CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

CTSA 临床试验基础设施

• 批准号: 8173743
• 负责人: Milton Packer
• 金额: $ 112.46万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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/8173743
• 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. We propose to establish a North and Central Texas Clinical and Translational Science Initiative (NCTCTSI), which will be led by the University of Texas Southwestern Medical School at Dallas and will include many of the nation's leading schools of allopathic and osteopathic medicine, dentistry, nursing, pharmacy, public health, engineering and computer science - which have already formed a highly functional relationship supported by a Road map K12 award. We have established a Department of Clinical Sciences, which is supported by faculty from all participating schools and which will serve as the academic home for our CTSA. The Department provides academic appointments to clinical and translational investigators and to faculty whose expertise and research is focused on methodological disciplines common to all clinical research - in order to promote 'multidisciplinary team building and problem solving. The NCTCTSI will build on existing nationally- recognized programs supported by K30, M01 and Roadmap K12 awards and will integrate numerous institutional strengths to offer 12 highly innovative and fully integrated key functions: (1) building a unique academic home for clinical and translational research; (2) transforming a culture: investigator development and recognition; (3) research education, training and career development; (4) biomedical informatics; (5) stimulating novel translational ideas and methodologies; (6) support for pilot and collaborative studies; (7) research study development: design, statistics and ethics; (8) scientific review and evaluation; (9) regulatory knowledge and support; (10) participant and clinical interactions resources; (11) community engagement; and (12) translational technologies and resources. Particular strengths are: (1) a substantial financial commitment of participating institutions to the Initiative; (2) an established academic and cultural home that currently addresses many of the goals of the NIH; (3) > 200 established clinical and translational investigators who will act as faculty and mentors; (4) a highly innovative approach to integrating key functions that will act to create bonds among the members of a multidisciplinary academic community; (5) a large and medically diverse patient base cared for by internationally-renowned hospitals (which are strong supporters of this initiative); (6) > $150 million in annual peer-reviewed grant support for clinical studies; (7) superb infrastructure to support clinical and translational research; and (8) program leadership with the time, experience and commitment to ensure the success of the Initiative. The coordinated synthesis of these strengths will allow the NCTCTSI to improve the health of our community and to contribute to the national CTSA consortium and thus help to identify best practices that will benefit clinical and translational research throughout the nation.

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。 我们提议建立德克萨斯州中北部临床和转化科学计划（NCTCTSI），该计划将由达拉斯德克萨斯大学西南医学院牵头，包括许多全国领先的对抗疗法和整骨医学、牙科、护理学院、药学、公共卫生、工程和计算机科学——它们已经形成了高度功能性的关系，并得到了路线图 K12 奖项的支持。我们建立了临床科学系，该系得到所有参与学校教师的支持，并将作为我们 CTSA 的学术家园。该系向临床和转化研究人员以及专业知识和研究重点是所有临床研究共有的方法论学科的教师提供学术任命，以促进“多学科团队建设和问题解决”。 NCTCTSI 将以 K30、M01 和路线图 K12 奖项支持的现有国家认可项目为基础，整合众多机构优势，提供 12 项高度创新和完全集成的关键功能：(1) 为临床和转化研究建立独特的学术家园； (2) 转变文化：研究者的发展和认可； (3) 研究教育、培训和职业发展； (4)生物医学信息学； （5）激发新颖的翻译理念和方法； (6) 支持试点和合作研究； (7) 研究开发：设计、统计和伦理； （八）科学审查和评价； (9) 监管知识和支持； (10) 参与者和临床互动资源； (11) 社区参与； (12) 转化技术和资源。具体优势包括： (1) 参与机构对该倡议做出了实质性的财务承诺； (2) 一个已建立的学术和文化中心，目前致力于实现 NIH 的许多目标； (3) > 200 名已建立的临床和转化研究人员将担任教师和导师； (4) 采用高度创新的方法来整合关键职能，从而在多学科学术界的成员之间建立联系； (5) 由国际知名医院（该倡议的坚定支持者）提供医疗服务的庞大且医疗多样化的患者群体； (6) > 每年为临床研究提供超过 1.5 亿美元的同行评审拨款支持； (7) 支持临床和转化研究的一流基础设施； (8) 项目领导层有时间、经验和承诺，以确保该倡议的成功。这些优势的协调综合将使 NCTCTSI 能够改善我们社区的健康，并为国家 CTSA 联盟做出贡献，从而有助于确定有利于全国临床和转化研究的最佳实践。