The University of Iowa's NeuroNEXT Clinical Research Site

拟议中的爱荷华大学神经科学临床试验卓越网络（UI NeuroNEXT）网站在跨部门合作和参与临床研究网络的临床研究方面具有悠久的领导历史。UI NeuroNEXT网站将利用神经病学、儿科、精神病学、神经外科、放射科、UI临床与转化研究所和神经科学倡议研究所之间已经存在的跨学科临床研究关系。UI NeuroNEXT临床研究站点提案的独特之处在于：1)神经病学和儿科（儿童神经病学部门）的密切领导与全州关系的结合，加强了农村人口的招聘；2)临床研究和设计方面经验丰富的导师和教育家，包括医生、生物统计学家和流行病学家。UI临床神经学项目为爱荷华州和周边州（如北达科他州、南达科他州和内布拉斯加州）的人们提供服务。人口相当稳定，有利于学生的学习。UI具有独特的能力，可以从地理稳定的农村环境中招募和保留具有潜在NeuroNEXT建议范围的疾病受试者，这将增强NeuroNEXT试验结果的广泛适用性。由于UI NeuroNEXT网站具有丰富的临床研究经验，因此与该提案相关的研究协调员具有多年的神经科学临床试验经验。这种经验进一步有助于在正在进行的研究中出色地招聘和保留科目。该中心的首席研究协调员和首席儿科研究协调员都具有管理类似于NeuroNEXT试验的多中心试验的经验，并将为特定的研究协调员提供高级领导。NeuroNEXT的研究员将来自我们的初级教师，目前的临床和研究人员以及已经完成R25研究培训计划并计划发展临床研究事业的住院医生。早期研究人员和NeuroNEXT研究员的教育计划将由职业提升总监和共同pi领导。临床试验方法学课程将是一个重要的资源，该课程是由美国国立卫生研究院资助的培训课程，用于制定研究提案，并由该提案的一位pi领导。研究员的另一个资源包括UI ICTS临床研究课程，可以获得硕士学位。NeuroNEXT研究员和其他临床研究人员也将从他们的指导下参与NeuroNEXT研究中学习。UI NeuroNEXT临床研究站点将成为NeuroNEXT网络的积极补充。我们将提供优秀的招聘和保留，并参与NeuroNEXT委员会和教育计划。该网站将开发和提交临床研究供NeuroNEXT网络考虑，并将努力通过教育机会增加成功临床研究人员的数量。

The proposed University of Iowa Network for Excellence in Neuroscience Clinical Trials (UI NeuroNEXT) site has a long-standing history of leadership in clinical research with cross-departmental collaboration and involvement in clinical research networks. The UI NeuroNEXT site will capitalize on the interdisciplinary clinical research relationships already in place between the departments of Neurology, Pediatrics, Psychiatry, Neurosurgery, Radiology, the UI Institute of Clinical and Translational Research and the Institute for Neuroscience Initiatives. Unique to the UI NeuroNEXT clinical research site proposal is 1) the combined close leadership from the Departments of Neurology and Pediatrics (Child Neurology Division) with relationships across the state that enhance recruitment from a rural population and 2) experienced mentors and educators in clinical research and design including physicians, biostatisticians, and epidemiologists. The UI clinical neurology program services people across the state of Iowa and from surrounding states (e.g. North Dakota, South Dakota, and Nebraska). The population is quite stable, facilitating retention in studies. The UI’s unique ability to recruit and retain subjects with disease that span the range of potential NeuroNEXT proposals from a geographically stable, rural setting will enhance the broad applicability of any results from NeuroNEXT trials. As a result of the UI NeuroNEXT site’s extensive clinical research experience, the research coordinators associated with this proposal have many years of experience in neuroscience clinical trials. This experience further contributes to the excellent recruitment and retention of subjects in ongoing studies. The lead research coordinator and the lead pediatric research coordinator for this site are both experienced in management of multi-site trials similar to NeuroNEXT trials and will provide senior leadership for specific study coordinators. The pool for NeuroNEXT fellows will come from our junior faculty, current clinical and research fellows and residents who have completed the R25 research training program and are planning to develop a clinical research career. The education initiatives for early investigators and for the NeuroNEXT fellow will be led by the Career Enhancement Director, along with the co-PIs. The Clinical Trials Methodology Course, a national NIH funded training course for developing research proposals and led by one of the PIs for this proposal, will be an important resource. Another resource for fellows includes the UI ICTS clinical research curriculum that can lead to a Masters degree. NeuroNEXT fellows and other clinician researchers will also learn from their mentored involvement in NeuroNEXT studies. The UI NeuroNEXT clinical research site will be an active addition to the NeuroNEXT network. We will offer excellent recruitment and retention, and participate in NeuroNEXT committees and education initiatives. The Site will develop and submit clinical studies for consideration by the NeuroNEXT network and will work to increase the number of successful clinical researchers through educational opportunities.