RC3: Study Design and Integrative Informatics Coe

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The goals of the Trial Design and Integrative Informatics Core (RC3) are to provide biostatistical collaboration and expertise, as well as centralized research information services to ensure ready access to innovative analytics and superior data quality for SA OAIC members. To further improve biostatistical analytics specifically applicable to translational geroscience, Drs. Gelfond (Core leader), Zozus (Core co-leader) and Michalek (co-investigator) will provide study and trial design guidance for OAIC investigators. They have substantial experience in developing and guiding clinical trials, solving novel biostatistical problems, and collaborating productively with OAIC-supported faculty. RC3 trial designs will rigorously assess the effects on multiple key aging phenotypes. Under Core co-leader Dr. Zozus, RC3 will use novel clinical informatics and analytic infrastructure to promote efficient trial accrual, as well as reporting and dissemination of results. This will include leveraging the electronic health record (EHR) to identify eligible subjects and providing feedback on enrollment and data collection. The Core is supported by a robust infrastructure afforded by the UTHSCSA CTSA, including an outstanding information systems team experienced in administration and production of scientific and clinical trial databases in REDCap and clinical data warehouses. This system currently supports hundreds of research projects and features rapid deployment and adaptability to geroscience-focused studies. RC3 brings these resources through these Aims: Aim 1: Trial design: Provide biostatistics and informatics support and expertise for the OAIC, including study design, power analysis, and planning; protocol development; and EHR-based feasibility analysis. Aim 2: Trial conduct, reporting, and integrated analysis: Provide OAIC clinical trials with advanced research informatics tools to support the conduct, analysis, and reporting of clinical studies. Aim 3: Training and education: Provide expertise, education, and hands-on training in the collection, management, and analysis of data in translational geroscience, and analytics mentoring for OAIC Scholars. Aim 4: Developmental projects (DPs) and novel informatics methodology: RC3 faculty will lead two highly innovative DPs: DP4, titled “Aging trial meta-analytic database (ATMDb),” will create a database of geroscience-focused clinical trials to enable the identification of promising therapeutics and aging-related biomarkers; DP5, titled “Adaptive cohort identification (ACI),” aims to develop predictive algorithms for rapid identification of cohorts that both meet trial criteria and are likely to enroll efficiently. In addition to DP4 and DP5, during FY1 of the next funding period RC3 will provide biostatistical and medical informatics support to 5 pilot, 5 Scholar, 5 external, and 3 additional DPs. RC3 also will continue to assist the national OAIC program and the broader scientific community through development, dissemination, and implementation of novel multi-center trial approaches relevant to translational geroscience.