University of Arizona - Banner Health Precision Medicine Initiative Cohort Enrollment Center

摘要 在这项拨款申请中，我们建议建立亚利桑那大学健康科学-班纳健康 (UA-Banner)以招聘为主要目的的医疗保健提供者组织(HPO)注册中心 绝大多数(50%-70%)美国印第安人/阿拉斯加原住民(AI/An)和西班牙裔/拉丁裔(Hisp/Lat) NIH精密医学倡议队列计划(PMI-CP)所需的参与者，该计划将首先注册 一百万名参与者。PMI-CP是一个及时的发展，将促进在 基因组学、新陈代谢学和健康技术，以减少健康差距，这些都有助于 过度痛苦、残疾、过早死亡和经济损失，特别是在种族/少数民族方面 人口。今天，在NIH振兴法案20多年后的今天，增加 少数群体参与生物医学研究仍然是一个未实现的梦想，临床参与率 美国印第安人/阿拉斯加原住民(AI/AN)的试验保持在0.2%，Hisp/Lat保持在1-2%；远远低于他们的 分别占美国人口的1.0%和17.4%。如果没有足够的代表 在研究少数民族方面，我们将继续践行《不精确医学》中的研究成果 几乎只在非西班牙裔白人群体中进行的研究被外推到种族/民族 少数族裔。UA-Banner提案是亚利桑那大学和Banner之间的正式合作伙伴关系 作为西部七个州450万人的主要医疗保健提供者，包括 亚利桑那州60%的人口。我们将利用定义明确的172.5万潜在参与者池 患者在亚利桑那州、阿拉斯加州和怀俄明州的12个注册地点完成以下工作：(1)注册 150,000名志愿者，包括7,000名AI/An，90,000名Hisp/Lat和53,000名非西班牙裔白人，以及个人 将其他种族/民族纳入PMI-CP；(2)实施全面的参与者参与计划， 将参与者视为“发现的伙伴”，而不是“研究对象”；(3)使用安全和可靠的 企业数据仓库系统，用于获取、整理、识别和标准化电子健康记录，以 每季度向协调中心(CC)发送“核心数据集”，并为特殊情况提供“子组”数据集 研究；以及(4)与CC、其他HPO、参与技术中心、PMI-CP合作 生物库和指导委员会制定和实施协议和程序，执行特别 研究，获取更多的标本，增加收集的数据的数量和类型。我们的目标是 AI/AN和Hisp/Lat人群加入PMI-CP将使我们更接近总统的PMI之一 目标-通过AI/AN和An的积极参与，减少美国的种族/种族健康差距 Hisp/Lat群体在PMI-CP专项研究和新的临床试验中作为实现的必要步骤 在种族/少数民族人口中个体化治疗和量身定做的预防策略的好处。

ABSTRACT In this grant application, we propose to establish the University of Arizona Health Sciences – Banner Health (UA-Banner) Healthcare Provider Organization (HPO) Enrollment Center for the primary purpose of recruiting the large majority (50-70%) of the American Indians/Alaska Natives (AI/AN) and Hispanics/Latinos (Hisp/Lat) participants required in the NIH Precision Medicine Initiative Cohort Program (PMI-CP) which will initially enroll one million participants. The PMI-CP is a timely development that will facilitate the ability to lever advances in genomics, metabolomics, and health technologies to reduce health disparities which are contributing to excessive suffering, disability, premature death, and economic losses particularly in racial/ethnic minority populations. Today, greater than 20 years after the NIH Revitalization Act, the goal of increasing the participation of minorities in biomedical research remains an unfulfilled dream with participation rates in clinical trials remaining at 0.2% for American Indian/Alaskan Native (AI/AN) and 1-2% for Hisp/Lat; far less than their 1.0% and 17.4% representations in the U.S. population, respectively. Without adequate representation of minorities in research studies, we will continue to practice “Imprecise Medicine” in which research findings from studies conducted almost exclusively in non-Hispanic white populations are extrapolated to racial/ethnic minorities. The UA-Banner proposal is a formal partnership between the University of Arizona and Banner Health serving as the primary healthcare provider for 4.5 million individuals in seven Western States including 60% of the population of Arizona. We will utilize a well-defined potential participant pool of 1.725 million patients across 12 enrollment sites in Arizona, Alaska, and Wyoming to accomplish the following: (1) Enroll >150,000 volunteers, including 7,000 AI/AN, 90,000 Hisp/Lat and 53,000 non-Hispanic Whites, and individuals of other races/ethnicity into the PMI-CP; (2) Implement a comprehensive participant engagement plan that values the participants as “partners in discovery” rather than “research subjects”; (3) Use a secure and robust Enterprise Data Warehouse system to obtain, curate, de-identify, and normalize Electronic Health Records to transmit “core datasets” quarterly to the Coordinating Center (CC) and provide “subgroup” datasets for special studies; and (4) Collaborate with the CC, other HPOs, the participant technologies center, the PMI-CP Biobank, and the Steering Committee to develop and implement protocols and procedures, perform special studies, obtain additional specimens and increase the number and types of data collected. Our targeted enrollment of AI/AN and Hisp/Lat populations into the PMI-CP will bring us closer to one of the President's PMI goals - to reduce ethnic/racial health disparities in the U.S. through the robust participation of the AI/AN and Hisp/Lat populations in PMI-CP special research studies and novel clinical trials as a necessary step to realize the benefits of individualized therapies and tailored preventative strategies in racial/ethnic minority populations.