RC2: Clinical Research Core

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The overarching goal of RC2 is to offer comprehensive, centralized, clinical trial support for study design, regulatory compliance, recruitment, retention, assessment, procedures, pharmacology, and data management. During the initial award cycle, RC2 quadrupled (to 20) its number of trials, the majority of which were phase 1 trials to evaluate safety and tolerability of compounds in healthy older adults and phase 2, proof-of-concept studies to obtain preliminary data on efficacy and functional parameters (e.g. healthspan) in patients with age- related disease. Major accomplishments made by OAIC members with RC2 support include: the first study of rapamycin in healthy older adults; the first senolytics trial in humans; and launching of an NIH-funded long-term trial of metformin for frailty prevention. RC2 played a key role in the career development of OAIC Scholars who received highly prestigious grants, including a K76 Beeson Award and a VA Career Development Award-2. RC2 has built a robust program to insure that good clinical practice (GCP) is followed in clinical studies. Our programs include: subject recruitment and retention, a subject registry and repository, a data safety monitoring board (DSMB), a Geriatrics Practice Based Research Network (PBRN), and a community advisory board. RC2 provides critical clinical pharmacology services to support biospecimen (plasma, CSF, urine, muscle, adipose) collection, or to measure levels of drugs (e.g. metformin, senolytics) or ensure safe administration of local anesthetics to participants receiving biopsies. RC2 contributed to the overall OAIC program mission by closely collaborating with other geroscience programs, including multi-center, phase 2 studies on senolytics and stem cell activators (e.g. oxytocin), and multi-center trials such as the Molecular Transducers of Physical Activity Consortium (MoTrPAC), ASPREE-XT, and DPPOS. RC2 achieves its mission through the following Aims: 1) Provide expertise and advice for investigators to plan and design innovative clinical studies to rigorously test interventions to improve healthspan; 2) Enhance the SA OAIC support infrastructure to ensure successful subject recruitment and safe and ethical conduct of all OAIC-supported clinical studies; 3) Catalyze translational human studies and trials through provision of comprehensive core services; 4) Provide analytical and clinical pharmacology expertise supporting drug pharmacokinetic, and pharmacodynamic analyses as well as toxicity and safety assessment; 5) Disseminate to the lay public and scientific community the latest research on geroscience-related health promotion and the importance/relevance of translational geroscience research; and 6) Support training in translational geroscience for early-stage faculty and those new to clinical research. In the first year of the next award cycle, RC2 plans to support 3 pilot, 3 Scholar, and 10 external projects. Additionally, RC2 will begin 3 developmental projects (DPs) with highly innovative features: DP1 entitled “Human-marmoset comparative assessment of the role of mTOR in cardiac aging”, DP2 “Comparative lipidomics of aging”, and DP3 “Development of senescence biomarkers for clinical trials.”