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

哥伦比亚和康奈尔大学纽约中风试验网络 (NYCCSTN)

• 批准号: 8897185
• 负责人: Randolph S Marshall
• 金额: $ 39.1万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8897185
• 关键词: Academic Medical Centers; Acute; African American; Area; Asians; Basic Science; Biological Markers; Blood Vessels; Cause of Death; Childhood stroke; Clinical; Clinical Sciences; Clinical Trials; County; Data; Development; Educational Curriculum; Emergency Medicine; Enrollment; Ensure; Environment; Faculty; Goals; Grant; Healthcare Systems; Hispanics; Hospital Referrals; Hospitals; Human; Language Disorders; Leadership; Marshal; Mediation; Mentors; Methods; National Institute of Neurological Disorders and Stroke; Neurologist; Neurology; Neurosciences; New Jersey; New York; Outcome Study; Patients; Phase; Phase II Clinical Trials; Physical Medicine; Population; Populations at Risk; Presbyterian Church; Prevalence; Prevention; Principal Investigator; Radiology Specialty; Recovery; Rehabilitation Centers; Research; Research Personnel; Science; Scientist; Series; Side; Site; Stroke; Stroke Volume; Stroke prevention; System; Teacher Professional Development; Training; Underrepresented Minority; Update; Videoconferences; Videoconferencing; acute stroke; aging population; demographics; design; disability; experience; innovation; medical schools; meetings; mortality; neurosurgery; next generation; novel; public health relevance; stroke recovery; tool; treatment center; trend

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.

描述（由申请人提供）：将建立哥伦比亚和康奈尔（NYSTNCC）的纽约中风试验网络，目的是最大化我们地区的中风临床试验入学率。分别位于曼哈顿西侧和东侧的哥伦比亚和康奈尔（Cornell）将形成两个枢纽，并在布鲁克林和新泽西州的3家医院的额外急性治疗子网络支持下，并由3个恢复子网络组成，其中包括3个附属的学术康复中心，威斯切斯特郡和新约瑟西。我们的枢纽在中风临床试验中具有广泛的领导能力记录。仅在过去的5年中，哥伦比亚和康奈尔大学就参与了44项人类中风研究，其中包括29次中风临床试验，10项中风生物标志物研究和5项中风结果研究。在目前在枢纽和子网站的中风研究中，已招募了1,200多名患者。每个子网站都有临床试验经验，并具有中风临床试验入学率的记录，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的推荐网络。整体中，我们网络中的人口统计非常有利于入学率不足的少数群体：哥伦比亚40％西班牙裔和25％的非裔美国人；康奈尔（Cornell）15％的亚洲人和圣约瑟夫（St. Joseph）的24％非裔美国人，30％西班牙裔，其他12％。在每个主要地区，急性治疗，预防和恢复 - 以及小儿中风项目提出了三项创新的2期临床试验 - 急性治疗，预防和恢复。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诊断者，并具有广泛的高级中风相关专业知识。为了最大程度地提高每个站点的入学率，我们将在最初的6个月内每月举行一次会议，以培训现场协调员的监视和注册方法，包括如何协商EMR系统，如何与中风缺陷，使用替代招生的语言与患者接近患者，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，其中包括枢纽，子网站和推荐医院。我们的基本科学家将支持临床 通过帮助为新建议产生想法，并为在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每年将指导初级教师并培训一名血管神经病学研究员。我们建议继续Marshall博士通过我们的Spotrias Grant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。