CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

CTSA 临床试验基础设施

• 批准号: 7719765
• 负责人: DAVID S GUZICK
• 金额: $ 225.7万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719765
• 关键词: Clinical Trials; Research Infrastructure

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The University of Rochester Clinical and Translational Science Institute (UR CTSI) will be created as the academic home for clinical and translational science, providing a centralized, integrated infrastructure. Under a system of governance in which the UR CTSI Program Director has authority over space, faculty, budgets, and other resources related to the CTSI, and in which much of the current GCRC budget is distributed to CTSI Key Functions in support of these functions, we plan to transform the two distinct research fields of clinical and translational science into a single new discipline. The goals of this discipline nclude the creation of new knowledge and techniques to diagnose, prevent and treat human disease, and he establishment of an environment that catalyzes their application to clinical practice in the community. To achieve these goals, we propose specific aims involving: novel methodologies; pilot studies; upgraded biomedical informatics, epidemiology, research design, ethics, and regulatory support; community engagement; new technology and resource cores; new educational and training programs; an Upstate New York Consortium; and rigorous evaluation and measurement of performance outcomes. Strategic planning for the UR CTSI has been underway for several years prior to this RFA. Evidence of institutional support includes commitment to a new 150,000 sq. ft. Clinical and Translational Science Building (CTSB) in which faculty conducting clinical and translational research will be brought together with students and trainees in existing and new degree-granting programs, with supporting regulatory and administrative functions, and with faculty working in collaborative disciplines such as biostatistics, epidemiology, and biomedical nformatics. The Director and Co-Directors of the UR CTSI will integrate the clinical and translational science functions contained in the CTSB with those functions located at other campus locations, such as functional genomics, other translational resources, and the General Clinical Research Center (GCRC). As an integral part of the CTSI, the GCRC will move into a newly-renovated 10,500 sq ft facility across the street from the CTSB, with enhanced functionality and subject access. As well, the UR CTSI will create two-way synergies with local community groups (school system, faith community, business, foundations) and with other Upstate New York institutions. Further, the UR CTSI will enable the sharing of data across disciplines and across institutions while assuring the privacy and confidentiality of human subjects. In summary, by coalescing and integrating new facilities with enhanced infrastructure, community and state-wide partnerships, a strong foundation of existing research and training, and a fundamentally reorganized administrative structure, the CTSI will transform the conduct of clinical and translational science at UR and contribute nationally to the forging of this new discipline.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 罗切斯特大学临床和转化科学研究所 (UR CTSI) 将被创建为临床和转化科学的学术家园，提供集中、综合的基础设施。 在这样的治理体系下，UR CTSI 项目主任有权管理与 CTSI 相关的空间、师资、预算和其他资源，并且当前 GCRC 的大部分预算是 为了支持这些职能，我们计划将临床和转化科学这两个不同的研究领域分配给 CTSI 关键职能，转变为一个新学科。该学科的目标包括创造新的知识和技术来诊断、预防和治疗人类疾病，并建立一个促进其应用于社区临床实践的环境。为了实现这些目标，我们提出了具体目标，包括：新颖的方法；试点研究；升级的生物医学信息学、流行病学、研究设计、伦理和监管支持；社区参与；新技术和资源核心；新的教育和培训计划；北部新区 约克财团；以及对绩效结果的严格评估和衡量。在本次 RFA 之前，UR CTSI 的战略规划已经进行了好几年。机构支持的证据包括承诺建造一座新的 150,000 平方英尺的临床和转化科学大楼 (CTSB)，其中 进行临床和转化研究的教师将与现有和新的学位授予项目的学生和实习生聚集在一起，并具有支持性的监管和行政职能，以及生物统计学、流行病学和生物医学等合作学科的教师 信息学。 UR CTSI 的主任和联合主任将把 CTSB 中包含的临床和转化科学功能与位于其他校园地点的功能整合起来，例如功能基因组学、其他转化资源和普通临床研究中心 (GCRC)。作为一个整体 作为 CTSI 的一部分，GCRC 将搬入 CTSB 街对面新装修的 10,500 平方英尺设施，该设施的功能和受试者访问均得到增强。此外，UR CTSI 将与当地社区团体（学校系统、信仰社区、企业、基金会）以及其他北部地区建立双向协同效应 纽约机构。此外，UR CTSI 将实现跨学科和跨机构的数据共享，同时确保人类受试者的隐私和机密性。总之，通过将新设施与增强的基础设施、社区和全州合作伙伴关系结合和整合，强大的 CTSI 以现有研究和培训为基础，并从根本上重组了管理结构，将改变 UR 临床和转化科学的行为方式，并为全国范围内这一新学科的建设做出贡献。