Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

神经科学临床试验卓越临床协调中心网络

基本信息

批准号：
10213840
负责人：
MERIT E CUDKOWICZ
金额：
$ 240.23万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-30 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10213840
关键词：
Academia Adult Applications Grants Child Childhood Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Network Collaborations Common Data Element Communication Communities Community Networks Conceptions Contracts Data Data Collection Data Coordinating Center Development Disease Education Ensure Family Foundations Funding Goals Government Grant Individual Industry Institutional Review Boards Knowledge Lead Leadership Logistics Mentorship Methodology Monitor Multi-Institutional Clinical Trial Multicenter Trials National Institute of Neurological Disorders and Stroke Neurologic Neurosciences Participant Patient Recruitments Patients Population Population Decreases Population Heterogeneity Principal Investigator Privatization Procedures Process Protocols documentation Publications Reporting Research Research Design Research Personnel Resources Safety Schedule Site Small Business Innovation Research Grant Standardization Testing Time Training Training Programs Training and Education Translating Translations United States National Institutes of Health Work clinical biomarkers clinical research site cost data management early phase clinical trial early phase trial experience improved innovation investigator training nervous system disorder novel therapeutics participant retention performance site recruit stroke clinical trials success trial design

项目摘要

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 adults and children with neurological disorders through partnerships with government, academia, private foundations and industry. Recent discoveries in basic neuroscience have directly led to major breakthroughs in the understanding of disease processes in neurological disorders, many which impose an enormous burden on individuals, families and communities. Yet there are several organizational and logistical challenges to testing these new therapies in multicenter clinical trials, including inefficiencies in regulatory and institutional approvals, barriers to recruitment and retention of study participants and a dearth of individuals trained and prepared to be the leaders of multicenter clinical research 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 by providing efficient methodological, organizational, statistical and logistical support. NeuroNEXT is comprised of 25 clinical sites, a Clinical Coordinating Center and a Data Coordinating Center. NeuroNEXT innovations include establishing a trial network that requires the use of a central institutional review board, a master contract process for all network- funded studies, centralized safety review of all studies by a single Data Safety Monitoring Board, broad sharing of Standard Operating Procedures and knowledge, state-of-the-art early development trial design approaches, and the use of the NINDS common data elements for data collection. Applicants who seek to use the network can be novice or experienced trialists, thereby greatly expanding the pool of experienced clinical investigators trained and prepared to lead multicenter trials. Nine studies involving partnerships with industry, foundations, academia and the government were funded in the first six years of the network. Specific Aim 1 is to work closely with the Data Coordinating Center to continue to support an open, collaborative network community that efficiently conducts high-quality clinical trials for neurological disorders. Specific Aim 2 is to greatly expand the pool of experienced clinical Investigators and research staff who are prepared to be leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Specific Aim 3 is to continue to provide high-quality project management and regulatory coordination for all Network clinical trials.

神经科学临床试验卓越网络（NeurOnext）的长期目标是通过与政府，学术界，私人基金会和行业的伙伴关系来快速有效地将神经科学的进步转化为成人和神经系统疾病的儿童的治疗方法。基本神经科学的最新发现直接导致了对神经系统疾病的疾病过程的重大突破，许多人对个人，家庭和社区造成了巨大负担。然而，在多中心临床试验中测试这些新疗法的组织和后勤挑战，包括监管和机构批准的效率低下，招募和保留研究参与者的障碍以及对培训的个人的缺乏以及对多中心临床研究的领导者的培训和准备的人的缺乏，从而通过高级临床范围进行了概念，从而是由较高的概念进行了最初的概念，即最初的概念，是最初的概念，是最初的概念。通过提供有效的方法论，组织，统计和后勤支持，具有明确的GO/NO-GO决定的试验和生物标志物研究。 Neuronext由25个临床部位，一个临床协调中心和数据协调中心组成。 Neuronext创新包括建立一个试验网络，该网络需要使用中央机构审查委员会，所有网络资助的研究的总合同流程，单个数据安全监控委员会对所有研究的集中安全审查，标准操作程序和知识的广泛共享，最先进的早期开发试验方法以及NINDS常见数据元素用于数据元素收集。寻求使用该网络的申请人可以是新手或经验丰富的试验者，从而大大扩展了经验丰富的临床研究人员培训并准备领导多中心试验的人。在网络的头六年中，资助了涉及与行业，基金会，学术界和政府合作伙伴关系的九项研究。具体目标1是与数据协调中心紧密合作，以继续支持一个开放的协作网络社区，该社区有效地进行了高质量的神经系统疾病临床试验。具体目标2是大大扩展经验丰富的临床研究人员和研究人员，他们准备通过提供教育，培训，资源和专业指导来成为多中心临床研究试验的领导者。具体目标3是继续为所有网络临床试验提供高质量的项目管理和监管协调。