RC2: Clinical Research Core

RC2：临床研究核心

• 批准号: 10670141
• 负责人: Sara Elyse Espinoza
• 金额: $ 21.54万
• 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/10670141
• 关键词: Adipose tissue; Affect; Age; Aging; American; Award; Basic Science; Biological Markers; Biology of Aging; Biopsy; Callithrix; Capsicum; Cardiac; Cardiovascular system; Cells; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Collagen; Collection; Communities; Data; Deposition; Development; Disease; Drug Kinetics; Drug toxicity; Elastin; Elderly; Ensure; Ethics; Evaluation; FRAP1 gene; Faculty; Funding; Geriatrics; Geroscience; Goals; Good Clinical Practice; Grant; Health Promotion; Human; Informatics; Infrastructure; Intervention; K-Series Research Career Programs; Knowledge; Laboratories; Lipids; Local Anesthetics; Longevity; Magnetic Resonance Imaging; Measurement; Measures; Metformin; Mission; Molecular; Monitor; Multicenter Trials; Muscle; Myocardial dysfunction; Outcome Study; Oxytocin; Participant; Patients; Peripheral; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Phase; Physical activity; Plasma; Play; Prevention; Procedures; Process; Registries; Research; Research Design; Research Personnel; Rodent; Role; Safety; Sampling; Services; Signal Pathway; Sirolimus; Technology; Testing; Tissue Banks; Tissue Sample; Toxic effect; Training Support; Transducers; Translating; Translations; United States National Institutes of Health; Urine; Work; age effect; age related; aged; alanine aminopeptidase; career development; circulating biomarkers; comparative; data management; design; diabetes prevention program; education research; frailty; functional outcomes; healthspan; improved; innovation; lipidome; lipidomics; medication safety; member; novel; pharmacokinetics and pharmacodynamics; pharmacologic; phase 2 study; phase I trial; practice-based research network; pre-clinical research; process improvement; programs; recruit; repository; safety assessment; senescence; single-cell RNA sequencing; skills; stem cells; therapy design; trial design

The overarching goal of RC2 is to offer comprehensive, centralized, clinical trial support for study design, regulatory compliance, recruitment, retention, assessment, procedures, pharmacology, and data management. During the initial award cycle, RC2 quadrupled (to 20) its number of trials, the majority of which were phase 1 trials to evaluate safety and tolerability of compounds in healthy older adults and phase 2, proof-of-concept studies to obtain preliminary data on efficacy and functional parameters (e.g. healthspan) in patients with age- related disease. Major accomplishments made by OAIC members with RC2 support include: the first study of rapamycin in healthy older adults; the first senolytics trial in humans; and launching of an NIH-funded long-term trial of metformin for frailty prevention. RC2 played a key role in the career development of OAIC Scholars who received highly prestigious grants, including a K76 Beeson Award and a VA Career Development Award-2. RC2 has built a robust program to insure that good clinical practice (GCP) is followed in clinical studies. Our programs include: subject recruitment and retention, a subject registry and repository, a data safety monitoring board (DSMB), a Geriatrics Practice Based Research Network (PBRN), and a community advisory board. RC2 provides critical clinical pharmacology services to support biospecimen (plasma, CSF, urine, muscle, adipose) collection, or to measure levels of drugs (e.g. metformin, senolytics) or ensure safe administration of local anesthetics to participants receiving biopsies. RC2 contributed to the overall OAIC program mission by closely collaborating with other geroscience programs, including multi-center, phase 2 studies on senolytics and stem cell activators (e.g. oxytocin), and multi-center trials such as the Molecular Transducers of Physical Activity Consortium (MoTrPAC), ASPREE-XT, and DPPOS. RC2 achieves its mission through the following Aims: 1) Provide expertise and advice for investigators to plan and design innovative clinical studies to rigorously test interventions to improve healthspan; 2) Enhance the SA OAIC support infrastructure to ensure successful subject recruitment and safe and ethical conduct of all OAIC-supported clinical studies; 3) Catalyze translational human studies and trials through provision of comprehensive core services; 4) Provide analytical and clinical pharmacology expertise supporting drug pharmacokinetic, and pharmacodynamic analyses as well as toxicity and safety assessment; 5) Disseminate to the lay public and scientific community the latest research on geroscience-related health promotion and the importance/relevance of translational geroscience research; and 6) Support training in translational geroscience for early-stage faculty and those new to clinical research. In the first year of the next award cycle, RC2 plans to support 3 pilot, 3 Scholar, and 10 external projects. Additionally, RC2 will begin 3 developmental projects (DPs) with highly innovative features: DP1 entitled “Human-marmoset comparative assessment of the role of mTOR in cardiac aging”, DP2 “Comparative lipidomics of aging”, and DP3 “Development of senescence biomarkers for clinical trials.”

RC2 的总体目标是为研究设计提供全面、集中的临床试验支持， 法规遵从性、招聘、保留、评估、程序、药理学和数据管理。 在最初的授予周期中，RC2 的试验数量增加了四倍（达到 20 次），其中大部分是阶段性试验 1 项评估化合物在健康老年人中的安全性和耐受性的试验以及第 2 阶段概念验证 研究旨在获取年龄相关患者的疗效和功能参数（例如健康寿命）的初步数据 OAIC 成员在 RC2 支持下取得的主要成就包括： 第一项研究 雷帕霉素在健康老年人中的应用；首次在人体中进行 senolytics 试验；并启动了 NIH 资助的长期试验； 二甲双胍预防衰弱的试验在 OAIC 学者的职业发展中发挥了关键作用。 获得了享有盛誉的资助，包括 K76 Beeson 奖和 VA 职业发展奖 2。 RC2 建立了一个强大的计划，以确保我们的临床研究遵循良好的临床实践 (GCP)。 计划包括：受试者招募和保留、受试者注册和存储库、数据安全监控 董事会 (DSMB)、老年病学实践研究网络 (PBRN) 和社区咨询委员会 RC2。 提供关键的临床药理学服务以支持生物样本（血浆、脑脊液、尿液、肌肉、脂肪） 收集，或测量药物（例如二甲双胍、senolytics）的水平或确保局部药物的安全管理 RC2 为接受活检的参与者提供麻醉剂，为整个 OAIC 计划的使命做出了密切的贡献。 与其他老年科学项目合作，包括关于 senolytics 和 Stem 的多中心、第二阶段研究 细胞激活剂（例如催产素）和多中心试验，例如体力活动分子传感器 联盟 (MoTrPAC)、ASPREE-XT 和 DPPOS 通过以下目标实现其使命： 1) 为研究者提供专业知识和建议，以严格规划和设计创新的临床研究 测试干预措施以延长健康寿命；2) 加强 SA OAIC 支持基础设施以确保成功 3) 促进所有 OAIC 支持的临床研究的转化受试者招募以及安全和道德行为； 通过提供全面的核心服务进行人体研究和试验；4）提供分析和临床服务； 支持药物药代动力学、药效学分析以及毒性的药理学专业知识 5) 向公众和科学界传播最新研究成果 与老年科学相关的健康促进以及转化老年科学研究的重要性/相关性；以及 6) 支持对早期教师和临床研究新手进行转化老年科学培训。 在下一个奖励周期的第一年，RC2 计划支持 3 个试点项目、3 个学者项目和 10 个外部项目。 此外，RC2 将启动 3 个具有高度创新特征的开发项目 (DP)： DP1 名为 “mTOR 在心脏衰老中的作用的人类狨猴比较评估”，DP2“比较脂质组学” 衰老”和 DP3“用于临床试验的衰老生物标志物的开发”。