ABSTRACTIn 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 recruitingthe 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 enrollone million participants. The PMI-CP is a timely development that will facilitate the ability to lever advances ingenomics, metabolomics, and health technologies to reduce health disparities which are contributing toexcessive suffering, disability, premature death, and economic losses particularly in racial/ethnic minoritypopulations. Today, greater than 20 years after the NIH Revitalization Act, the goal of increasing theparticipation of minorities in biomedical research remains an unfulfilled dream with participation rates in clinicaltrials remaining at 0.2% for American Indian/Alaskan Native (AI/AN) and 1-2% for Hisp/Lat; far less than their1.0% and 17.4% representations in the U.S. population, respectively. Without adequate representation ofminorities in research studies, we will continue to practice ?Imprecise Medicine? in which research findings fromstudies conducted almost exclusively in non-Hispanic white populations are extrapolated to racial/ethnicminorities. The UA-Banner proposal is a formal partnership between the University of Arizona and BannerHealth serving as the primary healthcare provider for 4.5 million individuals in seven Western States including60% of the population of Arizona. We will utilize a well-defined potential participant pool of 1.725 millionpatients 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 individualsof other races/ethnicity into the PMI-CP; (2) Implement a comprehensive participant engagement plan thatvalues the participants as ?partners in discovery? rather than ?research subjects?; (3) Use a secure and robustEnterprise Data Warehouse system to obtain, curate, de-identify, and normalize Electronic Health Records totransmit ?core datasets? quarterly to the Coordinating Center (CC) and provide ?subgroup? datasets for specialstudies; and (4) Collaborate with the CC, other HPOs, the participant technologies center, the PMI-CPBiobank, and the Steering Committee to develop and implement protocols and procedures, perform specialstudies, obtain additional specimens and increase the number and types of data collected. Our targetedenrollment of AI/AN and Hisp/Lat populations into the PMI-CP will bring us closer to one of the President's PMIgoals - to reduce ethnic/racial health disparities in the U.S. through the robust participation of the AI/AN andHisp/Lat populations in PMI-CP special research studies and novel clinical trials as a necessary step to realizethe benefits of individualized therapies and tailored preventative strategies in racial/ethnic minority populations.
|Effective start/end date||7/6/16 → 6/30/21|
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