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脑卒中试验网络（NYSTNCC）将以最大限度地提高我们地区脑卒中临床试验的入组率为目标建立。分别位于曼哈顿西侧和东侧的哥伦比亚大学和康奈尔大学将形成两个中心，由布鲁克林和新泽西的三家医院组成的额外急性治疗子网络以及由威斯特彻斯特县和新泽西的三家附属学术康复中心组成的康复子网络提供支持。我们的中心在中风临床试验方面有着广泛的领导记录。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项中风生物标志物研究和5项中风结果研究。目前在中心和子网络站点进行的卒中研究中，已有1200多名患者入组。每个子网络站点都有临床试验经验，并有卒中临床试验登记的跟踪记录，使它们能够在网络运行后立即开始实施试验。我们的16家附属医院将形成一个环境转诊网络。我们网络的人口统计数据总体上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%的非洲裔美国人；康奈尔15%是亚裔，圣约瑟夫24%是非裔，30%西班牙裔，12%其他族裔。在每个主要领域——急性治疗、预防和康复——提出了三个创新的2期临床试验，以及一个儿科中风项目。该网络将包括来自神经病学、神经外科、放射学、急诊医学、介入神经放射学和康复医学的联合研究人员，他们具有广泛的高水平卒中相关专业知识。为了最大限度地提高每个站点的入组率，我们将在前6个月内每月举行一次会议，培训站点协调员了解我们的监测和入组方法，包括如何协商电子病历系统，如何处理卒中缺陷患者，替代入组时使用的语言，以及如何确保准确的数据输入。我们还将通过视频会议召开季度研究更新会议，包括中心、子网络站点和转诊医院。我们的基础科学家将支持临床研究

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.