WIKIMEDIA, BRUCEBLAUSThe US Food and Drug Administration (FDA) makes available summaries of the clinical studies behind medical device approvals. But as researchers reported in The BMJ this month (June 10), these “are not easy to access,” and they found just half of the trials ultimately get published in the literature where clinicians might have an easier time reading them.
“This is important, as the new European Clinical Trials Regulation (which aims to improve clinical trials transparency) does not apply to clinical trials on medical devices, and previous research found that the FDA approves many of these devices on the basis of a single trial,” according to a post on the All Trials website, part of an initiative to get human studies registered and reported.
To conduct the latest analysis, Rita Redberg of the University of California, San Francisco, and colleagues collected documents from the FDA about 106 cardiovascular devices that received premarket approval between 2000 and 2010. Of the corresponding studies on these products, 49 percent were published in peer-reviewed journals by 2013.
“Even when trials are published, the study population, primary endpoints, and ...
