title: Characteristics of pivotal trials and FDA review of innovative devices.
abstract: When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.
authors: The Pew Charitable Trusts, Washington, District of Columbia, United States of America.
authors: Joshua P
authors: JP
authors: Rising
authors: The Pew Charitable Trusts, Washington, District of Columbia, United States of America.
authors: Ben
authors: B
authors: Moscovitch
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D057176:Compassionate Use Trials; D018795:Device Approval; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
references: Palliat Med. 2006 Dec;20(8):745-54
references: 17148529
references: Leuk Res. 2015 Mar;39(3):335-41
references: 25597017
references: Pediatrics. 2014 May;133(5):e1197-202
references: 24733871
references: J Support Oncol. 2008 Apr;6(4):168-74
references: 18491685
references: BMJ. 2011 May 13;342:d2748
references: 21572130
references: J Hosp Palliat Nurs. 2010 Sep 1;12(5):312-318
references: 20936087
references: BMJ. 2001 Mar 10;322(7286):603-5
references: 11238162
references: Milbank Q. 2014 Mar;92(1):114-50
references: 24597558
references: Circulation. 2004 Jun 29;109(25):3068-72
references: 15226221
references: BMJ. 2014 Jan 17;348:g217
references: 24443478