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State University of New York (SUNY) NEXT Clinical Site

纽约州立大学 (SUNY) NEXT 临床中心

基本信息

批准号：
10593616
负责人：
STEVEN Richard LEVINE
金额：
$ 31.59万
依托单位：
SUNY DOWNSTATE MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10593616
关键词：
Adult Catchment Area Child Childhood Clinic Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Comb animal structure Communities Community Outreach Conduct Clinical Trials County Data Coordinating Center Development Disease Ethics Eye Faculty Funding Geography Goals Grant Growth Health Health care facility Hospitals Industry Infrastructure Inpatients Institutes Institutional Review Boards Leadership Local Government Medical Mentors Modeling Morbidity - disease rate National Institute of Neurological Disorders and Stroke Neurologic Neurology Neurosciences New York Participant Patient Recruitments Patients Pediatric Hospitals Performance Population Population Heterogeneity Positioning Attribute Privatization Protocols documentation Public Health Publications Research Research Infrastructure Research Personnel Resources Review Committee Rural Site Specialist Speed State Government Structure Telemedicine Testing Time TimeLine Training Translational Research Translations Underrepresented Minority Underserved Population United States Universities Wages Work base career clinical investigation clinical research site community organizations community partnership cost effective data quality data sharing effective therapy electronic data ethnic diversity experience geographic population improved innovation meetings member minority investigator mortality nervous system disorder organizational structure outpatient facility patient advocacy group patient population phase III trial racial and ethnic recruit response retention rate rural Americans rural healthcare rural patients success

项目摘要

This application from the State University of New York (SUNY) responds to the NINDS RFA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). We have brought together the 4 SUNY Academic Health Centers (AHCs), their local, diverse communities, and their liaisons with hospital (including 4 children's hospitals) and clinic networks, large referral bases and patient volumes, and industry. This will insure a robust and accessible infrastructure to facilitate rapid developmental and implementation of protocols for adults and children to be recruited into neurological clinical trials throughout NY state. By combing 4 SUNY campuses into one application, we have created a highly innovative and considerable network of patients with extremely diverse ethnic and racial backgrounds combined with vast breadth and depth of faculty (over 100) disease subspecialization and expertise. Approximately 42% of the state's population lives within the counties/boroughs serves by this SUNY NEXT application. The SUNY NEXT is therefore in a position to shift performance models and improve public health on a faster timeline because of the size of the referral and catchment area and generalizability of the diverse patients seen. Momentum for highly successful SUNY cross-campus projects has increased dramatically in the past 8 years with key leadership forming and supporting the formation of SUNY Research Excellence in Academic Health (REACH) via institutional hard dollars and grants. This SUNY NEXT proposal will further enhance infrastructure and expand our multi-campus Clinical Trials Network that currently includes a U10 SUNY NEXT, U10 NETT Hub, U10 StrokeNET sites, U24 SIREN SubHub, and now a CTSA. Our experience includes over neurology 100 trials in the past 8+ years. We have built this network and continue to refine it to provide a comprehensive array of disease-specific expertise (adults and pediatric neurologic specialists/subspecialists), clinical trial expertise and experience including trial coordinators, clinical/ translational research infrastructure, institutional commitment, and ongoing/expanding community-based input and research. Our network can coordinate a large, geographically diverse cadre of disease-based investigators to implement studies efficiently in response to disease-specific opportunities (MTAs and cIRB use already in place), supported by SUNY NEXT currently in the top 1/3 (8th of 25) of NEXT sites for recruitment and retention with outstanding data quality. We also have a group of early stage investigators (ESIs), including under-represented minority investigators, who we will train and mentor in trials (including SUNY-wide video subspecialty telementoring) and who will compete for a yearly slot that protects time with funded salary support. We will explore, given our expertise and connectivity in telemedicine, the feasibility of performing trials to more remote, smaller sites affiliated with SUNY NEXT to gain even greater representation of rural Americans into trials. Our success will shift paradigms for collaborative structuring of trials and ultimately improve public health.

