When patients lack sufficient treatment options for serious medical conditions, they rely on\nthe prompt approval and development of new therapeutic alternatives, such as medical devices.\nUnderstanding the development of innovative medical devices, including the characteristics\nof premarket clinical trials and length of Food and Drug Administration (FDA)\nreview, can help identify ways to expedite patient access to novel technologies and inform\nrecent efforts by FDA to more quickly get these products to patients and physicians. We analyzed\npublicly available information on clinical trials and premarket FDA review for innovative\nmedical devices that fill an unmet medical need. In this first-of-its-kind study focusing on\nthese products, we extracted data on the length of the pivotal trials, primary study endpoint\nand FDA review; number of patients enrolled in trials; and in what country the device was\navailable first. We identified 27 approved priority review devices from January 2006 through\nAugust 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3\nmonths to approximately 7 years. Trials had a median primary outcome measure evaluation\ntime of one year and a median enrollment of 297 patients. The median FDA review time\nwas 1 year and 3 months. Most priority review devices were available abroad before\nthey were approved in the United States. Our study indicates that addressing the length of\nclinical studiesââ?¬â?and contributing factors, such as primary outcome measures and enrollmentââ?¬â?\ncould expedite patient access to innovative medical devices. FDA, manufacturers,\nCongress and other stakeholders should identify the contributing factors to the length of\nclinical development, and implement appropriate reforms to address those issues.
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