CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

CTSA 临床试验基础设施

• 批准号: 8364985
• 负责人: Allan R. Brasier
• 金额: $ 23.27万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8364985
• 关键词: Award; Clinical Sciences; Clinical Trials; Research Infrastructure; Translational Research

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. This application is for an ICTSA to be established at the University of Texas Medical Branch at Galveston (UTMB). Our rationale is that UTMB brings depth to the CTSA consortium, because: we are the only academic health center with both an NIAID-funded Regional Center for Excellence in Biodefense and a National Biocontainment Laboratory; we are the only center with two NIH-funded translationally oriented proteomics centers in biomarker research; we have developed translational research programs with three national laboratories (the Galveston and Sandia National Laboratories and NASA); we have trained more underrepresented minority MDs than any non-historically Black institution in the US; we have the only approved PhD-awarding Clinical Science Training program in a public university in Texas; and we have the largest telemedicine operation in the world. In response to Hurricane Ike, we have established a richer outpatient clinical research network in South East Texas. Our ICTSA are to: 1. Facilitate translational research as a rigorous discipline; 2. Develop translational research training programs at all levels in the graduate continuum; 3. Effectively conduct and bridge step 1 translational research (Tl) to steps 2 (T2) and -3 (T3); and 4. Interface productively with the national CTSA Consortium. To accomplish these goals, we have organized our ICTSA into 12 "Key Resources" ~ combinations of university core laboratories and intellectual resources, integrated by a single point of investigator/trainee contact. This structure will make us more rapidly responsive to the needs of our investigators and trainees. In this application, our Key Resources are assembled to support the translational goals of exemplar multidisciplinary translational teams (MTTs), generally organized around our successful NIH- funded interdisciplinary research centers. Three overlying principles will guide our ICTSA's operations, to: 1. Employ proactive mechanisms in identifying new team-oriented research opportunities; 2. Prioritize trainee involvement in a team-based culture; and 3. Integrate systems biological approaches into translational research. UTMB's senior leadership is providing significant new institutional resources, including establishing the Institute for Translational Sciences (ITS), our new home for translational research; new commitments of pilot grant support; administrative support; and support for a significant expansion of bioinformatics faculty. The ITS Director reports directly to UTMB's Provost, who is responsible for integration of research and education university-wide. We are thus well-positioned to achieve our goals, significantly transform clinical and translational research at UTMB, and contribute to the national CTSA Consortium. RELEVANCE (See instructions): The ICTSA will allow our researchers to more quickly and effectively translate basic science discoveries into improvements in human health. In particular this award will allow us to build teams of researchers with diverse skills who can work effectively towards a health outcome-related goal. In this way the ICTSA will break down communication, technology and regulatory barriers and transform how our university conducts patient-oriented research.

该子项目代表了 CTSA 资金百分比的估计 被用于广泛的研究领域（艾滋病研究、儿科研究或 临床试验）。 列出的总成本只是 CTSA 金额的估计值 该研究领域的基础设施，而不是直接资助 NCRR 向子项目或子项目工作人员提供的补助金。 该申请适用于在加尔维斯顿德克萨斯大学医学分校 (UTMB) 建立 ICTSA。我们的理由是 UTMB 为 CTSA 联盟带来了深度，因为： 我们是唯一一个拥有 NIAID 资助的生物防御卓越区域中心和国家生物防护实验室的学术健康中心；我们是唯一拥有两个由 NIH 资助的生物标志物研究翻译导向蛋白质组学中心的中心；我们与三个国家实验室（加尔维斯顿和桑迪亚国家实验室以及美国宇航局）合作开发了转化研究项目；我们培训的少数族裔医学博士比美国任何非历史上的黑人机构都多；我们拥有德克萨斯州公立大学唯一批准的授予博士学位的临床科学培训项目；我们拥有世界上最大的远程医疗业务。为了应对飓风艾克，我们在德克萨斯州东南部建立了更丰富的门诊临床研究网络。我们的 ICTSA 旨在： 1. 促进转化研究成为一门严格的学科； 2. 制定各级研究生的转化研究培训计划； 3. 有效地进行步骤 1 转化研究 (T1) 并将其与步骤 2 (T2) 和 -3 (T3) 连接起来； 4. 与国家 CTSA 联盟进行富有成效的沟通。为了实现这些目标，我们将 ICTSA 组织为 12 个“关键资源”——大学核心实验室和智力资源的组合，由研究者/实习生的单点联系进行整合。这种结构将使我们能够更快地响应研究人员和学员的需求。在此应用程序中，我们汇集了关键资源，以支持典型多学科转化团队 (MTT) 的转化目标，这些团队通常围绕我们成功的 NIH 资助的跨学科研究中心进行组织。三个重要原则将指导我们的 ICTSA 运作： 1. 采用积极主动的机制来识别新的以团队为导向的研究机会； 2. 优先考虑学员参与基于团队的文化； 3. 将系统生物学方法整合到转化研究中。 UTMB 的高层领导正在提供重要的新机构资源，包括建立转化科学研究所 (ITS)，这是我们转化研究的新家；试点赠款支持的新承诺；行政支持；并支持生物信息学师资队伍的大幅扩张。 ITS 主任直接向 UTMB 教务长汇报，教务长负责全校范围内研究和教育的整合。因此，我们有能力实现我们的目标，显着改变 UTMB 的临床和转化研究，并为国家 CTSA 联盟做出贡献。相关性（参见说明）：ICTSA 将使我们的研究人员能够更快、更有效地将基础科学发现转化为人类健康的改善。特别是，该奖项将使我们能够建立具有不同技能的研究人员团队，他们可以有效地实现与健康结果相关的目标。通过这种方式，ICTSA 将打破沟通、技术和监管障碍，并改变我们大学开展以患者为导向的研究的方式。