In a review of studies between 2008 and 2012, researchers from Duke University found that trials funded by industry were the most likely to be publicly disclosed in a timely fashion, when compared to studies from academia. But even in the case of industry-funded research, compliance was still found to be poor.
“The public, as well as health care providers, want ‘open science,’” said Eric Peterson, executive director of the Duke Clinical Research Institute and co-author of the paper. “This study demonstrates that despite national laws, industry- and especially NIH-sponsored trials have a long way to go.”
An average of just 13.4% of eligible studies reported findings within the required one-year window, which was mandated under FDAAA (Food and Drug Administration Amendments Act). For industry-sponsored trials, the rate was 17%, though for trials funded by academic or government sources other than the NIH it was 5.7%, and 8.1% for NIH-funded trials.
“Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding,” researchers said. “A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the NIH and 9% of trials that were funded by other government or academic institutions.”
The penalty for failing to submit data before the one-year reporting deadline can run high as $10,000 a day and/or the loss of NIH funding, but enforcement has not occurred, researchers found, especially as a Notice of Proposed Rulemaking for the FDAAA was released in November 2014 and the period for public comment has recently been extended to March 23, 2015.
The NIH also recently issued a draft policy to mandate reporting for all clinical trials funded by the agency, regardless of whether they are subject to the current law, and researchers expect this policy will improve reporting for NIH-funded trials.
“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 lead author Monique Anderson, cardiologist and researcher at the Duke Clinical Research Institute. “Sponsors who lead clinical trials have an ethical and legal obligation to publically report their findings, whether the results are positive or negative.”