RC3: Study Design and Integrative Informatics Coe

RC3：研究设计和综合信息学中心

• 批准号: 10221558
• 负责人: Jonathan Adam Letterman Gelfond
• 金额: $ 23.02万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-15 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10221558
• 关键词: Aging; American; Automation; Biological Markers; Biometry; Capsicum; Clinical Informatics; Clinical Research; Clinical Trials; Clinical Trials Database; Clinical Trials Design; Collaborations; Collection; Communities; Data; Data Analyses; Data Collection; Databases; Development; Dissemination and Implementation; Education; Electronic Health Record; Enrollment; Ensure; Equilibrium; Faculty; Feedback; Funding; Geroscience; Goals; HRK gene; Health Sciences; Informatics; Information Dissemination; Information Services; Information Systems; Information Technology; Infrastructure; Lead; Medical Informatics; Mentors; Meta-Analysis; Methodology; Multicenter Trials; Participant; Phase I Clinical Trials; Phenotype; Population; Production; Publishing; Randomized; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Sample Size; Sampling; Scheme; Services; System; Testing; Therapeutic; Training; Training and Education; Translations; age related; base; biomarker performance; clinical data warehouse; clinical predictors; cohort; data quality; data sharing; design; experience; faculty support; improved; informatics tool; innovation; insight; interest; machine learning method; member; novel; population health; power analysis; pre-clinical; prediction algorithm; primary endpoint; programs; protocol development; response; response biomarker; trial design; web site; web-accessible

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.

试验设计和综合信息学核心（RC 3）的目标是提供生物统计学协作 和专业知识，以及集中的研究信息服务，以确保随时获得创新的分析 和上级数据质量。为了进一步改进生物统计分析， Gelfond博士（核心负责人）、Zozus博士（核心共同负责人）和Michalek博士（共同研究者） 将为OAIC研究者提供研究和试验设计指导。他们有丰富的经验， 开发和指导临床试验，解决新的生物统计问题，并与 OAIC支持的教师。 RC 3试验设计将严格评估对多种关键衰老表型的影响。Under Core共同领导人 博士Zozus，RC 3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累积， 以及成果的报告和传播。这将包括利用电子健康记录（EHR）， 确定合格受试者并提供入组和数据收集反馈。核心由一个 由UTHSCSA CTSA提供的强大基础设施，包括一支出色的信息系统团队 在管理和制作REDCap和临床数据中的科学和临床试验数据库方面经验丰富 仓库该系统目前支持数百个研究项目，具有快速部署和 适应以老年科学为重点的研究。RC 3通过这些目标带来这些资源： 目的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、功率分析和规划;协议开发;以及基于EHR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，以支持临床研究的开展、分析和报告。 目标3：培训和教育：提供收集方面的专门知识、教育和实践培训， 管理和分析转化老年科学的数据，并为OAIC学者提供分析指导。 目标4：发展项目（DP）和新的信息学方法：RC 3教师将领导两个高度 创新的DP：DP 4，题为“老化试验荟萃分析数据库（ATMDb）”，将创建一个数据库， 以老年科学为重点的临床试验，以确定有前途的治疗方法和与衰老有关的 生物标志物; DP 5，题为“自适应队列识别（ACI）”，旨在开发预测算法， 确定既符合试验标准又可能有效入组的队列。 除了DP 4和DP 5之外，在下一个供资期的FY 1期间，RC 3将提供生物统计和医疗服务。 为5名试点人员、5名学者、5名外部人员和3名额外的发展伙伴提供信息学支助。RC 3还将继续协助 国家OAIC计划和更广泛的科学界通过开发，传播， 实施与转化老年科学相关的新型多中心试验方法。