Racial and Ethnic Minority Acceleration for Health Equity Consortium U01

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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.