The University of Iowa's NeuroNEXT Clinical Research Site

拟议的爱荷华大学神经科学临床试验卓越网络(UI NeuroNEXT)网站在临床研究方面有着长期的领导地位，跨部门合作和参与临床研究网络。伊利诺伊大学NeuroNEXT网站将利用神经科、儿科、精神科、神经外科、放射科、伊利诺伊州大学临床和翻译研究所以及神经科学倡议研究所之间已经建立的跨学科临床研究关系。UI NeuroNEXT临床研究地点建议的独特之处在于1)神经科和儿科(儿童神经病学部)的密切领导与全州各地的关系，加强了从农村人口中招聘的人员；2)临床研究和设计方面的经验丰富的导师和教育工作者，包括医生、生物统计学家和流行病学家。爱荷华州立大学临床神经学项目为爱荷华州及周边州(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。种群相当稳定，便于在研究中保留。UI独特的能力，可以从地理稳定的农村环境中招募和留住患有各种潜在NeuroNEXT建议的疾病受试者，这将增强NeuroNEXT试验结果的广泛适用性。由于UI NeuroNEXT网站拥有丰富的临床研究经验，与这项建议相关的研究协调员在神经科学临床试验方面拥有多年的经验。这一经验还有助于在正在进行的研究中出色地招募和保留受试者。该网站的首席研究协调员和首席儿科研究协调员都在管理类似于NeuroNEXT试验的多站点试验方面经验丰富，并将为特定研究协调员提供高级领导。NeuroNEXT研究员将来自我们的初级教员、目前的临床和研究研究员以及已完成R25研究培训计划并计划发展临床研究事业的住院医生。针对早期调查人员和NeuroNEXT研究员的教育计划将由职业提升总监和共同绩效指标共同领导。临床试验方法学课程将是一个重要的资源，这是一个由NIH资助的国家培训课程，用于制定研究提案，并由该提案的一名PI领导。另一个为研究员提供的资源包括UI ICTS临床研究课程，该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在NeuroNEXT研究中的指导参与中学习。UI NeuroNEXT临床研究网站将是NeuroNEXT网络的积极补充。我们将提供优秀的招聘和留住服务，并参与NeuroNEXT委员会和教育活动。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的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.