The University of Iowa's NeuroNEXT Clinical Research Site

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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.