Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) DCC

神经科学临床试验卓越网络 (NeuroNEXT) DCC

基本信息

批准号：
10744965
负责人：
CHRISTOPHER S. COFFEY
金额：
$ 195.97万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10744965
关键词：
Adult Affect Age Applications Grants Area Biometry Childhood Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Network Collaborations Common Data Element Communication Communication Tools Community Networks Conceptions Data Data Collection Data Coordinating Center Data Security Development Discipline Disease Education Ensure Evaluation Foundations Funding Future Gene Targeting Goals Industry Information Technology Infrastructure Iowa Lead Leadership Methodology Monitor Multicenter Trials National Institute of Neurological Disorders and Stroke Neurologic Neurosciences Participant Patients Persons Population Positioning Attribute Principal Investigator Process Protocols documentation Publications Randomized Reporting Request for Applications Research Research Design Research Personnel Safety Science Secure Site Standardization System Therapeutic Traineeship Training Programs Training and Education Translating Translations United States Universities Work clinical biomarkers clinical research site cognitive disability data management data quality data sharing design disability distributed data early phase clinical trial early phase trial experience gene therapy graduate student improved innovation mortality nervous system disorder operation participant enrollment physically handicapped quality assurance success targeted treatment tool trial design web platform

项目摘要

PROJECT SUMMARY/ABSTRACT The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for neurological disorders. There are over 1000 different neurological disorders, many of which are associated with significant cognitive and physical disabilities. In the United States, neurological diseases affect over 100 million people of all ages, and they are a significant cause of mortality and disability. While therapeutic options are currently limited or non-existent for many of these disorders, recent exciting advances in the neurosciences and in gene therapies for neurological disorders make it imperative to increase the ability to efficiently perform clinical trials. A central goal of NeuroNEXT is to facilitate, from initial conception through final analysis, high-quality early phase clinical trials and biomarker studies with clear go/no-go decisions in adult and pediatric neurological disorders. This application requests funds for the University of Iowa to continue serving as the DCC for NeuroNEXT. The DCC will continue to support study design, data collection, data management, data sharing, project management, clinical site monitoring, quality management, safety monitoring, and all statistical aspects of trials conducted within the network. The DCC will continue to build on our robust, standardized, and accessible infrastructure in a manner that is explicitly designed to accommodate dynamically changing requirements that naturally occur in clinical trials, and will continue to help NeuroNEXT succeed in providing more rapid evaluations of promising treatments in the neurosciences. Specific Aim 1 is to work closely with the CCC to continue to support a collaborative network community that efficiently solicits and conducts high-quality clinical trials for neurological disorders. Specific Aim 2 is to continue to provide high-quality IT/development, data management, statistical, and protocol coordination support for all network clinical trials. Specific Aim 3 is to expand the pool of experienced clinical Investigators, research staff, and biostatisticians who are prepared to be leaders of multicenter clinical research trials.

项目摘要/摘要神经科学临床试验卓越网络（Neuronext）倡议的长期目标是将神经科学的进步迅速转化为神经系统疾病的治疗方法。有超过1000种不同的神经系统疾病，其中许多与严重的认知和身体残疾有关。在美国，神经疾病影响了所有年龄段的超过1亿人，这是死亡率和残疾的重要原因。尽管目前许多这些疾病的治疗选择是有限的或不存在的，但神经科学和神经系统疾病基因疗法的最新进展使得必须提高有效进行临床试验的能力。 Neuronext的一个核心目标是从最初的概念到最终分析，高质量的早期临床试验和生物标志物研究，并在成人和小儿神经系统疾病中进行明确的GO/NO-GO决定。该申请要求爱荷华大学继续担任Neuronext的DCC。 DCC将继续支持研究设计，数据收集，数据管理，数据共享，项目管理，临床站点监控，质量管理，安全监控以及网络内进行试验的所有统计方面。 DCC将继续以我们的健壮，标准化和可访问的基础设施为基础，以明确设计的方式，以适应临床试验中自然发生的动态变化需求，并将继续帮助Neuronext成功地为神经科学中有前途的治疗提供更快的评估。具体目标1是与CCC紧密合作，以继续支持一个协作网络社区，该社区有效地征求并进行神经系统疾病的高质量临床试验。具体目标2是继续为所有网络临床试验提供高质量的IT/开发，数据管理，统计和协议协调支持。具体目标3是扩大准备成为多中心临床研究试验领导者的经验丰富的临床研究人员，研究人员和生物统计学家的库。