Clinical Research Site for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT)

尽管最近取得了进展，但神经系统疾病仍然是一个主要的公共卫生问题，并且不仅在美国而且在全世界都是重大发病率和死亡率的根源。随着神经科学新知识的爆炸式增长，整体神经系统疾病负担有可能大幅减轻，但将新的实验室发现转化为新的人类治疗方法却滞后，部分原因是证明新治疗方法有效性所需的人体临床试验的组织、资助和执行效率低下。此次神经科学临床试验卓越网络 (NeuroNEXT) 的更新旨在帮助加快早期多中心临床试验的进行过程，以建立安全性和剂量信息，或验证生物标志物和临床结果，为中后期疗效试验做准备。该申请建议将弗吉尼亚大学卫生系统更新为 NeuroNEXT 网络的临床站点。该提案描述了弗吉尼亚大学作为 NeuroNEXT 站点的过去有效和高效的表现、可用于进行 NeuroNEXT 试验的多学科临床神经学研究人员队伍的非凡经验和专业知识、现有的临床外展计划，该计划将为农村少数族裔和医疗服务不足的患者群体提供机会、一项具有全州神经病学实践的外展计划，该计划将最大限度地扩大整个弗吉尼亚大学学区的试验招募、在弗吉尼亚大学成功执行 NeuroNEXT 临床试验的研究基础设施和领导计划，以及我们悠久的历史和指导未来临床研究人员的进一步计划。

Despite recent advances, neurological diseases continue to be a major public health problem and are the source of significant morbidity and mortality not only in the United States, but world-wide. With the explosion of new knowledge in the neurosciences, the possibility of dramatic reductions in the overall neurological disease burden exists, but translation of new laboratory findings into new human treatments has lagged partially due to inefficiencies in the organization, funding, and execution of the necessary human clinical trials to prove the efficacy of new therapeutic approaches. This renewal for the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) is proposed to help expedite the process of the conduct of early phase multi-center clinical trials to establish safety and dose information or to validate biomarkers and clinical outcomes in preparation for middle and late phase trials of efficacy. This application proposes the University of Virginia Health System be renewed as a Clinical Site for the NeuroNEXT network. The proposal describes the effective and efficient past performance of the University of Virginia as a NeuroNEXT site, the extraordinary experience and expertise of a multi-disciplinary cadre of clinical neurological investigators available to conduct NeuroNEXT trials, an already existing clinical outreach program that will afford access to rural minority and medically underserved patient populations, an outreach program with statewide neurology practices that will maximize trial recruitment throughout the catchment of the University of Virginia, the research infrastructure and leadership plan for successfully executing NeuroNEXT clinical trials at the University of Virginia, and our robust history and further plans to mentor future clinical researchers.