Vanderbilt Site for Network of Excellence in Neuroscience Clinical Trials

描述（由申请人提供）：范德比尔特大学的理想定位是成为神经科学临床试验卓越网络（NEXT）的临床站点。首席研究员和她的合作研究者参与了许多不同的疾病导向网络和多中心试验，并在NIH（包括NINDS）、行业和基金会的支持下开发和参与创新试验方面有着良好的记录。范德比尔特大学NINDS临床试验团队将利用大学多学科环境的诸多优势，在我们的校园进行临床和转化研究，包括范德比尔特大学临床和转化研究所，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范德比尔特神经科学临床试验网站，该网站具有独特的定位，可以通过探索性临床试验将神经科学的进步转化为临床实践。我们的具体目标是：(1)充分参与我们的合作领导团队开发一个变革性的神经科学网络站点，该站点敏捷且响应整个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，包括高入学率和研究参与者的保留，重点是数据质量和数据完整性；(3)建立一支新的研究骨干队伍，专注于开展和实施神经学临床试验。我们是独一无二的准备，提供指导和合作，各级教育，包括学生，居民，研究员，初级教师和研究人员。Vanderbilt还致力于利用中央机构审查委员会（IRB）模式来帮助提高IRB审查的效率，并与其他NINDS临床试验网络站点分享成功的临床试验实践。

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.