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、私人基金会和工业界的合作，迅速有效地将神经科学的进步转化为患有神经疾病的成人和儿童的治疗。最近在基础神经科学方面的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几个组织和后勤挑战，包括监管和机构批准效率低下，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的一个中心目标是通过提供有效的方法学、组织、统计和后勤支持，从最初的构思到最终分析，促进高质量的早期临床试验和具有明确通过/不通过决策的生物标记物研究。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程序、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公共数据元素进行数据收集。寻求使用该网络的申请者可以是新手或经验丰富的试验者，从而极大地扩大了训练有素并准备领导多中心试验的经验丰富的临床调查员队伍。在该网络的头六年里，资助了九项涉及与产业界、基金会、学术界和政府建立伙伴关系的研究。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，高效地进行高质量的神经疾病临床试验。具体目标2是通过提供教育、培训、资源和专业指导，极大地扩大经验丰富的临床研究人员和研究人员的队伍，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Network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.