Vanderbilt Site for Network of Excellence in Neuroscience Clinical Trials

范德比尔特神经科学临床试验卓越网络网站

• 批准号: 8241360
• 负责人: BETH A MALOW
• 金额: $ 31.2万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8241360
• 关键词: Adult; Child; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Commit; Data Quality; Disease; Educational Background; Enrollment; Environment; Faculty; Fostering; Foundations; Funding; Goals; Industry; Institutes; Institutional Review Boards; Internal Medicine; Leadership; Mentorship; Modeling; Multicenter Trials; National Institute of Neurological Disorders and Stroke; Neurologic; Neurosciences; Participant; Pediatric Neurology; Positioning Attribute; Principal Investigator; Psychiatry; Research; Research Infrastructure; Research Personnel; Resources; Site; Students; Training; Translating; Translational Research; United States National Institutes of Health; Universities; clinical practice; clinical research site; data integrity; experience; innovation; meetings; multidisciplinary; nervous system disorder; neurosurgery; response

DESCRIPTION (provided by applicant): Vanderbilt University is ideally positioned to be a clinical site in the Network of Excellence in Neuroscience Clinical Trials (NEXT). The Principal Investigator and her co-investigators have participated in a multitude of diverse disease-oriented networks and multicenter trials, and have a strong track record of developing and participating in innovative trials with NIH (including NINDS), industry, and foundation support. The Vanderbilt NINDS Clinical Trials team will leverage the many strengths of the collegial, multidisciplinary environment for clinical and translational research on our campus, including the Vanderbilt Institute for Clinical and Translational Research, 38 funded Cores and Centers, and rich collaborations among the departments of Neurology, Pediatrics, Neurosurgery, Psychiatry, and Internal Medicine. Our overarching goal is to establish a Vanderbilt neuroscience clinical trials network site that is uniquely positioned to translate neuroscience advances into clinical practice through the conduct of exploratory clinical trials. Our Specific Aims are: (1) To fully engage our collaborative leadership team in developing a transformative neuroscience network site that is agile and responsive to the needs of the overall NINDS Clinical Trials Network; (2) To leverage the abundant institutional resources of the Vanderbilt research enterprise-this will provide the NINDS Clinical Trials Network with deliverables including high enrollment and retention of study participants, with an emphasis on quality data and data integrity; and (3) To establish a cadre of new investigators focused on the developing and implementing neurological clinical trials. We are uniquely poised to provide mentorship and collaboration at all levels of education, including students, residents, fellows, junior faculty, and research staff. Vanderbilt is also committed to utilization of a central Institutional Review Board (IRB) model to aid in the efficiency of IRB reviews and to sharing of successful clinical trial practices with the other NINDS Clinical Trials Network sites. PUBLIC HEALTH RELEVANCE: Unprecedented opportunities exist for the treatment of a broad spectrum of neurological disorders. These are being driven by rapidly accelerating advances in neuroscience. To meet these opportunities, a coordinated network of clinical sites is needed. This network will minimize redundancy and optimize recruitment in order to rapidly implement innovative trials in response to disease-specific opportunities.

描述（由申请人提供）：范德比尔特大学是理想的定位是在神经科学临床试验卓越网络（NEXT）的临床网站。主要研究者和她的合作研究者参加了许多不同的疾病导向的网络和多中心试验，并在开发和参与NIH（包括NINDS），行业和基金会支持的创新试验方面有着良好的记录。范德比尔特NINDS临床试验团队将利用我们校园内临床和转化研究的学院，多学科环境的许多优势，包括范德比尔特临床和转化研究所，38个资助的核心和中心，以及神经病学，儿科，神经外科，精神病学和内科等部门之间的丰富合作。 我们的首要目标是建立一个范德比尔特神经科学临床试验网络网站，该网站具有独特的定位，通过开展探索性临床试验将神经科学进展转化为临床实践。我们的具体目标是：（1）让我们的合作领导团队充分参与开发一个变革性的神经科学网络网站，该网站应灵活并响应整个NINDS临床试验网络的需求;（2）利用范德比尔特研究企业丰富的机构资源-这将为NINDS临床试验网络提供可交付成果，包括高招募率和研究参与者的保留率，强调数据质量和数据完整性;（3）建立一支新的研究人员队伍，专注于开发和实施神经系统临床试验。我们是独一无二的准备在各级教育，包括学生，居民，研究员，初级教师和研究人员提供指导和合作。 范德比尔特还致力于利用中央机构审查委员会（IRB）模式，以帮助提高IRB审查的效率，并与其他NINDS临床试验网络中心分享成功的临床试验实践。 公共卫生相关性：治疗广泛的神经系统疾病存在前所未有的机会。这些都是由神经科学的快速加速发展所推动的。为了满足这些机会，需要一个协调的临床站点网络。该网络将最大限度地减少冗余并优化招募，以便针对特定疾病的机会迅速实施创新试验。