NSTN National Clinical Coordinating Center

描述(由申请人提供)：NINDS中风试验网络(NSTN)负责开发和测试可减轻全球中风负担的中风治疗、康复/康复和预防的新疗法。NSTN的国家协调中心(NCC)申请的总体目标是提供跨学科的领导、专业知识、创新和基础设施，以有效地启动、完成和传播第一阶段、第二阶段和第三阶段中风试验的结果，以及NSTN和NINDS领导层优先考虑的生物标记物验证研究。我们的NCC领导团队在发起、指导和完成大型多中心试验方面拥有丰富的经验。卒中PRG和NINDS最近对SPOTRIAS计划的审查认识到以卒中为导向的临床试验网络的重要性，SPOTRIAS中心之间日益增长的合作，以及为卒中恢复和预防建立类似网络的必要性。然而，在现实中，美国还没有一个有组织、有协调的中风试验方法。因此，NINDS资助的多个试验在同一机构的“同一治疗空间”内直接相互竞争，从而减缓了所有试验的招募速度。最后，整个 试验基础设施被创建，然后随着NINDS资助的每个大型第二阶段和第三阶段中风试验而被拆除；这导致了新治疗评估的极大低效和成本增加。我们对NCC和整个NSTN的具体目标是：1)创建NSTN基础设施，并在NSTN内部以及与NETT、NeuroNEXT、正在进行的NINDS资助的中风试验、CTSA、非美国中风网络和行业建立协作关系。2)促进未来五年内急性治疗、康复/康复和预防的6-8期I-III期临床试验的设计、监督和管理，并通过解决NSTN内的招募障碍，与NINDS资助的其他网络和非美国卒中网络合作，建立严格的质量控制程序来监控招募、遵守既定的最后期限和方案遵从性，以促进RCCS的整体成功，从而实现招募目标。3)与NETT和NeuroNEXT网络合作，为NSTN研究员、教师和协调员实施网络范围的教育活动和指导计划。

DESCRIPTION (provided by applicant): The NINDS Stroke Trial Network (NSTN) has been charged with the development and testing of new therapies for stroke treatment, recovery/rehabilitation, and prevention that can decrease the global burden of stroke. The overall goal of this National Coordinating Center (NCC) application for the NSTN is to provide interdisciplinary leadership, expertise, innovation, and infra-structure for the efficient initiatin, completion, and dissemination of results of Phase I, II and III stroke trials, as well as biomarker-validation studies, as prioritized by the NSTN and NINDS leadership. Our NCC leadership team has extensive experience in initiating, directing, and completing large multi-center trials. The recent Stroke PRG and NINDS review of the SPOTRIAS program recognized the importance of a stroke-oriented clinical trial network, the growing collaboration among SPOTRIAS centers, and the need for similar networks for stroke recovery and prevention. However, in reality, there has been no organized coordinated approach to stroke trials in the U.S. As result, multiple NINDS- funded trials have directly competed against one another within "the same treatment space" at the same institutions, thereby slowing recruitment for all of the trials. Finally, entire trial infrastructures have been created and then dismantled with each large NINDS-funded Phase II and Phase III stroke trial; this has resulted in enormous inefficiency and increased costs in the evaluation of new treatments. Our Specific Aims for the NCC and the entire NSTN are: 1) create the NSTN infrastructure and initiate collaborative relationships within the NSTN and with the NETT, NeuroNext, ongoing NINDS-funded stroke trials, CTSAs, non-U.S. stroke networks, and industry. 2) Facilitate the design, oversight, and management of 6-8 Phase I to III clinical trials of acute treatment, recovery/rehabilitation, and prevention within the next five yers and meet recruitment goals by addressing recruitment barriers within the NSTN, collaborating with other NINDS-funded networks and non- U.S. stroke networks, and establishing a rigorous quality control process for monitoring recruitment, adherence to established deadlines, and protocol compliance to facilitate the overall success of the RCCs. 3) Implement network-wide educational activities and mentoring programs for NSTN fellows, faculty, and coordinators in collaboration with the NETT and NeuroNext networks.