The University of Iowa's NeuroNEXT Clinical Research Site

爱荷华大学 NeuroNEXT 临床研究中心

• 批准号: 10407623
• 负责人: Katherine Dianne Mathews
• 金额: $ 30.26万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10407623
• 关键词: Academic Medical Centers; Adult; Age; Basic Science; Centers for Disease Control and Prevention (U.S.); Child; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Design; Clinical Trials Network; Collaborations; Communities; Community Outreach; Contracts; Disease; Education; Educational Curriculum; Epidemiologist; Faculty; Funding; Geography; Goals; Institutes; Institution; Institutional Review Boards; International; Iowa; Iowan; Lead; Leadership; Learning; Master' s Degree; Mentors; Mentorship; Methodology; Multicenter Studies; Muscular Dystrophies; National Center for Advancing Translational Sciences; National Institute of Neurological Disorders and Stroke; Nebraska; Neurology; Neuropathy; Neurosciences; Neurosciences Research; North Dakota; Pediatric Neurology; Pediatric Research; Pediatrics; Persons; Physicians; Population; Positioning Attribute; Psychiatry; Radiology Specialty; Recording of previous events; Research; Research Design; Research Institute; Research Personnel; Research Proposals; Research Training; Resources; Role; Rural Population; Site; South Dakota; Tissue Banks; Training; Training Programs; Translational Research; United States National Institutes of Health; Universities; Vocational Guidance; Work; acute stroke; career; cerebrovascular; clinical care; clinical development; clinical research site; clinically relevant; design; dystroglycanopathy; experience; geographic barrier; improved; innovation; multi-site trial; nervous system disorder; neurosurgery; outreach; outreach program; pediatric patients; programs; recruit; research and development; research study; rural setting; service programs; stroke therapy; success; training opportunity; translational scientist; translational study

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.

拟议的爱荷华大学神经科学临床试验卓越网络 (UI NeuroNEXT) 站点在临床研究领域具有长期的领导地位，具有跨部门合作和参与临床研究网络的能力。 UI NeuroNEXT 网站将利用神经内科、儿科、精神病学、神经外科、放射科、UI 临床和转化研究所以及神经科学研究所之间已有的跨学科临床研究关系。 UI NeuroNEXT 临床研究中心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）的密切领导与全州的关系，加强了对农村人口的招募；2) 临床研究和设计方面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。 UI 临床神经学项目为爱荷华州及其周边州（例如北达科他州、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，有利于继续学习。 UI 具有从地理稳定的农村环境中招募和留住患有疾病的受试者的独特能力，这些受试者跨越了潜在的 NeuroNEXT 提案的范围，这将增强 NeuroNEXT 试验的任何结果的广泛适用性。 由于 UI NeuroNEXT 网站拥有丰富的临床研究经验，与该提案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。这一经验进一步有助于在正在进行的研究中出色地招募和保留受试者。该中心的首席研究协调员和首席儿科研究协调员在管理类似于 NeuroNEXT 试验的多中心试验方面都有丰富的经验，并将为特定研究协调员提供高级领导。 NeuroNEXT 研究员的人才库将来自我们的初级教员、现任临床和研究员以及已完成 R25 研究培训计划并计划发展临床研究职业的住院医生。针对早期研究者和 NeuroNEXT 研究员的教育计划将由职业发展总监和联合 PI 领导。临床试验方法学课程是一个由 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，它将成为重要的资源。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参与 NeuroNEXT 研究的指导中学习。 UI NeuroNEXT 临床研究网站将成为 NeuroNEXT 网络的积极补充。我们将提供出色的招聘和保留服务，并参与 NeuroNEXT 委员会和教育计划。该网站将开发并提交临床研究供 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。