权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

神经科学临床试验卓越网络临床研究网站 (NeuroNEXT)

基本信息

批准号：
10593629
负责人：
MARK S QUIGG
金额：
$ 32.3万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10593629
关键词：
Adult Biological Markers Catchment Area Child Clinical Clinical Research Clinical Trials Clinical Trials Network Clinical trial protocol document Explosion Funding Future Health system Healthcare Systems Human Infrastructure International Knowledge Laboratory Finding Leadership Mentors Morbidity - disease rate Multi-Institutional Clinical Trial NCI Scholars Program Neurologic Neurology Neurosciences Outcome Patients Performance Phase Preparation Principal Investigator Process Public Health Recording of previous events Research Research Design Research Infrastructure Research Personnel Research Support Rural Rural Minority Safety Site Source Support System Training Translations United States United States National Institutes of Health Universities Virginia Work base burden of illness clinical research site design dose information effective therapy efficacy trial experience innovation medically underserved mortality multidisciplinary nervous system disorder next generation novel therapeutic intervention outreach outreach program patient population programs recruit response success

项目摘要

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.

尽管最近取得了进展，但神经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。随着神经科学中新知识的爆炸性增长，整体神经疾病负担大幅减少的可能性存在，但将新的实验室发现转化为新的人类治疗方法的工作一直滞后，部分原因是在组织、资助和执行必要的人类临床试验以证明新治疗方法的有效性方面效率低下。神经科学临床试验卓越网络(NeuroNEXT)的这次更新旨在帮助加快进行早期多中心临床试验的过程，以确定安全性和剂量信息，或验证生物标记物和临床结果，为中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NeuroNEXT站点的卓有成效和高效的过去表现，可用于进行NeuroNEXT试验的多学科临床神经学研究人员的非凡经验和专业知识，一个现有的临床推广计划，将提供接触农村少数民族和医疗服务不足的患者群体，一个全州神经学实践的推广计划，将在弗吉尼亚大学的整个流域最大限度地招募试验人员，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，以及我们稳健的历史和进一步的计划，以指导未来的临床研究人员。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Response to ibudilast treatment according to progressive multiple sclerosis disease phenotype.

DOI：
10.1002/acn3.51251
发表时间：
2021-01
期刊：
Annals of clinical and translational neurology
影响因子：
5.3
作者：
Goodman AD;Fedler JK;Yankey J;Klingner EA;Ecklund DJ;Goebel CV;Bermel RA;Chase M;Coffey CS;Klawiter EC;Naismith RT;Fox RJ;SPRINT-MS Investigators
通讯作者：
SPRINT-MS Investigators

Dynamic FDG-PET in localization of focal epilepsy: A pilot study.

局灶性癫痫定位中的动态FDG-PET：一项初步研究。

DOI：
10.1016/j.yebeh.2021.108204
发表时间：
2021-09
期刊：
Epilepsy & behavior : E&B
影响因子：
0
作者：
Seshadri V;Zarroli KA;Schetlick RS;Massey JC;Reyes JM;Eluvathingal Muttikal TJ;Patrie JT;Berr SS;Fountain NB;Kundu BK;Quigg M
通讯作者：
Quigg M

Time of day is an inaccurate surrogate marker for sleep-wake state in an epilepsy monitoring unit.

一天中的时间是癫痫监测装置中睡眠-觉醒状态的不准确替代标记。