PROJECT SUMMARY/ABSTRACT This proposal responds to FDA's OMHHE desire to
accelerate efforts to address racial and ethnic minority and health equity through its REACH
Consortium. This two-phase “health equity acceleration” U01 application is submitted to
participate in the FDA OMHHE Health Equity Innovation Award for “Racial & Ethnic Minority
Acceleration Consortium for Health Equity (REACH) (U01)” focused on advancing “minority
health and health equity focused research, outreach, and communications as well as support
training and mentoring of diverse HBCU advanced students, fellows, and researchers.” The
proposed program and projects benefit from established partnerships and recognized
leadership between the PATIENTS Program at the University of Maryland Baltimore, the Pastor
of Mt. Lebanon Baptist Church (Pastor Lance MLBC), a rural Health Equity expert (Dr. Datcher),
and two Historically Black Colleges/Universities (HBCUs): Coppin State University (CSU)
Helene Fuld School of Nursing (Dean Tilghman), and Xavier University of Louisiana (XULA)
College of Pharmacy (Dean Kennedy). Two pilot projects/programs submitted in this application
encompass two RFA “pillars' of “equity of voices” and equity in clinical trials” which will be
developed under Phase 1: a) A Pilot curriculum and potential FDA OMHHE rotations on
“Regulatory Issues and Health Equity” for advanced students and faculty in HBCUs in
Pharmacy and Nursing; and b) A Pilot research project which more beyond clinical trial barrier
identification to development of strategies to address barriers to clinical trial diversity, in order to
increase trustworthiness, transparency in sponsors and researchers, and increase willingness to
participate in trials. In Phase 1, planning, administrative procedures and logistics will be
developed and in Phase 2, the pilot project and program will be implemented. SPECIFIC AIMS
for the two-phase proposal:
AIM 1 ADMINISTRATIVE CORE: Establish the Administrative Core (AC) to co-institute
policies and procedures with the Community and Health Professional Advisory Board (CHPAB)
in order to cultivate effective interactions with the FDA OMHHE and its REACH Consortium.
AIM 2 (EQUITY OF VOICES): Co-develop, with guidance of the CHPAB and input from the
FDA OMHHE, a curriculum on “Regulatory Science and Health Equity,” and potential rotations
at FDA OMHHE for HBCU fellows, postdoctoral researchers, and graduate students. AIM 3
(EQUITY IN CLINICAL TRIALS): Conduct pilot research designed to delineate strategies for
overcoming identified barriers to clinical trials participation for African Americans, in order to
increase equity in participation of underrepresented minority racial and ethnic groups in clinical
trials.