RC-2: Clinical Research Core (CRC)

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ABSTRACT – RESOURCE CORE (RC) 2 Pharmacological aging-modulating interventions that have been validated in animal models are ready to be translated into human clinical medicine. Among those interventions are the FDA-approved agents rapamycin, metformin and acarbose, thus, the time has arrived to test potential aging-modulating drugs in humans. The goal of the San Antonio Older Americans Independence Center (SA OAIC) is to advance discoveries made in animal models (invertebrates and rodents) towards relevant human trials. To support this goal, the mission of the Clinical Research Core [(henceforth dubbed Research Core 2 (RC2)] is to provide knowledge, skills, techniques, logistical, and clinical research support to foster an understanding of the functional and physiological effects of pharmacological and nutraceutical interventions on aging in older people. RC-2 capitalizes and builds upon the rich tradition and institutional support of aging research in San Antonio, as well as the dedicated commitment of our investigators to translational research, thereby ensuring the success of the Core. RC2 will provide clinical research guidance to support human trials that test interventions capable of modulating the aging process to improve and extend the healthspan and lifespan of older Americans. The Specific Aims of the Clinical Research Core are to: 1) Assist basic and clinical investigators in developing rigorous and appropriately powered clinical studies and trial concepts that will lead to innovative approaches to improve healthspan and lifespan; 2) Facilitate implementation and execution of translational human studies and clinical trials by investigators; 3) Provide expertise and coordinated access to resources and technology in both our OAIC and facilities throughout our institution to maximize the depth of phenotypic characterization relevant to aging in trial outcomes; 4) Provide training in clinical research for early-stage faculty and those new to clinical research. To achieve these aims, the RC2 Core will provide research project consultation and planning, assist with safety and regulatory compliance processes, facilitate subject recruitment and retention, and coordinate relationships with relevant OAIC Cores and other Core facilities of our institution. Importantly, RC2 will be critical to the OAIC’s goal of developing a clinical focus to conduct clinical research in geriatrics with emphasis on transformative translational research to advance discoveries from basic aging research to clinical trials and ultimately to clinical geriatrics. We will train early-career investigators, and partner with other OAICs, institutions, and the public to advance translational aging research. This Core will integrate other important OAIC core functions to ensure efficient trial design and execution, including integrating studies with the OAIC Biostatistics and Data Management Core (RC3), Research Career Development Core (RCDC), and the Pilot and Exploratory Studies Core (PESC). RC2 will work in synchrony with the Pre-Clinical Core (RC1) so that studies conducted by both cores are compatible and thereby facilitate translation into subsequent human trials.