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

描述（由申请人提供）：将建立哥伦比亚和康奈尔的纽约卒中试验网络（NYSTNCC），目标是最大限度地增加我们地区的卒中临床试验入组人数。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中心，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康复子网络提供支持。我们的中心在中风临床试验方面拥有广泛的领导记录。哥伦比亚大学和康奈尔大学仅在过去5年就参与了44项人类卒中研究，包括29项卒中临床试验、10项卒中生物标志物研究和5项卒中结局研究。在中心和子网络研究中心目前正在进行的卒中研究中，已招募了1，200多名患者。每个子网络站点都有临床试验经验和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家附属医院将形成一个环境转诊网络。我们网络中的人口统计数据总体上非常有利于招收服务不足的少数民族人口：哥伦比亚40%的西班牙裔和25%的非洲裔美国人;康奈尔15%的亚洲人，圣约瑟夫24%的非洲裔美国人，30%的西班牙裔，12%的其他人。三个创新的2期临床试验在每个主要领域-急性治疗，预防和恢复-提出了沿着一个儿科中风项目。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共同研究者，他们具有广泛的高水平中风相关专业知识。为了最大限度地增加每家临床试验机构的入组人数，我们将在前6个月内每月举行一次会议，对临床试验机构协调员进行关于我们的监测和入组方法的培训，包括如何协商EMR系统、如何接触有卒中缺陷的患者、用于替代入组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，会议将包括中心、子网络站点和转诊医院。我们的基础科学家将支持临床 通过帮助为新的建议提供思路，并为国家一级提出的新项目提供基础科学背景，来进行试验。哥伦比亚和康奈尔大学的基础和临床科学高级教师将指导初级教师，并每年培训一名血管神经病学研究员。我们建议继续开展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。

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.