The pharmaceutical industry takes a lot of criticism from many angles, but when it comes to reporting the results of its clinical trials, the ivory towers of academia turn out to be the irresponsible ones. According a new report, many publicly-funded clinical trials do not comply with guidelines of the US Food and Drug Administration for timely outcomes reporting. In contrast, industry-funded studies were much more likely to comply with regulations, the study reveals.
Researchers with Duke Medicine reported in the March 12 issue of The New England Journal of Medicine that far too many clinical trials fail to comply with mandates for reporting results during and shortly after the conclusion of certain clinical trials. Legal and ethical guidelines require that the results of most clinical trials for medical products are to be reported in a registry created for this specific purpose so that all results of studies with human subjects are made public in a timely fashion.
The researchers looked at 13,327 “highly likely applicable clinical trials,” or HLACTs from 2008 through 2013. They found that the proportion of HLACTs funded by all sources that reported results within the FDA-mandated 12-month window was only 13.4 percent. Those that eventually reported results by September 2013 accounted for only 38.3 percent. Among the HLACTs examined, 65.6 percent were funded by industry, 45 percent of which were not required to report results. Six percent of the HLACTs were funded by the National Institutes of Health, and 9 percent were funded by other government or academic institutions.
“Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results,” said study lead author Monique Anderson, M.D., researcher at the Duke Clinical Research Institute, in a statement. “Sponsors who lead clinical trials have an ethical and legal obligation to publically report their findings, whether the results are positive or negative.
