RC2: Clinical Research Core

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的试验次数增加了四倍(达到20次)，其中大部分是阶段试验 1个评估化合物在健康老年人中的安全性和耐受性的试验和阶段2，概念验证 研究以获得关于老年患者的疗效和功能参数(例如健康跨度)的初步数据 相关疾病。OAIC成员在RC2支持下取得的主要成就包括：第一次研究 雷帕霉素在健康老年人中的应用；第一次在人体上进行的感觉剂试验；以及启动一项由美国国立卫生研究院资助的长期研究 二甲双胍用于预防虚弱的试验。RC2在OAIC学者的职业发展中发挥了关键作用 获得了享有盛誉的赠款，包括K76比森奖和退伍军人管理局职业发展奖-2。 RC2建立了一个强大的计划，以确保在临床研究中遵循良好的临床实践(GCP)。我们的 方案包括：科目招募和保留、科目登记和储存库、数据安全监测 一个老年医学实践研究网络(PBRN)和一个社区咨询委员会。RC2 提供关键的临床药理学服务以支持生物素(血浆、脑脊液、尿液、肌肉、脂肪) 收集，或测量药物水平(如二甲双胍、感冒药)，或确保安全地给药 麻醉剂给接受活组织检查的参与者。RC2为整个OAIC计划任务做出了密切贡献 与其他老年科学项目合作，包括多中心、关于感觉剂和茎的第二阶段研究 细胞激活剂(如催产素)和多中心试验，如体力活动的分子传感器 财团(MoTrPAC)、ASPREE-XT和DPPOS。RC2通过以下目标实现其使命： 1)为研究人员提供专业知识和建议，以严格规划和设计创新的临床研究 测试干预措施以改善健康状况；2)加强SA OAIC支持基础设施，以确保成功 OAIC支持的所有临床研究的受试者招募和安全合乎道德的实施；3)催化翻译 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 支持药物药代动力学、药效学分析和毒性的药理学专业知识 和安全评估；5)向公众和科学界传播关于 与老年科学相关的健康促进和翻译老年科学研究的重要性/相关性；以及 6)支持为早期教师和临床研究新手提供翻译老年科学培训。 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个具有高度创新功能的开发项目(DPS)：DP1，名为 《人-绒猴对mTOR在心脏衰老中作用的比较评估》，DP2《比较脂组学》 和DP3“临床试验衰老生物标记物的发展”。

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.”