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.
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.
Despite the known racial disparity of COVID-19, race data was >30% missing among persons with lab-confirmed COVID-19 in one-third of large data organizations participating in the COVID-19 Diagnostics Evidence Accelerator.
(Source: Diagnostics Evidence Accelerator Parallel Analysis)
RAISE will include 11 community workshops from January – June 2023 covering topics that influence the continuum of race/ethnicity data in health care settings.
Community Workshop Series
|1||Jan 26||Improving the Collection and Curation of Race & Ethnicity Data in Health Care|
|2||Feb 2||Collecting Better Data I: Incentives, Framework, and Mission|
|3||Feb 16||Collecting Better Data I: System Requirements|
|4||Mar 2||Creating Safe Space I: Reporting Race 101|
|5||Mar 16||Creating Safe Space I: Capturing Race and Ethnicity Data|
|6||Apr 6||Interoperability, Reporting, and Data Privacy|
|7||Apr 20||Factors Contributing to Missingness, Misclassification, and Measurement Bias|
|8||May 4||Advanced Analytics - Novel ways to Apply Existing Race & Ethnicity Data|
|9||May 18||Advanced Analytics - Interim Solutions when Race & Ethnicity are Missing|
|10||Jun 1||Health System Reactions|
|11||Jun 15||Summary - Visioning & Next Steps|
Through RAISE, the Reagan-Udall Foundation for the FDA will:
• Convene 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
• Develop 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.
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 $499,514 (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.