RC-2: Clinical Research Core (CRC)

RC-2：临床研究核心 (CRC)

• 批准号: 9277345
• 负责人: Tyler J. Curiel
• 金额: $ 9.28万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9277345
• 关键词: Acarbose; Aging; Aging-Related Process; American; Animal Model; Animals; Biological Process; Biology of Aging; Biometry; Callithrix jacchus jacchus; Capsicum; Clinic; Clinical; Clinical Investigator; Clinical Medicine; Clinical Pharmacology; Clinical Research; Clinical Trials; Consultations; Core Facility; Discipline; Disease; Endocrinology; Ensure; FDA approved; Faculty; Female; Fostering; Funding; Geriatrics; Gerontology; Goals; Health Sciences; Human; Institution; Intervention; Invertebrates; Knowledge; Lead; Life; Logistics; Longevity; Mammals; Metformin; Mission; Modeling; Mus; Nutraceutical; Outcome; Pharmaceutical Preparations; Pharmacology; Phenotype; Physiological; Physiology; Process; Recording of previous events; Recruitment Activity; Research; Research Personnel; Research Project Grants; Research Support; Resources; Rodent; Safety; Science; Sirolimus; Structure; Technical Expertise; Techniques; Technology; Testing; Texas; Time; Training; Translating; Translational Research; Translations; Transplant Recipients; Universities; Work; age related; cancer type; career; career development; data management; healthy aging; improved; innovation; laboratory facility; male; neuropsychiatry; nonhuman primate; oncology; pre-clinical; programs; skills; success; therapy development; trial design

ABSTRACT – RESOURCE CORE (RC) 2 Pharmacological aging-modulating interventions that have been validated in animal models are ready to be translated into human clinical medicine. Among those interventions are the FDA-approved agents rapamycin, metformin and acarbose, thus, the time has arrived to test potential aging-modulating drugs in humans. The goal of the San Antonio Older Americans Independence Center (SA OAIC) is to advance discoveries made in animal models (invertebrates and rodents) towards relevant human trials. To support this goal, the mission of the Clinical Research Core [(henceforth dubbed Research Core 2 (RC2)] is to provide knowledge, skills, techniques, logistical, and clinical research support to foster an understanding of the functional and physiological effects of pharmacological and nutraceutical interventions on aging in older people. RC-2 capitalizes and builds upon the rich tradition and institutional support of aging research in San Antonio, as well as the dedicated commitment of our investigators to translational research, thereby ensuring the success of the Core. RC2 will provide clinical research guidance to support human trials that test interventions capable of modulating the aging process to improve and extend the healthspan and lifespan of older Americans. The Specific Aims of the Clinical Research Core are to: 1) Assist basic and clinical investigators in developing rigorous and appropriately powered clinical studies and trial concepts that will lead to innovative approaches to improve healthspan and lifespan; 2) Facilitate implementation and execution of translational human studies and clinical trials by investigators; 3) Provide expertise and coordinated access to resources and technology in both our OAIC and facilities throughout our institution to maximize the depth of phenotypic characterization relevant to aging in trial outcomes; 4) Provide training in clinical research for early-stage faculty and those new to clinical research. To achieve these aims, the RC2 Core will provide research project consultation and planning, assist with safety and regulatory compliance processes, facilitate subject recruitment and retention, and coordinate relationships with relevant OAIC Cores and other Core facilities of our institution. Importantly, RC2 will be critical to the OAIC’s goal of developing a clinical focus to conduct clinical research in geriatrics with emphasis on transformative translational research to advance discoveries from basic aging research to clinical trials and ultimately to clinical geriatrics. We will train early-career investigators, and partner with other OAICs, institutions, and the public to advance translational aging research. This Core will integrate other important OAIC core functions to ensure efficient trial design and execution, including integrating studies with the OAIC Biostatistics and Data Management Core (RC3), Research Career Development Core (RCDC), and the Pilot and Exploratory Studies Core (PESC). RC2 will work in synchrony with the Pre-Clinical Core (RC1) so that studies conducted by both cores are compatible and thereby facilitate translation into subsequent human trials.

摘要-资源核心（RC）2 已经在动物模型中得到验证的药理学衰老调节干预措施已经准备就绪， 转化为人类临床医学。这些干预措施包括FDA批准的药物雷帕霉素， 二甲双胍和阿卡波糖，因此，现在是时候在人类中测试潜在的衰老调节药物了。的 圣安东尼奥老年美国人独立中心（SA OAIC）的目标是推动在 动物模型（无脊椎动物和啮齿动物）用于相关的人体试验。为了支持这一目标，使命 临床研究核心[（以下称为研究核心2（RC 2）]的目的是提供知识， 技能，技术，后勤和临床研究支持，以促进对功能的理解 药物和保健品干预对老年人衰老的生理影响。 RC-2利用并建立在圣安东尼奥老龄化研究的丰富传统和机构支持的基础上， 以及我们的研究人员致力于转化研究，从而确保 核心的成功。RC 2将提供临床研究指导，以支持测试干预措施的人体试验 能够调节衰老过程，以改善和延长老年人的健康和寿命 美国人临床研究核心的具体目标是：1）协助基础和临床研究者 在开发严谨和适当的临床研究和试验概念，将导致创新 改善健康寿命和寿命的方法; 2）促进翻译的实施和执行 研究人员进行的人体研究和临床试验; 3）提供专业知识和协调的资源访问 和技术在我们的OAIC和设施在我们的机构，以最大限度地深度表型 与试验结果中的老化相关的表征; 4）为早期阶段的临床研究提供培训 教师和那些新的临床研究。为了实现这些目标，RC 2核心将提供研究项目， 咨询和规划，协助安全和监管合规流程，促进受试者 招聘和保留，并协调与相关OAIC核心和其他核心设施的关系， 我们的机构重要的是，RC 2将对OAIC制定临床重点的目标至关重要， 老年医学的临床研究，重点是变革性的转化研究，以促进发现 从基础老龄化研究到临床试验，最终到临床老年医学。我们将在职业生涯早期进行培训 研究人员，并与其他OAIC，机构和公众合作，以推进平移老化 research.该核心将整合审咨委其他重要核心职能，以确保有效的试验设计， 执行，包括将研究与OAIC生物统计和数据管理核心（RC 3）整合， 研究职业发展核心（RCDC）和试点和探索性研究核心（PESC）。RC 2将 与临床前核心（RC 1）同步工作，以便两个核心进行的研究兼容 从而便于转化为后续的人体试验。