A database analysis found that 80 percent of the studies of high-risk cardiovascular devices that the FDA approved between January 2011 and December 2013 reported their results in peer-reviewed biomedical literature, an increase from a 49 percent rate for similar devices between January 2000 and December 2010.
The improvement in publication rate coincided with the passage of the 2007 FDA Amendment Act, which made medical devices subject to registration and reporting requirements on ClinicalTrials.gov.
Lead researcher Adam T. Phillips, MD, of the Yale University School of Medicine in New Haven, Conn., and colleagues published their results online in JAMA Internal Medicine on Feb. 22.
They searched the publicly accessible FDA PMA (premarket approval) database and identified the novel, high-risk cardiovascular devices approved between January 2011 and December 2013. They also identified the studies supporting the approvals by searching FDA documents and corresponding publications as well as ClinicalTrials.gov.
During that time period, the FDA approved 35 novel, high-risk cardiovascular devices via the PMA pathway. Of the 70 studies supporting the approvals, 56 were published in peer-reviewed literature and five additional studies reported results on ClinicalTrials.gov.
The researchers found that 89 percent of pivotal studies, 69 percent of nonpivotal studies, 94 percent of studies of devices designated as life-sustaining, 66 percent of studies designated as non-life-sustaining, 87 percent of studies funded by public companies and 56 percent studies funded by private companies were published in peer-reviewed literature.
“Improved publication rates, particularly among public companies, are probably a consequence of the explicit inclusion of medical devices in the 2007 FDA Amendment Act expansion of ClinicalTrials.gov registration and reporting requirements,” they wrote. “However, recent failures of high-profile cardiovascular devices may also have led patients and physicians to more frequently ask about the evidence supporting newly approved devices, prompting publication by companies seeking clinical adoption of their products.”