RC3: Study Design and Integrative Informatics Coe

试验设计和综合信息学核心(RC3)的目标是提供生物统计合作 和专业知识，以及集中的研究信息服务，以确保随时获取创新分析 为SA OAIC成员提供卓越的数据质量。进一步改进特别适用的生物统计分析 对于翻译型老年科学，Gelfond博士(核心负责人)、Zozus博士(核心联合负责人)和Michalek博士(联合研究员) 将为OAIC调查人员提供研究和试验设计指导。他们在以下方面有丰富的经验 开发和指导临床试验，解决新的生物统计学问题，并与 OAIC支持的教职员工。 RC3试验设计将严格评估对多种关键衰老表型的影响。在核心联席领导下 Zozus博士，RC3将使用新的临床信息学和分析基础设施来促进有效的试验收益，如 以及报告和传播成果。这将包括利用电子健康记录(EHR)来 确定符合条件的科目，并提供关于注册和数据收集的反馈。核心由一个 UTHSCSA CTSA提供强大的基础设施，包括一支出色的信息系统团队 有管理和制作RedCap和临床数据的科学和临床试验数据库的经验 仓库。该系统目前支持数百个研究项目，并具有快速部署和 适应以老年科学为重点的研究。RC3通过以下目标提供这些资源： 目标1：试验设计：为OAIC提供生物统计学和信息学支持和专业知识，包括研究 设计、电源分析和规划；协议开发；以及基于电子病历的可行性分析。 目标2：试验实施、报告和综合分析：为OAIC临床试验提供先进的 研究信息学工具，以支持临床研究的进行、分析和报告。 目标3：培训和教育：提供收藏方面的专业知识、教育和实践培训， 翻译老年科学中的数据管理和分析，以及为OAIC学者提供分析指导。 目标4：发展项目(DPS)和新的信息学方法论：RC3学院将领导两个高度 创新的DPS：DP4，标题为“老龄化试验元分析数据库(ATMDb)”，将创建一个 以老年科学为重点的临床试验，能够确定有前景的治疗方法和与衰老相关的 DP5，名为“自适应队列识别(ACI)”，旨在开发快速预测算法 确定既符合试验标准又可能有效登记的队列。 除DP4和DP5外，在下一个供资期间的第一财年，RC3将提供生物统计和医疗 为5名飞行员、5名学者、5名外部人员和3名额外的DPS提供信息支持。RC3亦会继续协助 国家OAIC计划和更广泛的科学界通过开发、传播和 实施与翻译老年学相关的新的多中心试验方法。

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.