Many leading US universities are breaking the law by failing to make public the results of their clinical trials.
A report published on 25 March found that 25 of the 40 universities that sponsor the most trials in the United States did not post study results on a public, government register within 12 months of completion, as is required by US law.
The results of 31% of trials sponsored by these universities since January 2017 that were due to be reported couldn’t be found on the repository, says the analysis, which was carried out by organizations that campaign for transparency in medical research.
“Without access to all the data, clinicians and public-health authorities can’t decide which drugs or medical devices are the most effective, and patients’ health suffers when they get sub-optimal treatments,” says the report’s lead author Till Bruckner, founder ofTranspariMED in Bristol, UK.
A 2007 federal law requires that the results of most trials of drugs and medical devices be posted on the site ClinicalTrials.gov within one year of completion. Some types of study, such as phase I safety trials, are excluded from this mandate. The law came fully into effect in January 2017.
Bruckner and colleagues looked at 450 trials completed by the 40 universities, and found that the results of 140 studies were missing from the public registry.
Using data taken from the FDA Amendments Act (FDAAA) TrialsTracker website on 28 February, the researchers found that Columbia University in New York City had reported the lowest proportion of trials on time — 17%. The University of California San Francisco had the largest number of unreported trials, at 17, or 37%, of its total, according to the report.
A spokesperson for Columbia University Irving Medical Center said that only 8 of the 15 studies cited as late in the report had been completed, 5 were still ongoing and one had been closed because it had failed to enrol any participants. The results of another study had been submitted but not yet posted to the registry, it said.
A University of California San Francisco spokesperson said that of its unreported studies — which now stand at 18 — 10 trials were overdue, 4 had either incomplete results or were going through data analysis, 2 had been updated but were not yet on ClinicalTrials.gov and the completion dates of 2 others had changed.
Fifteen of the 40 universities — including Washington University in St. Louis in Missouri and Yale University in New Haven, Connecticut — had complied fully with the law.
However, the report suggests that US academic institutes have become better at reporting trial results since the law took effect; in 2015, an investigation by biomedical news outlet STAT revealed that 90% of all trials sponsored by US academic institutions between 2008 and 2015 did not have their results reported within a year.
Advocates point out that the US Food and Drug Administration (FDA) has the power to fine the sponsors of unreported trials up to US$10,000 per day, but that it has not issued any penalties so far. In September, the FDA announced draft guidance on how it will enforce the law.
“People participate in trials on the understanding that their data will be made available to benefit society and humanity at large, so failing to publish it is a violation of that,” says Erick Turner, of the Center for Ethics in Health Care at Oregon Health & Science University in Portland, and a former FDA clinical reviewer.
The problem of missing trial data is not restricted to the United States. An analysis published1 in September found that 89% of trials sponsored by academic institutions in the European Union were not reported within a year, as is required by EU law.