CERSI P.I. and Collaborator: C. Daniel Mullins, Ph.D., Professor and Chair, Department of Pharmaceutical Health Services Research UMB, Cynthia Baur, Ph.D., University of Maryland, College Park
FDA SMEs and Collaborators: Michelle Tarver, MD, Ph.D., FDA CDRH, Jessica Weinberg, MPP, CDRH/OST, Jose Medina-Torres, DrPH, MPH, CHES, CDRH/OCE


Regulatory Science Challenge

One of the FDA regulatory science priority areas is to develop methods and tools to improve its regulated products’ evaluation after their approval for public use. It is important for the FDA to include subpopulation groups in this evaluation based on age, sex, race and ethnicity. Part of this evaluation is to assess how best to provide comprehensive and useful communications about the regulated product. 

Project Description and Goals

This ultimate goal of this project is to develop accurate and meaningful communications about COVID-19 testing in general and specifically to underrepresented populations. To achieve this goal, we aim to understand underrepresented populations’ attitudes toward COVID-19 testing and their willingness to share their data in national information banks. What we learn from this study will help the FDA Center for Devices and Radiological Health (CDRH) tailor its health messages and inform its outreach efforts for monitoring COVID-19 spread and genetic changes.    

To achieve these aims, the University of Maryland School of Pharmacy PATIENTS Program and University of Maryland at College Park collaborators will conduct a qualitative study using virtual focus group discussions and key informant interviews to gather information from underrepresented participants in the greater Baltimore area. Three to five participants per group with approximately 10-12 members per population of interest, implying a total of 3-6 key informant interviews or focus groups per population. 

Target underrepresented population groups include:

  1. African Americans across the age spectrum
  2. Individuals whose primary language is Spanish across the age spectrum
  3. Older adults regardless of race or ethnicity
  4. People wth lower literacy or health literacy
  5. People with chronic conditions
  6. Asymptomatic individuals with COVID-19 test positive household member(s)

Learn more on the U.S. Food and Drug Administration website.