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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的在此赠款申请中，我们建议建立亚利桑那大学健康科学 - Banner Health （UA-Banner）医疗保健提供者组织（HPO）入学中心招募主要目的美国印第安人/阿拉斯加本地人（AI/AN）和西班牙裔/拉丁美洲人（HISP/LAT）的绝大多数（50-70％） NIH Precision Medicine倡议队列计划（PMI-CP）中要求的参与者最初将注册一百万参与者。 PMI-CP是及时的发展，它将有助于利用能力基因组学，代谢组学和健康技术，以减少有助于的健康差异过度痛苦，残疾，过早死亡和经济损失，尤其是种族/族裔少数民族人群。如今，《 NIH振兴法》大于20年后，增加了少数群体参与生物医学研究仍然是一个未实现的梦想，并参与临床美国印第安人/阿拉斯加本地人（AI/AN）的试验仍为0.2％，HISP/LAT的试验仍为1-2％；远远少于他们美国人口的1.0％和17.4％的代表。没有足够的代表研究研究中的少数群体，我们将继续练习“不精确的医学”，其中的研究结果来自在非西班牙裔白人种群中几乎完全进行的研究被推断为种族/族裔少数民族。 UA-Banner提案是亚利桑那大学和横幅之间的正式合作伙伴关系在七个西方国家的450万个人，包括亚利桑那州60％的人口。我们将利用一个定义明确的潜在参与池，为172.5万亚利桑那州，阿拉斯加的12个入学地点的患者和怀俄明州以完成以下任务：（1）注册 > 150,000名志愿者，包括7,000 AI/AN，90,000 HISP/LAT和53,000个非西班牙裔白人，以及个人其他种族/民族进入PMI-CP；（2）实施一项全面的参与计划将参与者视为“发现合作伙伴”而不是“研究主题”；（3）使用安全且坚固的企业数据仓库系统以获取，策划，取消识别和将电子健康记录正常化为每季度将“核心数据集”发送到协调中心（CC），并为特殊提供“子组”数据集研究；（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，执行特殊研究，获得其他标本并增加收集的数据的数量和类型。我们的目标 AI/AN和HISP/LAT人群入学PMI-CP将使我们更接近总统的PMI之一目标 - 通过AI/AN和 PMI-CP特殊研究和新型临床试验中的HISP/LAT人群是实现的必要步骤种族/族裔少数民族人口中的个性疗法和量身定制的预防策略的好处。