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

• 批准号: 10468050
• 负责人: MERIT E CUDKOWICZ
• 金额: $ 239.4万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10468050
• 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

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）计划的长期目标是通过与政府、学术界、私人基金会和工业界的合作，迅速有效地将神经科学的进展转化为患有神经系统疾病的成人和儿童的治疗方法。基础神经科学的最新发现直接导致了对神经系统疾病过程的理解的重大突破，其中许多疾病给个人、家庭和社区带来了巨大的负担。然而，在多中心临床试验中测试这些新疗法存在一些组织和后勤方面的挑战，包括监管和机构审批效率低下，招募和留住研究参与者的障碍，以及缺乏经过培训并准备成为多中心临床试验领导者的个人。NeuroNEXT的中心目标是从最初的概念到最终的分析，高质量的早期临床试验和生物标志物研究，通过提供有效的方法、组织、统计和后勤支持，明确批准/不批准的决定。NeuroNEXT由25个临床站点、一个临床协调中心和一个数据协调中心组成。NeuroNEXT的创新包括建立一个需要使用中央机构审查委员会的试验网络，为所有网络资助的研究制定一个主合同流程，由单一数据安全监测委员会对所有研究进行集中安全审查，广泛共享标准操作程序和知识，最先进的早期开发试验设计方法，以及使用NINDS通用数据元素进行数据收集。寻求使用该网络的申请人可以是新手，也可以是经验丰富的试验人员，从而大大扩大了经过培训并准备领导多中心试验的经验丰富的临床研究人员的数量。在该网络的头六年里，有九项研究得到了资助，这些研究涉及与工业界、基金会、学术界和政府的合作。具体目标1是与数据协调中心密切合作，继续支持一个开放、协作的网络社区，有效地开展高质量的神经系统疾病临床试验。具体目标2是通过提供教育、培训、资源和专业指导，极大地扩大有经验的临床研究者和研究人员的数量，使他们准备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。