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，不仅在美国，而且在世界范围内都是严重发病率和死亡率的来源。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大幅减少的可能性是存在的，但将新的实验室发现转化为新的人类治疗方法的部分原因是组织、资金和执行必要的人类临床试验以证明新治疗方法的有效性的效率低下。此次神经科学临床试验卓越网络（NeuroNEXT）的更新旨在帮助加快开展早期多中心临床试验的过程，以确定安全性和剂量信息，或验证生物标志物和临床结果，为中期和后期疗效试验做准备。本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一个NeuroNEXT站点的有效和高效的过去表现，一个多学科临床神经学研究骨干的非凡经验和专业知识，可以进行NeuroNEXT试验，一个已经存在的临床推广项目，将为农村少数民族和医疗服务不足的患者群体提供服务。与全州神经病学实践的推广计划，将在弗吉尼亚大学的整个集水区最大限度地招募试验人员，研究基础设施和领导计划，成功地在弗吉尼亚大学执行NeuroNEXT临床试验，以及我们强大的历史和进一步的计划，以指导未来的临床研究人员。

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.