CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

CTSA 临床试验基础设施

• 批准号: 8173797
• 负责人: Pamela B Davis
• 金额: $ 428.07万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8173797
• 关键词: Clinical Trials; Research Infrastructure

This subproject represents an estimate of the percentage of the CTSA funding that is being utilized for a broad area of research (AIDS research, pediatric research, or clinical trials). The Total Cost listed is only an estimate of the amount of CTSA infrastructure going towards this area of research, not direct funding provided by the NCRR grant to the subproject or subproject staff. Translational and clinical research are the crowning glories of biomedical research, but the infrastructure for this research has not received appropriate attention. In the Case Western Reserve University/Cleveland Clinic CTSA (the CTSA) we will coordinate existing resources relevant to clinical research at Case Western Reserve University and three of its hospital affiliates, the Cleveland Clinic, MetroHealth Medical Center, and University Hospitals Case Medical Center, including three existing GGRC facilities, a successful multidisciplinary institutional K12 program, substantial technological and statistical core facilities that currently exist in silos, and our famous practice-based research networks. In addition, we will create new resources, including community partnership resources, a new coordinated bioinformatics infrastructure, a new M.D-Ph.D. program in clinical research, and coordinated resources in bioethics and regulatory support. An academic home for clinical research, the Center for Clinical Investigation, directed by the CTSA PI and Interim Dean of the Case School of Medicine, will provide the career development support necessary for clinical investigators. When it is fully operational, the CTSA will offer research participant resources that span the range of support for technology-intensive studies that require the resource of the Academic Medical Centers, to local practices, to the Cleveland community itself. The community, both organizations and individuals, will be engaged in a dialogue about patient-based research. These participant resources will be supported by technologic cores, methodologic development, and an infrastructure of biomedical informatics. Permeating the entire enterprise is an educational program, directed by the CTSA Co-Pi, that takes full advantage of not only our institutional educational prowess, but also the CTSA clinical research resources. CTSA resources will be easily accessed either online or in person through a Clinical Research Concierge, which will assure prospective input into proposals by statistics and design experts, ethicists:and regulatory experts, and any other expertise that the project requires. Streamlining of operations and coordination of resources, set against a backdrop and track record of strong cooperation among the CTSA partners, will lead to efficient use of scarce resources and maximal support of clinical research in the city of Cleveland, which ultimately will benefit our citizens and the health of all Americans.

本分项目是CTSA供资的估计百分比，即 被用于广泛的研究领域(艾滋病研究、儿科研究或 临床试验)。列出的总成本仅是对CTSA金额的估计 用于这一研究领域的基础设施，而不是由 授予子项目或子项目工作人员的NCRR补助金。 翻译和临床研究是生物医学研究的至高无上的荣耀，但这项研究的基础设施没有得到适当的重视。在凯斯西部储备大学/克利夫兰诊所CTSA(The CTSA)中，我们将协调凯斯西部储备大学及其三家附属医院(克利夫兰诊所、MetroHealth医疗中心和大学医院案例医疗中心)与临床研究相关的现有资源，包括三个现有的GGRC设施、一个成功的多学科机构K12项目、目前存在于竖井中的大量技术和统计核心设施，以及我们著名的实践研究网络。此外，我们将创建新的资源，包括社区伙伴关系资源、新的协调生物信息学基础设施、新的临床研究医学博士项目，以及生物伦理和监管支持方面的协调资源。临床研究中心是临床研究的学术之家，由CTSA Pi和凯斯医学院临时院长指导，将为临床研究人员提供必要的职业发展支持。当CTSA完全投入使用时，CTSA将为需要学术医学中心资源的技术密集型研究提供研究参与者资源，并向克利夫兰社区本身提供本地实践。社区，包括组织和个人，将参与关于以患者为基础的研究的对话。这些参与者的资源将得到技术核心、方法开发和生物医学信息学基础设施的支持。贯穿整个企业的是一个由CTSA Co-Pi指导的教育项目，它不仅充分利用了我们的机构教育实力，而且还充分利用了CTSA的临床研究资源。CTSA资源将通过临床研究礼宾在线或亲自访问，这将确保对统计和设计专家、伦理学家和监管专家的提案以及该项目所需的任何其他专业知识的预期投入。在CTSA合作伙伴之间强有力合作的背景和记录下，简化运营和资源协调将导致克利夫兰市有效利用稀缺资源和最大限度地支持临床研究，最终将造福于我们的公民和所有美国人的健康。