Racial and Ethnic Minority Acceleration for Health Equity Consortium U01

项目摘要/摘要本提案回应了FDA的OMHHE愿望 通过其覆盖范围，加快努力解决种族和少数民族问题以及卫生公平问题 财团。本次两期《健康公平加速》U01申请提交至 参加FDA OMHHE健康公平创新奖 健康公平加速联盟(REACH)(U01)“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 培训和指导各种HBCU高级学生、研究员和研究人员。这个 拟议的方案和项目受益于已建立的合作伙伴关系并得到认可 马里兰大学巴尔的摩分校的病人之间的领导力项目，牧师 Mt.黎巴嫩浸信会(Lance MLBC牧师)，农村卫生公平专家(博士)， 两所历史悠久的黑人学院/大学(HBCU)：科平州立大学(CSU) 海伦·富尔德护理学院(Dean Tilghman)和路易斯安那泽维尔大学(XULA) 药学院(迪恩·肯尼迪)。在本申请中提交的两个试点项目/计划 包括两个RFA“支柱”：“声音的公平”和“临床试验的公平”，这将是 在阶段1下开发：a)试点课程和FDA潜在的OMHHE轮换 年HBCU高级学生和教职员工的“监管问题和健康公平” 药剂学和护理学；以及b)一个超出临床试验障碍的先导性研究项目 确定制定应对临床试验多样性障碍的战略，以便 提高赞助商和研究人员的可信度和透明度，并提高意愿 参与试验。在第一阶段，规划、行政程序和后勤将 制定并在第二阶段实施试点项目和方案。具体目标 对于分两个阶段的提案： 目标1行政核心：建立行政核心(AC)以共建 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(声音的公平)：在儿童与家庭事务委员会的指导下和联合国儿童基金会的投入下共同发展 FDA OMHHE，“监管科学和健康公平”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提供服务。目标3 (临床试验的公平性)：进行试验性研究，旨在描绘战略 克服非洲裔美国人参与临床试验的障碍，以便 增加未被充分代表的少数民族、种族和民族参与临床的公平性 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.