Clinical Research Core

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Although some improvement has been seen between initiation of the Oklahoma Shared Clinical and Translational Resources (OSCTR) and today (moving from 49th to 46th in rankings), Oklahoma is consistently in or near the bottom 10% of states for the overall health of its population. The residents of the state disproportionately suffer from chronic health problems, such as obesity, diabetes, cardiovascular disease, and arthritis/autoimmunity. Oklahomans have a life-expectancy which is 3 years shorter than the average US citizen and American Indians have a life-expectancy which is 7.3 years shorter than other groups within the US. With high percentages of rural (38%) and tribal (9%) populations, Oklahoma has unique challenges and opportunities to implement clinical and translational research (CTR) projects and dissemination and implementation research to improve health and health care. The Clinical Resources (CR) Core of the OSCTR has built a centralized system to support human subjects research in the state that has prioritized its focus on these issues. The Core provides clinical research facilities and a CAP-certified Biorepository that has allowed the OSCTR to adopt or establish registries, repositories, and cohorts to assist investigators to obtain and utilize high-quality samples to support their research efforts. This effort has allowed the Core to provide more than 95,000 clinical samples and more than 1.6 million data fields in the first four years of the award. This support has launched the careers of multiple CTR investigators, including researchers that are members of the under- represented minority communities in the state. The CR Core will continue to provide this invaluable access to sample collections while supporting the establishment of new repositories focusing on the health issues of greatest concerns to our populations, including cancer, diabetes and osteoarthritis. The CR core is also expanding the capabilities of its Clinical Research Units by new innovative partnerships with the Oklahoma Blood Institute and Oklahoma City Veterans Affairs Medical Center. This will enhance the overall opportunities of our CTR investigators to recruit participants into research studies as well as provide new capabilities to translate research findings and effect population health through partners that interact with a large number of previously unreached Oklahoma residents. Through the CR Core, the OSCTR is establishing a formal Regulatory Assistance Unit to provide a centralized location for OSCTR Investigators to seek assistance with institutional IRB applications, protocols, data safety monitoring boards and other regulatory requirements. This Unit will work with the Administrative Core to make access to resources and information more accessible to investigators, clinicians, clinical research staff and participants through the new Gateway to Oklahoma portal. This unit will work closely with the OSCTR Tribal Engagement Unit to help investigators to work with the Indian Health Service and tribal IRBs ensure the protection of both individual human subjects and tribal community populations.