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，并且不仅在美国，而且在世界范围内都是显著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有可能大幅减少，但将新的实验室发现转化为新的人类治疗方法已经滞后，部分原因是组织，资金和执行必要的人类临床试验效率低下，以证明新治疗方法的有效性。神经科学临床试验卓越网络（NEXT）旨在帮助加快这一过程的至少一部分，特别是早期多中心临床试验的开展，以建立安全性和剂量信息，或验证生物标志物和临床结果，为中期和晚期疗效试验做准备。本申请建议将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的临床神经病学研究人员的非凡经验和专业知识，可用于进行 NEXT临床试验，一个已经存在的临床外展计划，将提供给少数民族和医疗服务不足的患者人群，一个具有全州神经病学实践的外展计划，将最大限度地提高整个弗吉尼亚联邦的试验招募，以及在弗吉尼亚大学成功执行NEXT临床试验的研究基础设施和领导计划。

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.