纽约州立大学(SUNY)的这份申请是为了响应NINDS RFA作为神经科学临床试验卓越网络(NEXT)的一个临床站点。我们汇集了4个纽约州立大学学术健康中心(AHC)，他们的当地不同社区，以及他们与医院(包括4家儿童医院)和诊所网络、大型转诊基地和患者数量以及行业的联系。这将确保一个强大和可访问的基础设施，以促进快速开发和实施成人和儿童方案，以便在整个纽约州纳入神经学临床试验。通过将4个纽约州立大学校区合并为一个应用程序，我们创建了一个高度创新的相当大的患者网络，这些患者具有极其不同的民族和种族背景，并拥有广泛的教师广度和深度(超过100人)的疾病亚专科和专业知识。该州约42%的人口生活在这项纽约州立大学下一项申请所服务的县/区内。因此，纽约州立大学NeXT能够以更快的时间表转变绩效模式和改善公共卫生，因为转诊和收集区域的大小以及所看到的不同患者的普遍性。在过去的8年里，纽约州立大学非常成功的跨校园项目的势头急剧增强，主要领导层通过机构硬通货和赠款形成并支持了纽约州立大学学术健康卓越研究(REACH)的形成。这项纽约州立大学NEXT计划将进一步加强基础设施，并扩大我们的多园区临床试验网络，该网络目前包括U10 SUNY NEXT、U10 NETT中枢、U10 StrokeNET站点、U24警报子枢纽，现在还包括CTSA。我们的经验包括在过去8年多的时间里进行了100多项神经学试验。我们已经建立了这个网络，并继续完善它，以提供全面的疾病特定专业知识(成人和儿童神经学专家/小组专家)、临床试验专业知识和经验，包括试验协调员、临床/转化性研究基础设施、机构承诺以及持续/不断扩大的基于社区的投入和研究。我们的网络可以协调大量不同地域的疾病研究人员队伍，以有效地实施研究，以应对特定疾病的机会(MTA和CIRB的使用已经到位)，并得到纽约州立大学NeXT的支持，目前在NEXT招聘和保留网站中排名前三分之一(25个网站中的第8个)，数据质量出色。我们还有一组早期调查人员(ESIS)，包括代表性不足的少数族裔调查人员，他们将在审判中进行培训和指导(包括全纽约大学的视频专业远程监控)，他们将竞争年度职位，通过提供资金的工资支持来保护时间。鉴于我们在远程医疗方面的专业知识和连通性，我们将探索在更偏远、更小的附属于纽约州立大学的地点进行试验的可行性，以便在试验中获得更多美国农村人的代表。我们的成功将改变试验协作结构的模式，并最终改善公共卫生。

项目成果

期刊论文数量（13）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Comparison of short-term outcomes of thrombolysis for in-hospital stroke and out-of-hospital stroke in United States.

DOI：
10.1161/strokeaha.113.000945
发表时间：
2013-07
期刊：
Stroke
影响因子：
8.3
作者：
Moradiya Y;Levine SR
通讯作者：
Levine SR

Review, historical context, and clarifications of the NINDS rt-PA stroke trials exclusion criteria: Part 1: rapidly improving stroke symptoms.

DOI：
10.1161/strokeaha.113.000878
发表时间：
2013-09
期刊：
Stroke
影响因子：
8.3
作者：
Re-examining Acute Eligibility for Thrombolysis (TREAT) Task Force:;Levine SR;Khatri P;Broderick JP;Grotta JC;Kasner SE;Kim D;Meyer BC;Panagos P;Romano J;Scott P;NINDS rt-PA Stroke Trial Investigators
通讯作者：
NINDS rt-PA Stroke Trial Investigators

The A's and B's of the ABC's of stroke mechanisms and recurrence in pediatric ischemic stroke.

小儿缺血性中风的中风机制和复发 ABC 的 A 和 B。