NSTN National Clinical Coordinating Center

描述（由申请人提供）：NINDS卒中试验网络（NINDS Stroke Trial Network，NINDS）负责开发和测试用于卒中治疗、恢复/康复和预防的新疗法，以减少全球卒中负担。NINDS申请国家协调中心（NCC）的总体目标是提供跨学科的领导力、专业知识、创新和基础设施，以有效启动、完成和传播NINDS和NINDS领导层优先考虑的I期、II期和III期卒中试验以及生物标志物验证研究的结果。我们的NCC领导团队在启动、指导和完成大型多中心试验方面拥有丰富的经验。最近卒中PRG和NINDS对SPOTRIAS项目的审查认识到了卒中导向临床试验网络的重要性、SPOTRIAS中心之间日益增长的合作以及对卒中恢复和预防类似网络的需求。然而，在现实中，在美国没有组织协调的中风试验方法。因此，多个NINDS资助的试验在同一机构的“相同治疗空间”内直接相互竞争，从而减缓了所有试验的招募。最后，整个 在NINDS资助的每一个大型II期和III期中风试验中，试验基础设施已经建立，然后又被拆除;这导致了新治疗方法评估中的巨大效率和成本增加。我们对NCC和整个NCLs的具体目标是：1）创建NCLs基础设施，并在NCLs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合作关系。2)在未来五年内，促进6-8项急性治疗、恢复/康复和预防的I至III期临床试验的设计、监督和管理，并通过解决NINDS内的招募障碍、与其他NINDS资助的网络和非美国卒中网络合作，以及建立严格的质量控制流程来监测招募、遵守既定的截止日期，和方案遵守情况，以促进RCC的总体成功。3)实施网络范围内的教育活动和指导计划的研究员，教师和协调员与NETT和NeuroNext网络合作。

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.