{"id":26683,"date":"2018-02-08T10:44:19","date_gmt":"2018-02-08T09:44:19","guid":{"rendered":"https:\/\/clarivate.com\/?p=26683"},"modified":"2018-02-08T10:44:19","modified_gmt":"2018-02-08T09:44:19","slug":"fda-guidance-recommends-diversity-clinical-trials-medical-devices-cant-require","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/blog\/fda-guidance-recommends-diversity-clinical-trials-medical-devices-cant-require\/","title":{"rendered":"FDA guidance recommends diversity in clinical trials for medical devices, but can\u2019t require it"},"content":{"rendered":"

The FDA often stresses the importance of enrolling diverse patient populations in clinical trials conducted to support product applications \u2014 both in industry guidance documents and during interactions with product sponsors. In Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies<\/em>, guidance released in September 2017, the FDA makes multiple recommendations for submissions, from advising sponsors to \u201crecruit diverse populations that ideally reflect the intended population,\u201d to suggesting they \u201cdiscuss how clinically meaningful differences across subgroups may contribute to differences in benefit-risk profile in certain subpopulations.\u201d1<\/sup> When applicable, sponsors should also \u201csubmit and publicly report study demographics, including proportion by subgroup and comorbidities.\u201d<\/p>\n

But the words \u201cContains Nonbinding Recommendations\u201d appear at the top of each of the document\u2019s 36 pages \u2014 just as they do on most pages of recent FDA industry guidance. In bolded italics, the words suggest that sponsors have some leeway when it comes to heeding FDA guidance. And, to a large degree, they do: Industry guidance is not legally enforceable.<\/p>\n

\u201cIt\u2019s not that, if you don\u2019t follow [FDA guidance], you have violated a law,\u201d explained attorney Alan Minsk, a partner at Arnall Golden Gregory, in an interview. \u201cYou don\u2019t have to take it, but if you don\u2019t take it, at least think about it.\u201d FDA guidance documents often outline specific methodologies and approaches to product development that, if followed, should yield data to support a product\u2019s safety and efficacy, the underlying standards on which the FDA approves or denies applications. Industry guidance \u201cis kind of a word to the wise,\u201d Minsk said. The agency cannot formally deny an application just because a sponsor took another route. Sponsors are free to develop alternative ways of meeting those underlying standards, but it\u2019s up to the FDA to judge whether an alternative satisfies relevant statutes and regulations, generates results demonstrating safety and efficacy and merits approval.<\/p>\n

Researchers from Yale University and the University of California-San Francisco recently concluded that sponsors evaluating the safety and efficacy of proposed devices rarely account for the potential influence of a patient\u2019s sex, age or race and\/or ethnicity, despite FDA recommendations. A research team examined labels and Summaries of Safety and Effectiveness Data (SSEDs) for each of the 42 original premarket approval (PMA) devices approved in 2015 by the FDA. In all, sponsors performed 82 studies to support the 42 approved PMA applications.<\/p>\n

The researchers collected data on the number of patients enrolled according to age, sex and race and\/or ethnicity, and also determined whether sponsors had analyzed study results by age, sex and race and\/or ethnicity. If they had, the researchers looked to see whether the sponsor had identified a difference in device safety or efficacy.<\/p>\n

Their findings appear in the September 2017 issue of JAMA Internal Medicine.<\/em>2<\/sup> Overall, sponsors analyzed study results according to age, sex and race and\/or ethnicity for fewer than 20% of studies performed to support original PMA devices approved in 2015. Other findings include:<\/p>\n