Racial and Ethnic Minority Acceleration for Health Equity Consortium U01

项目概要/摘要本提案响应了FDA的OMHHE愿望， 加快努力，通过其REACH法规解决种族和族裔少数群体以及健康平等问题 财团这两个阶段的“健康公平加速”U 01申请提交给 参加FDA OMHHE健康公平创新奖“种族和少数民族 健康公平加速联盟（REACH）（U 01）”专注于推进“少数群体 以健康和健康公平为重点的研究、推广和沟通以及支持 培训和指导不同的HBCU先进的学生，研究员和研究人员。的 拟议的计划和项目受益于已建立的伙伴关系，并得到认可 领导之间的病人计划在马里兰州巴尔的摩大学，牧师 山黎巴嫩浸信会（牧师兰斯MLBC），农村卫生公平专家（博士Datcher）， 和两所历史上的黑人学院/大学（HBCU）：科平州立大学（CSU） Helene Fuld护理学院（Dean Tilghman）和路易斯安那州泽维尔大学（Xavier University of Louisiana） 药学院（院长肯尼迪）。本次申请中提交的两个试点项目/计划 包括两个RFA“支柱”，即“声音公平”和“临床试验公平”， 在第1阶段开发：a）试点课程和潜在的FDA OMHHE轮换， “监管问题和健康公平”在HBCUs先进的学生和教师， 药学和护理;以及B）一个超越临床试验障碍的试点研究项目 识别并制定解决临床试验多样性障碍的策略，以便 提高赞助商和研究人员的可信度和透明度，并提高参与的意愿 参加审判。在第一阶段，规划、行政程序和后勤将 在第二阶段，将实施试点项目和方案。具体目标 关于两阶段提案： 目标1行政核心：建立行政核心（AC）， 社区和卫生专业咨询委员会（CHPAB）的政策和程序 为了培养与FDA OMHHE及其REACH联盟的有效互动。 目标2（声音的平等）：在CHPAB的指导下， FDA OMHHE，关于“监管科学和健康公平”的课程，以及潜在的轮换 在FDA OMHHE为HBCU研究员，博士后研究人员和研究生。AIM 3 （临床试验中的公平性）：开展试点研究，旨在描述以下策略： 克服非裔美国人参与临床试验的障碍， 增加代表性不足的少数种族和族裔群体公平参与临床 审判

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.