Clinical Research Resource Core 2 (CRRC2)

PROJECT SUMMARY/ABSTRACT – CLINICAL RESEARCH RESOURCE CORE 2 The SA OAIC Clinical Research Resource Core (CRRC2) is the primary resource that supports Good Clinical Practice compliant pharmacologic trials and other clinical studies. It provides: study design and planning consultations; recruitment, tracking and retention services; standardized testing; support for pharmacokinetics/ pharmacodynamics studies; tissue sampling; safety monitoring; education; and method development. In the next cycle, the core will support clinical trials of geroscience based interventions, including new and repurposed drugs, lifestyle interventions, implementation trials, and cohort studies. All CRRC2 activities will significantly contribute to the SA OAIC theme: “Translational geroscience to improve the health and functional independence of all older adults”. The Specific Aims of the CRRC2 are: 1. Catalyze innovative clinical research by providing expertise for investigators to plan and design novel clinical trials that rigorously test geroscience interventions to improve health, function and independence. 2. Enhance the infrastructure to support recruitment, tracking, and retention of cohorts of older adults from South Texas for SA OAIC projects, OAIC Network studies, and other multisite clinical studies on aging. 3. Provide core services, including standardized health screenings, functional phenotyping, nutrition and body composition assessments, exercise testing and training, PK/PD testing, and tissue sampling. 4. Monitor and support compliance of SA OAIC studies with regulations governing clinical investigations with human subjects and ensure participant safety through our Data Safety and Monitoring Board (DSMB). 5. Provide education and training in clinical trials, recruitment, retention, and study procedures. 6. Develop and disseminate novel methods to improve recruitment and retention of all older adults from South Texas in geroscience trials. In the current cycle CRRC2 has supported first-in-human trials of seven drugs targeting the basic mechanisms of aging, as well as exercise and other behavioral interventions, and cohort studies: 13 pilot and developmental projects, 8 Scholars’ projects, and 33 external projects, including large multisite clinical trials. Over the next cycle, we will further enhance CRRC2 services to support inclusive, geroscience-focused clinical research to improve the health and functional independence of all older adults, especially in the South Texas population we serve. The CRRC2 will continue to enhance the OAIC clinical research quality, efficiency, productivity, and provide developmental opportunities for scholars and other investigators.