Clinical Research Site for the Network of Excellence in Neuroscience Clin. Trials

描述（由申请人提供）：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重大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。神经科学临床试验卓越网络（NEXT）被提议帮助加速这一过程的至少一部分，特别是进行早期多中心临床试验，以建立安全性和剂量信息，或验证生物标志物和临床结果，为中期和后期的疗效试验做准备。本应用程序建议弗吉尼亚大学卫生系统作为NEXT网络的临床站点。该提案描述了一个多学科临床神经学研究骨干的非凡经验和专业知识

DESCRIPTION (provided by applicant): 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. The Network for Excellence in Neuroscience Clinical Trials (NEXT) is proposed to help expedite at least part of this process, specifically 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 as a Clinical Site for the NEXT network. The proposal describes the extraordinary experience and expertise of a multi-disciplinary cadre of clinical neurological investigators available to conduct NEXT clinical trials, an already existing clinical outreach program that will afford access to rura minority and medically underserved patient populations, an outreach program with statewide neurology practices that will maximize trial recruitment throughout the Commonwealth of Virginia, and the research infrastructure and leadership plan for successfully executing NEXT clinical trials at the University of Virginia.