliance.
At the bottom of the ranking is the University of Cincinnati, a negative outlier with only 25% of due trial results available. The report notes that Cincinnati has to date received over $100 million in public funding for COVID-19 related research, showing that despite a promise by Joe Biden to cut off funding, institutions that flout the law continue to receive taxpayer money to launch new studies.
The universities of Colorado (Denver), Washington and Florida also perform weakly. Florida’s performance is especially disappointing - the university was fully compliant two years ago, but has since dropped the ball.
RESULTS MISSING BY UNIVERSITY
In terms of the total number of trials still missing results, the University of Colorado (Denver) performs worst with 14 missing results, followed by the University of Washington (12 results missing), NYU Langone Health (11), Cincinnati (9), Florida (7), and Stanford (7).
The report also assessed the performance of university-linked cancer centers. Overall, these perform strongly, with the exception of UCLA Jonsson Comprehensive Cancer Care Center, which currently owes the public the results of seven long-completed trials.
“We hope this report will serve as a point of celebration for the improvements made by universities, but also as a reminder that universities must continue to be held accountable for reporting research results. We can only declare victory once all universities have reported 100% of their clinical trials, as mandated by the law.”
UNIVERSITIES RUN RISK OF LARGE FINES
The US Food and Drug Administration (FDA) recently started the process of imposing fines on institutions that violate the transparency requirements set out in the 2007 FDA Amendments Act. The law empowers the FDA to levy a fine of over $12,000 for every day a trial result remains missing.
The FDA’s move, which set alarm bells ringing at many universities, may embolden the National Institutes of Health and other public funding institutions to turn down future grant applications from persistent law-breakers like the University of Cincinnati, as promised by Joe Biden.
The data for the report was collected in February 2021 using the FDAAA Trials Tracker. The Tracker includes only trials subject to the law that have come due in recent years. A recent court case extended the scope of the law to older trials stretching back to 2007. No tracking tool for these older trials exists, so companies and universities will have to manually review their trial portfolios to identify all potential legal, financial and reputational risks.
A CLOSER LOOK AT REPORTING PERFORMANCE
A separate study published earlier this week by a team from the University of Oxford painted a more sombre picture of trial reporting in the Unites States, finding that 60% of all trials subject to the law had not made their results public within the legal deadline.
The study measured reporting performance in terms of whether results had been made public within 12 months of trial completion, as demanded by the law. (In contrast, Universities Allied for Essential Medicines only assessed whether trial results were available at all, not whether they had been made available on time.)
Trials run by small companies and universities were substantially more likely to be reported late or not at all.
On the positive side, nearly 90% of studies were registered on time, and three quarters of study records were being updated at least once a year. The latter figure contrasts favourably with the lax data management practices prevalent in Europe, whose trial registry is riddled with out-of-date information.
TRIAL REGISTRY DATA "ESSENTIAL" FOR COVID RESEARCH
A commentary published alongside the study noted that:
“Although these requirements can seem onerous and bureaucratic, they essentially codify good scientific and ethical reporting practices. Out-of-date, incomplete, or inaccurate trial information can distort understanding of the evidence base and the research landscape.”
“The database is not only an information resource for individual clinical trials, but also essential for identifying all trials studying particular research questions. For example, without ClinicalTrials.gov, there would be no way to know how many COVID-19 trials had been initiated, what drugs or other interventions were being evaluated, when the trials would be completed, and, ultimately, what the trials found.”
“If academic medical centers are to retain the trust of potential trial participants, they must increase their focus on training, support, and oversight of trial reporting.”
Links to studies discussed in this blog: