New York Stroke Trials Network of Columbia and Cornell (NYCCSTN)

描述(由申请人提供)：哥伦比亚大学和康奈尔大学的纽约中风试验网络(NYSTNCC)将建立，目标是最大限度地扩大我们地区的中风临床试验登记人数。分别位于曼哈顿西侧和东侧的哥伦比亚和康奈尔将形成两个枢纽，由布鲁克林和新泽西的3家医院组成的额外急性治疗子网络以及由韦斯特切斯特县和新泽西的3个附属学术康复中心组成的恢复子网络提供支持。我们的中心在中风临床试验中拥有广泛的领先记录。仅在过去的5年里，哥伦比亚大学和康奈尔大学就参与了44项人类中风研究，包括29项中风临床试验，10项中风生物标记物研究，以及5项中风结果研究。在枢纽和子网络站点目前活跃的中风研究中，已有1200多名患者入选。每个子网络站点都有临床试验经验，以及中风临床试验登记的跟踪记录，使他们能够在网络运行后立即开始实施试验。我们的16家附属医院将形成环境转诊网络。我们网络中的总体人口结构非常有利于招收服务不足的少数族裔：哥伦比亚大学40%的西班牙裔和25%的非裔美国人；康奈尔大学15%的亚裔；圣约瑟夫大学24%的非裔美国人，30%的西班牙裔，12%的其他人。在每个主要领域--急性治疗、预防和康复--的三个创新的第二阶段临床试验以及一个儿科中风项目被提出。该网络将包括来自神经学、神经外科、放射学、急诊医学、介入神经放射学和康复医学的合作研究人员，他们拥有广泛的与中风相关的高水平专业知识。为了最大限度地扩大每个地点的登记人数，我们将在前6个月举行每月一次的会议，培训地点协调员了解我们的监测和登记方法，包括如何协商EMR系统，如何接近中风患者，代孕登记使用的语言，以及如何确保准确的数据输入。我们还将通过视频会议举行季度研究更新会议，其中将包括枢纽、子网络站点和转诊医院。我们的基础科学家将支持临床 通过帮助产生新提案的想法，并为国家一级提出的新项目提供基础科学背景，进行了一系列的试验。哥伦比亚大学和康奈尔大学的基础和临床科学高级教员将指导初级教员，并每年培训一名血管神经学研究员。我们建议继续马歇尔博士通过我们的SPOTRIAS赠款发起的非常成功的每月网络研讨会系列，我们希望在国家一级实施这一系列活动。

DESCRIPTION (provided by applicant): The New York Stroke Trials Network of Columbia and Cornell (NYSTNCC) will be established with the goal of maximizing stroke clinical trial enrollment for our region. Columbia and Cornell, situated on the west and east side of Manhattan, respectively, will form the two hubs, supported by an additional Acute Treatment Sub-network of 3 hospitals in Brooklyn and New Jersey --and a Recovery Sub-network comprising 3 affiliated academic Rehabilitation Centers in Westchester County and New Jersey. Our hubs have an extensive leadership record in stroke clinical trials. Columbia and Cornell have been involved in 44 human stroke studies in the last 5 years alone, including 29 stroke clinical trials, 10 stroke biomarker studies, and 5 stroke outcomes studies. Of the currently active stroke studies at hubs and sub-network sites, over 1,200 patients have been enrolled. Each sub-network site has clinical trials experience, and a track record of stroke clinical trial enrollment, enabling them to start implementing trials as soon as the Network is operational. Our 16 affiliated Hospitals will form a referral network for the environment. The demographics in our network overall are very favorable for enrolling underserved minority populations: Columbia 40% Hispanic and 25% African American; Cornell 15% Asian, and St. Joseph's 24% African American, 30% Hispanic, 12% other. Three innovative phase-2 clinical trials in each of the cardinal areas - acute treatment, prevention, and recovery - are proposed, along with a pediatric stroke project. The Network will include co-investigators from Neurology, Neurosurgery, Radiology, Emergency Medicine, Interventional Neuroradiology and Rehabilitation Medicine with a wide range of high-level stroke-related expertise. To maximize enrollment at each site, we will hold monthly sessions in the first 6 months to train site coordinators on our surveillance and enrollment methods, including how to negotiate EMR systems, how to approach patients with stroke deficits, language to use for surrogate enrollment, and how to ensure accurate data entry. We will also hold quarterly research update meetings by videoconference that will include the hubs, sub-network sites, and referral hospitals. Our basic scientists will support the clinical trials by helping to generate ideas for new proposals and by providing basic science context for new projects being proposed at the national level. Basic and clinical science senior faculty at Columbia and Cornell will mentor junior faculty and train one Vascular Neurology Research Fellow per year. We propose to continue the highly successful monthly Webinar series that Dr. Marshall initiated through our SPOTRIAS grant, which we hope to implement at the national level.