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Incomplete and inconsistent capture of information about race and ethnicity in real-world data (RWD) limits a full understanding of the distribution, safety, and effectiveness of FDA-regulated products, which impacts the health of the public.

While race and ethnicity represent only the tip of the iceberg, collecting and measuring race and ethnicity data is an important step toward the development of safe and effective medical products and effective healthcare for all patients – especially people of color. Race and ethnicity are closely linked to disparities in access to medical products, health care, and health outcomes.

Without this vital information, the health care industry has a limited ability to describe the real-world utilization, safety, quality, and effectiveness of medical products and patient care. Gathering this data in health care settings and in partnership with communities will help communities, health care providers, administrators, researchers, life sciences companies identify patterns and trends in medical product usage, health care, and downstream health outcomes across different populations in the U.S. and develop interventions and policies to improve health outcomes and reduce health disparities.

The Reagan-Udall Foundation for the FDA, in collaboration with FDA's Office of Minority Health and Health Equity, launched RAISE to elevate the capture and curation of race and ethnicity data in health care settings to ultimately improve the quality of health care and medical products.

Hear Research Director Carla Rodriguez Watson, and CEO Susan Winckler, RPh, Esq., discuss RAISE on the OMHHE podcast.

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RAISE includes 11 community workshops from January – June 2023 covering topics that influence the continuum of race/ethnicity data in health care settings.

Through RAISE, the Reagan-Udall Foundation for the FDA:

• Convened a series of workshops with leaders across the health and health care ecosystem to create opportunities to share, learn, and build capacity to advance solutions; and

• Developed a multi-dimensional tool that will help prioritize strategies to improve the capture and curation of race and ethnicity data, based on the barriers and solutions discussed in these community meetings. 

RAISE workshops are meant to encourage active conversation and information sharing among those actively working in academic, health care, patient advocacy, regulatory, research, and related sectors.

View Meeting Summaries

 

Research Director Carla Rodriguez-Watson, PhD, MPH, discusses RAISE in a four-part series on Questions You Didn't Ask

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Listen to the podcast

 

 

 

This project is supported by the Food and Drug Administration (FDA) Office of Minority Health and Health Equity of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (FAIN) totaling $874,514 (100% funded by FDA OMHHE/HHS). The contents are those of the author(s) and do not necessarily represent the official views of nor an endorsement by FDA/HHS, or the U.S. Government.

 

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Learn more about the Foundation’s other research programs.