Investigators 

  • Claudia R Baquet, MD, MPH, PhD, PATIENTS Program, University of Maryland School of Pharmacy 
  • Jasmine Cooper-Williams PhD, MA, PATIENTS Program, University of Maryland School of Pharmacy 
  • Joan Tilghman, PhD, RN, CRNP, WHNP-BC, CNE, Interim Dean, Coppin State University
  • Kathleen Kennedy, PharmD, Dean, Xavier University of Louisiana

Project Summary 

This two-phase “health equity acceleration” U01 responds to FDA’s OMHHE desire to accelerate efforts to address racial and ethnic minority and health equity through its REACH Consortium. This project is focused on advancing “minority health and health equity focused research, outreach, and communications as well as supports training and mentoring of diverse HBCU advanced students, fellows, and researchers.” Two pilot projects/programs will be developed under Phase 1, and subsequently implemented under Phase 2.

  1. A pilot program on “Regulatory Issues and Health Equity” and FDA OMHHE rotations for advanced students and faculty in HBCUs in Pharmacy (Xavier University of Louisiana College of Pharmacy) and Nursing (Helene Fuld College of Nursing and the College of Health Professions at Coppin State University).
  2. A pilot research project which will transcend identifying barriers to clinical trials participation amongst African Americans/Blacks, to develop strategies to enhance clinical trial diversity. The pilot project seeks to unearth participant-identified mechanisms to increase trustworthiness, enhance transparency in sponsors and researchers, and bolster willingness to participate for African Americans, thereby strengthening equity in participation of underrepresented minority racial and ethnic groups in clinical trials.

Populations Served 

Black or African American, White, and Hispanic or Latino.  

Goals/Aims 

The aims for the project are as follows:

  1. To co-develop, with stakeholder and FDA OMHHE guidance, a curriculum and FDA rotations on “Regulatory Science and Health Equity,” for HBCU fellows, postdoctoral researchers, faculty, and graduate students. The Pilot training program will reinforce health equity acceleration and FDA’s interaction, engagement, mentoring and communication with relevant stakeholders and organizations; increase representation of HBCUs and community perspectives; and will ensure diverse and underrepresented groups understand FDA’s roles and responsibilities. 
  2. To conduct pilot research designed to delineate evidenced-based strategies for overcoming identified barriers to clinical trials participation for African Americans, to increase equity in participation of underrepresented racial and ethnic minority groups in clinical trials. The pilot project will support innovative models of clinical trial design, recruitment, and enrollment. Pilot research will entail qualitative analysis of town hall meetings with 100 urban and rural African Americans/Blacks, which will result in action guides for trial sponsors and others surrounding strategies to overcome barriers to clinical trial diversity.

Preliminary Key Findings

  • In progress  

Publications/Abstracts/Posters, etc. 

  • In progress

Age

18-64; 65 and above 

Geographic Location

Maryland, Louisiana 

Rural

Yes