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Study highlights improved publication rates of studies supporting FDA premarket approval of high-risk CV devices
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From 2011 to 2013, eight of 10 studies supporting FDA approval of novel, high-risk CV devices were published in peer-reviewed biomedical journals, an improvement from the 49% publishing rate for trials from 2000 to 2010, according to a research letter published in JAMA Internal Medicine.
Adam T. Phillips, MD, from the department of internal medicine, Yale University School of Medicine, and colleagues conducted a review of the publication of studies supporting FDA premarket approval for CV devices from 2011 to 2013 to investigate whether the 2007 FDA Amendments Act, which required medical devices to be registered on ClinicalTrials.gov, has led to an improvement in publishing research on medical devices.
The researchers identified 35 novel, high-risk CV devices that were issued FDA premarket approval from 2011 to 2013 through the FDA premarket approval database. Then through searches of FDA documents, biomedical journals and ClinicalTrials.gov, Phillips and colleagues discovered 70 studies supporting the FDA approval of the devices, 56 of which were published in biomedical journals.
According to the findings, studies of devices considered life-sustaining were more likely to be published than those classified as nonlife-sustaining (94% vs. 66%; P = .004). Studies considered pivotal also had a better publication rate than nonpivotal studies (89% vs. 69%; P = .03). The type of company funding the study was another important predictor of publication; those funded by public companies had a higher publication rate than those supported by private companies (87% vs. 56%; P = .006).
Phillips and colleagues also assessed the accuracy of study results reported in the journals to see whether there were any misinterpretation of the data. Of the 56 published studies, three reported primary outcome results that were different from the FDA review; one of which, as a result, published a different interpretation of the findings.
The improved publication rates were most likely due to the 2007 FDA Amendments Act, but that “recent failures of high-profile [CV] 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,” Phillips and colleagues wrote.
The researchers concluded that these results are encouraging, but “efforts to improve the accessibility of results through online FDA resources and within medical device labels may still be needed to ensure dissemination of historical studies.” – by Tracey Romero
D isclosure: One of the researchers reports receiving funding from Johnson & Johnson and Medtronic through Yale University to develop methods of clinical trial data sharing; from CMS to develop and maintain performance measures that are used for public reporting; from Blue Cross Blue Shield Association to better understand medical technology evidence generation; and from the FDA to develop methods for postmarket surveillance of medical devices. The other researchers report no relevant financial disclosures.
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