Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

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、私人基金会和行业的合作，快速有效地将神经科学的进步转化为治疗患有神经系统疾病的成人和儿童。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理解的重大突破，其中许多神经系统疾病给个人、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、招募和保留研究参与者的障碍以及缺乏经过培训和准备成为多中心临床研究试验领导者的个人。 NeuroNEXT 的中心目标是通过提供有效的方法、组织、统计和后勤支持，促进从最初构思到最终分析的高质量早期临床试验和生物标志物研究，并做出明确的进行/不进行决策。 NeuroNEXT 由 25 个临床中心、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、所有网络资助研究的主合同流程、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、标准操作程序和知识的广泛共享、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者，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库。该网络成立的头六年内资助了九项涉及工业界、基金会、学术界和政府合作的研究。 具体目标 1 是与数据协调中心密切合作，继续支持开放、协作的网络社区，有效地进行神经系统疾病的高质量临床试验。 具体目标 2 是通过提供教育、培训、资源和专业指导，大幅扩大经验丰富的临床研究者和研究人员的队伍，让他们做好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。

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.