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

亚利桑那大学 - 横幅健康精准医学计划队列招生中心

• 批准号: 9525183
• 负责人: USHA MENON
• 金额: $ 479.63万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-08 至 2018-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9525183
• 关键词: Acute; Alaska; Alaska Native; Ambulatory Care; American Indians; Applications Grants; Arizona; Behavioral; Biomedical Research; Caring; Cessation of life; Clinic; Clinical Trials; Country; Data; Data Collection; Data Set; Development; Disadvantaged; Disease; Disease Management; Dreams; Economics; Effectiveness; Electronic Health Record; Enrollment; Ensure; Ethnic Origin; Ethnic group; Family; Genetic study; Genomics; Goals; Health; Health Personnel; Health Sciences; Health Technology; Healthcare; Hispanics; Hospitals; Individual; Institution; Latino; Lead; Medicine; Minority; Minority Participation; Molecular; Not Hispanic or Latino; PMI cohort; Participant; Patients; Physicians; Play; Population; Population Group; Prevention approach; Prevention strategy; Primary Health Care; Procedures; Protocols documentation; Race; Recruitment Activity; Research; Research Subjects; Resources; Role; Scientist; Secure; Short Interspersed Nucleotide Elements; Site; Specimen; Subgroup; System; Technology; Testing; Time; United States National Institutes of Health; Universities; Work; Wyoming; adverse outcome; biobank; cohort; college; design; disability; disorder prevention; ethnic health disparity; ethnic minority population; health disparity; high risk population; individualized medicine; metabolomics; novel; novel therapeutics; precision medicine; premature; programs; racial and ethnic; racial health disparity; racial minority; research study; response; volunteer; working group

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.

抽象的 在此拨款申请中，我们建议建立亚利桑那大学健康科学学院 - Banner Health （UA-横幅）医疗保健提供者组织 (HPO) 注册中心，主要目的是招募 绝大多数 (50-70%) 美洲印第安人/阿拉斯加原住民 (AI/AN) 和西班牙裔/拉丁裔 (Hisp/Lat) NIH 精准医学倡议队列计划 (PMI-CP) 所需的参与者，该计划最初将招募 一百万参与者。 PMI-CP 是一个及时的发展，将促进利用先进技术的能力 基因组学、代谢组学和健康技术，以减少健康差距，从而促进 过度痛苦、残疾、过早死亡和经济损失，特别是少数种族/族裔 人口。今天，在 NIH 振兴法案颁布 20 多年后，增加 少数族裔参与生物医学研究仍然是一个未实现的梦想，临床参与率 美洲印第安人/阿拉斯加原住民 (AI/AN) 的试验保持在 0.2%，Hisp/Lat 的试验保持在 1-2%；远远低于他们的 在美国人口中分别占 1.0% 和 17.4%。如果没有足够的代表性 在研究中，我们将继续实践“不精确医学”，其中研究结果 几乎完全在非西班牙裔白人群体中进行的研究被推断为种族/民族 少数民族。 UA-Banner 提案是亚利桑那大学和 Banner 之间的正式合作伙伴关系 Health 是七个西部州 450 万人的主要医疗保健提供者，其中包括 占亚利桑那州人口的60%。我们将利用 172.5 万名明确的潜在参与者池 亚利桑那州、阿拉斯加和怀俄明州 12 个登记点的患者完成以下任务：(1) 登记 >150,000 名志愿者，包括 7,000 名 AI/AN、90,000 名西班牙裔/拉丁裔和 53,000 名非西班牙裔白人和个人 将其他种族/族裔纳入 PMI-CP； (2) 实施全面的参与者参与计划 将参与者视为“发现的合作伙伴”而不是“研究对象”； (3) 使用安全、稳健的 企业数据仓库系统，用于获取、整理、去识别化和规范化电子健康记录，以 每季度向协调中心（CC）传输“核心数据集”，并为特殊情况提供“分组”数据集 研究； (4) 与 CC、其他 HPO、参与者技术中心、PMI-CP 合作 生物样本库和指导委员会制定和实施协议和程​​序，执行特别 研究、获取更多标本并增加收集数据的数量和类型。我们的目标 将 AI/AN 和 Hisp/Lat 人群纳入 PMI-CP 将使我们更接近总统的 PMI 之一 目标 - 通过 AI/AN 的积极参与，减少美国的民族/种族健康差异 PMI-CP 特殊研究和新颖临床试验中的 Hisp/Lat 人群是实现这一目标的必要步骤 个性化治疗和量身定制的预防策略对少数种族/族裔人群的益处。