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AAMC Submits Letter to FDA on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

September 16, 2016—The AAMC Sept. 15 submitted  a letter to the Food and Drug Administration (FDA) regarding the collection, reporting, and evaluation of age, race, and ethnicity data in medical device clinical studies. The request for comment was published in the June 20 Federal Register

In its letter, the AAMC supports the FDA’s efforts to seek more information about racial/ethnic and age group differences in treatment outcomes in order to better inform healthcare decisions of providers and patients and to reduce disparities in the diffusion and generalizability of knowledge about the risks and benefits of medical device use. 

The AAMC recommends the FDA suggest all studies consider the collection of race, ethnicity, and age data, not solely those for which subgroup differences are anticipated. Furthermore, the association encourages the FDA to enhance recruitment efforts by identifying effective communication pathways and building strong community partnerships. The AAMC also suggests the FDA offer more specific guidance on the activities, tactics and strategies – developed in partnership with patients and communities – that will yield success.  

Given the significant health disparities experienced by veterans, persons with disabilities, and LGBT and rural populations, the AAMC also recommends the FDA broaden its current efforts to include these populations, who are also often underrepresented in clinical trials.

Contact:

Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522
Email: palberti@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org