RC2: Clinical Research Core

RC2：临床研究核心

• 批准号: 10455768
• 负责人: Sara Elyse Espinoza
• 金额: $ 21.93万
• 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/10455768
• 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; Collagen; Collection; Communities; Data; Deposition; Development; Disease; Drug toxicity; Elastin; Elderly; Ensure; Ethics; Evaluation; FRAP1 gene; Faculty; Funding; Geriatrics; Geroscience; Goals; Gold; 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; Medication Management; Metformin; Mission; Molecular; Monitor; Multicenter Trials; Muscle; Myocardial dysfunction; Outcome Study; Oxytocin; Participant; Patients; Peripheral; Pharmaceutical Preparations; 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; phase 2 study; phase I trial; practice-based research network; pre-clinical research; 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的，集中的，临床试验支持， 监管合规，招聘，保留，评估，程序，药理学和数据管理。 在最初的奖励周期中，RC2四倍（至20个）试验次数，其中大多数是阶段 1个试验，以评估健康老年人和第2阶段的化合物的安全性和耐受性，概念验证证明 研究以获取有关年龄患者的效率和功能参数的初步数据 相关疾病。 RC2支持的OAIC成员取得的重大成就包括： 健康老年人的雷帕霉素；人类的第一次塞溶术审判；并启动了NIH资助的长期 二甲双胍预防脆弱的试验。 RC2在OAIC学者的职业发展中起着关键作用 获得了高度著名的赠款，包括K76 Beeson奖和VA职业发展奖2。 RC2建立了一个强大的计划，以确保临床研究中遵循良好的临床实践（GCP）。我们的 计划包括：主题招聘和保留，主题注册表和存储库，数据安全监控 董事会（DSMB），基于老年医学实践的研究网络（PBRN）和社区顾问委员会。 RC2 提供关键的临床药理学服务来支持生物赛车（等离子体，CSF，尿液，肌肉，脂肪） 收集或测量药物的水平（例如二甲双胍，塞溶剂剂）或确保当地的安全管理 对参加活检的参与者进行麻醉。 RC2紧密地为整个OAIC计划任务做出了贡献 与其他GEROSCIENCE计划合作，包括多中心，第二阶段有关Senolotics和STEM的研究 细胞激活剂（例如催产素）和多中心试验，例如体育活动的分子换能器 财团（motrpac），aspree-xt和dppos。 RC2通过以下目标实现了其使命： 1）为调查人员提供专业知识和建议，以计划和设计创新的临床研究 测试干预措施以改善健康状态； 2）增强SA OAIC支持基础设施以确保成功 所有OAIC支持的临床研究的受试者招募以及安全和道德行为； 3）催化翻译 通过提供综合核心服务的人类研究和试验； 4）提供分析和临床 支持药代动力学和药效分析的药理学专业知识以及毒性 和安全评估； 5）向外行公共和科学界传播有关的最新研究 与Geroscience相关的健康促进以及转化性Geroscience研究的重要性/相关性；和 6）支持早期教师的转化性Geroscience培训和临床研究的新教师。 在下一个奖励周期的第一年，RC2计划支持3个飞行员，3个学者和10个外部项目。 此外，RC2将开始3个具有高度创新功能的开发项目（DPS）：DP1 “ MTOR在心脏衰老中的作用的人类武器比较评估”，DP2“比较脂质瘤 衰老”和DP3“临床试验的感应生物标志物的开发”。