Clinical Core

临床核心

• 批准号: 10746569
• 负责人: Javier A. Neyra
• 金额: $ 30.51万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10746569
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Basic Science; Benchmarking; Big Data; Bioinformatics; Biological Specimen Banks; COVID-19; Center Core Grants; Classification; Clinical; Clinical Data; Clinical Research; Clinical Sciences; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Communication; Communities; Consultations; Data; Databases; Development; Electronic Health Record; Epidemiologic Monitoring; Epidemiology; Female; Funding; Goals; Healthcare; Heterogeneity; Human; Human Resources; Incidence; Individual; Industry; Infrastructure; Institution; Kidney; Kidney Diseases; Link; Medicine; Methodology; Methods; Outcome; Pathway interactions; Patient-Focused Outcomes; Patients; Peer Review; Peptides; Phenotype; Policies; Public Health; Publications; Registries; Research; Research Personnel; Resource Development; Resources; Risk; Risk Factors; Science; Structure; Technology; Translating; Translational Research; Translations; United States National Institutes of Health; Validation; base; biobank; bioinformatics resource; bioinformatics tool; clinical center; clinical data repository; clinical database; computing resources; data acquisition; data mining; data resource; design; digital; electronic health data; federated learning; innovation; interest; male; novel; personalized medicine; pre-clinical; preclinical evaluation; preclinical imaging; programs; response; small molecule; success; therapeutic target; tool; treatment effect

Project Summary Acute kidney injury (AKI) is a public health concern with direct impact on clinical and patient-centered outcomes, and healthcare resource utilization and policy. Recognizing the paucity of breakthrough discoveries in AKI and the growing burden of this condition, the UAB-UCSD O’Brien Clinical Core (Core A) is designed to reduce the barriers for investigators to conduct effective clinical and translational research by providing a robust infrastructure to promote collaborative projects across pre-clinical, clinical and industry researchers. Core A will provide multifaceted consultation through a customized Project Gateway, access to clinical databases, available biorepositories, and novel bioinformatics and computational technologies such as the U-BRITE and Nightingale collaborative digital workspaces in partnership with the Clinical and Translational Science Awards (CTSA) programs at both institutions for the harmonization and interrogation of big data with a focus on personalized medicine in AKI. Specifically, Core A will facilitate collaborative digital workspaces for electronic health record (EHR) data acquisition, transformation, validation, and interrogation. The overarching goal is to catalyze the translation of bench discoveries to applications that impact human AKI. The Specific Aims are structured as follows. In Aim 1, we will provide access to clinical data of patients at risk for or with AKI and consultation for their use. Specifically, we will provide access to curated clinical data from prior clinical studies hosted by Core A (Aim 1A) and provide access to new harmonized real-world data from the EHR to support epidemiological surveillance of AKI (e.g., AKI incidence, risk factors and outcomes) and novel clinical research, including but not limited to AKI risk-classification, sub-phenotyping, and simulated trials (Aim 1B). In Aim 2, we will provide access to biospecimens of patients at risk for or with AKI and consultation for their use. Specifically, we will provide access to biospecimens from prior studies hosted by Core A (Aim 2A). In Aim 2B we will provide a novel platform to link biospecimens of patients at risk for or with AKI with EHR data. Core A will have dynamic communications and collaborations with the Pre-Clinical Core, the Resource Development Core, and the O’Brien Kidney Consortium. In this U54 application, we will build upon our expertise and established successes demonstrated through our currently funded O’Brien Center P30 award. Given our commitment and expertise, we are confident that Core A will provide innovative resources to the growing research community interested in AKI-related research.

项目概要 急性肾损伤（AKI）是一个公共健康问题，直接影响临床和以患者为中心的结果， 认识到 AKI 和医疗保健资源利用和政策方面缺乏突破性发现。 随着这种情况日益严重的负担，UAB-UCSD O’Brien 临床核心（核心 A）旨在减少 通过提供强有力的证据来消除研究者进行有效的临床和转化研究的障碍 促进临床前、临床和行业研究人员合作项目的基础设施。 通过定制的项目网关提供多方面的咨询、访问临床数据库、 可用的生物存储库，以及新颖的生物信息学和计算技术，例如 U-BRITE 和 南丁格尔与临床和转化科学合作的协作数字工作空间 两个机构针对大数据的协调和审查颁发的奖项 (CTSA) 计划 具体来说，核心 A 将促进电子协作数字工作空间。 健康记录 (EHR) 数据采集、转换、验证和询问的总体目标是。 促进实验室发现转化为影响人类 AKI 的应用。 在目标 1 中，我们将提供对有 AKI 风险或患有 AKI 的患者的临床数据的访问。 具体来说，我们将提供对先前临床研究的精选临床数据的访问。 由核心 A（目标 1A）托管，并提供对 EHR 中新的统一现实世界数据的访问，以支持 AKI 的流行病学监测（例如 AKI 发病率、危险因素和结果）和新的临床研究， 包括但不限于 AKI 风险分类、亚表型分析和模拟试验（目标 1B）。 将提供有 AKI 风险或患有 AKI 的患者的生物样本，并提供其使用咨询。 我们将提供由核心 A 主持的先前研究的生物样本（目标 2A）。在目标 2B 中，我们将提供。 将有 AKI 风险或患有 AKI 的患者的生物样本与 EHR 数据联系起来的新平台将具有动态性。 与临床前核心、资源开发核心和 奥布莱恩肾脏联盟 (O’Brien Kidney Consortium) 在此 U54 申请中，我们将利用我们的专业知识和既定的成功。 鉴于我们的承诺和专业知识，我们目前资助的奥布莱恩中心 P30 奖证明了这一点。 我们相信，Core A 将为不断增长的对以下领域感兴趣的研究界提供创新资源： AKI 相关研究。