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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 我们建议建立一项北部和中部得克萨斯州的临床和转化科学倡议（NCTCTSI），该计划将由达克萨斯大学西南医学院的西南医学院领导，并将包括许多全国领先的同种疗法和骨质疗法，牙科医学，牙科医学，牙科，护理，医疗，药物，公共卫生，工程学和计算机科学的高度支持 - 由功能相关联，该公司的功能是由功能相关的。我们已经建立了一个临床科学系，该系由所有参与学校的教师提供支持，并将作为我们CTSA的学术住所。该部门为临床和转化调查人员以及教师提供了学术任命，其专业知识和研究侧重于所有临床研究的方法学学科，以促进“多学科团队建设和解决问题”。 NCTCTSI将基于由K30，M01和Roadmap K12奖支持的现有全国认可的计划，并将整合众多的机构优势，以提供12个高度创新且完全集成的关键功能：（1）为临床和翻译研究建立独特的学术住所； （2）改变一种文化：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）刺激新颖的翻译思想和方法论； （6）支持试点和协作研究； （7）研究开发：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； （12）翻译技术和资源。特定的优势是：（1）参与机构对该计划的实质性财务承诺； （2）既定的学术和文化住宅，目前涉及NIH的许多目标； （3）> 200名临床和转化调查人员将担任教师和导师； （4）一种集成关键功能的高度创新方法，该方法将在多学科学术界成员之间建立纽带； （5）由国际知名的医院（这是该计划的强有力的支持者）所照顾的大型且医学多元化的患者基础； （6）> 1.5亿美元的年度同行评审赠款支持临床研究； （7）支持临床和转化研究的精湛基础设施； （8）以时间，经验和承诺来确保倡议成功的计划领导力。这些优势的协调综合将使NCTCTSI能够改善我们社区的健康状况，并为国家CTSA财团做出贡献，从而有助于确定最佳实践，从而使全国各地的临床和转化研究受益。