CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

CTSA 临床试验基础设施

• 批准号: 7719806
• 负责人: Milton Packer
• 金额: $ 107.28万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719806
• 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. 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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 我们建议建立德克萨斯州北部和中部临床和转化科学倡议(NCTCTSI)，该倡议将由达拉斯的德克萨斯大学西南医学院领导，将包括许多全国领先的对抗和骨科医学、牙科、护理、药学、公共卫生、工程和计算机科学--这些学校已经形成了高度有效的关系，并得到了路线图K12奖的支持。我们已经建立了一个临床科学系，它得到了所有参与学校的教职员工的支持，将作为我们CTSA的学术之家。为了促进多学科团队建设和问题解决，该部门为临床和转化性研究人员以及其专业知识和研究集中于所有临床研究共同的方法学学科的教职员工提供学术任命。NCTCTSI将建立在K30、M01和Roadmap K12奖项支持的现有国家认可计划的基础上，并将整合众多机构优势，提供12项高度创新和完全集成的关键功能：(1)为临床和翻译研究建立一个独特的学术家园；(2)转变文化：研究人员的发展和认可；(3)研究教育、培训和职业发展；(4)生物医学信息学；(5)激励创新的翻译想法和方法；(6)支持试点和合作研究；(7)研究研究发展：设计、统计和伦理；(8)科学审查和评估；(9)监管知识和支持；(10)参与者和临床互动资源；(11)社区参与；以及(12)翻译技术和资源。具体优势是：(1)参与机构对该倡议的大量财政承诺；(2)一个成熟的学术和文化之家，目前满足了NIH的许多目标；(3)&GT；200名成熟的临床和翻译研究人员，他们将担任教员和导师；(4)整合关键职能的高度创新方法，将在多学科学术社区的成员之间建立联系；(5)由国际知名医院(这是该倡议的强烈支持者)护理的大型和医疗多样化的患者基础；(6)&GT；每年为临床研究提供1.5亿美元的同行评审赠款支持；(7)支持临床和转化性研究的一流基础设施；(8)具有时间、经验和承诺的计划领导力，以确保该计划的成功。这些优势的协调综合将使NCTCTSI能够改善我们社区的健康，并为全国CTSA联盟做出贡献，从而帮助确定将有利于全国临床和转化研究的最佳实践。