State University of New York (SUNY) Downstate NETT Clinical Site Hub

纽约州立大学 (SUNY) 州下 NTT 临床站点中心

• 批准号: 8401735
• 负责人: STEVEN Richard LEVINE
• 金额: $ 33.94万
• 依托单位: SUNY DOWNSTATE MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8401735
• 关键词: Acute; Adult; Area; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Communities; Community Hospitals; Community Networks; Complex; Conduct Clinical Trials; Critical Care; Data; Disease; Emergency Medicine; Emergency treatment; Epilepsy; Ethics; Faculty; Fire - disasters; Funding; Goals; Health Sciences; Hispanics; Hospitals; Information Technology; Informed Consent; Joints; Leadership; Medical center; Medicine; Mentors; Minority; Morbidity - disease rate; National Institute of Neurological Disorders and Stroke; Neurological emergencies; Neurology; New York; New York City; Participant; Patients; Pediatric Neurology; Pediatrics; Performance; Pharmacy facility; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Physicians; Population; Public Health; Public Hospitals; Radiology Specialty; Randomized; Randomized Clinical Trials; Recording of previous events; Recruitment Activity; Rehabilitation therapy; Research; Research Infrastructure; Research Personnel; Research Training; Risk; Seizures; Site; Stroke; Structure; System; Teaching Hospitals; Telemedicine; Training; Training Programs; Trauma; Underrepresented Minority; United States National Institutes of Health; Universities; Visit; Work; base; clinical practice; clinical research site; effective therapy; experience; improved; innovation; mortality; nervous system disorder; neurosurgery; programs; racial and ethnic; success; treatment trial

DESCRIPTION (provided by applicant): The State University of New York (SUNY) Downstate Medical Center has created a Clinical Site Hub and Spoke NETT to join a national clinical research network. Our 5-hospital NETT, included within federally designated underserved areas, serves a large minority population, will conduct clinical trials designed to develop effective treatments for patients with neurological emergencies. Our existing infrastructure of the Hub at SUNY Downstate Medical Center, with joint experienced leadership from Emergency Medicine and Neurology, has established 2 large spokes: Lincoln Hospital (south Bronx), serving primarily Hispanics, and Maimonides Medical Center (Brooklyn), one of the largest independent teaching hospitals in the US. We work collaboratively with investigators and clinicians in critical care, neurosurgery, Trauma, Stroke, and Epilepsy Centers, Neuroradiology, Rehabilitation, Community Engagement/ Disparities Research, Fire Department of New York (FDNY) Pre-Hospital 911 System, Pharmacy, and Information Technology. Our goal is to identify, recruit, and retain a large number of participants from highly diverse backgrounds in high quality clinical research in neurological emergencies using best research practices and the highest ethical standards of research conduct. We will facilitate the transfer of research results to clinical practice via active dissemination of study findings. We are mentoring junior faculty, including minority investigators, in the conduct of phase 3 randomized clinical trials. Our growing infrastructure includes a recently NINDS-funded SUNY NeuroNEXT UIO for phase 2 trials among other formalized and funded research and training programs. This NETT is jointly led by experienced clinical trialists well-versed in complex multi-center administrative structure and projects with established mentoring programs and a growing cadre of acute neurology subspecialists. Our NETT includes a combined annual ED volume of over 350,000 visits, with over 3,500 neurological emergencies. Strengths include the extremely diverse, large patient pool, extensive NIH clinical trials experience, detailed ED visit data from all hospitals, acute telemedicine experience, expertise in exemption from informed consent, and well-established, extensive community networks and engagement. PUBLIC HEALTH RELEVANCE: Neurological Emergencies are a major cause of morbidity and mortality in the US and are extremely costly illnesses. There is a great need to develop proven treatments for these conditions. There is also a disproportionate risk and burden on underrepresented minorities (URM) for many types of neurological emergencies which our NETT Clinical Hub Site and Spokes has been focusing on for recruitment. We also will train UBM investigator's in the conduct of clinical trials.

描述(由申请人提供)：纽约州立大学(SUNY)DownState医学中心已经创建了一个临床站点中心并发言NETT加入了一个全国性的临床研究网络。我们的5家医院NETT包括在联邦指定的服务不足地区，服务于大量少数族裔人口，将进行临床试验，旨在为患有神经紧急情况的患者开发有效的治疗方法。我们现有的基础设施 纽约州立大学下州医疗中心的HUB在急诊医学和神经病学的联合经验丰富的领导下，建立了两个大型分支机构：主要为拉美裔服务的林肯医院(南布朗克斯)和美国最大的独立教学医院之一迈蒙尼德医疗中心(布鲁克林)。我们与重症监护、神经外科、创伤、中风和癫痫中心、神经放射学、康复、社区参与/差异研究、纽约消防局(FDNY)医院前911系统、药房和信息技术等领域的研究人员和临床医生合作。我们的目标是利用最好的研究实践和最高的研究行为道德标准，在神经急诊的高质量临床研究中识别、招募和留住来自高度不同背景的大量参与者。我们将通过积极传播研究成果，促进研究成果转化为临床实践。我们正在指导初级教员，包括少数族裔研究人员，进行第三阶段随机临床试验。我们不断增长的 基础设施包括最近由NINDS资助的纽约州立大学NeuroNEXT UIO，用于第二阶段试验，以及其他正式和资助的研究和培训计划。这一NETT由经验丰富的临床试验专家共同领导，他们精通复杂的多中心管理结构和项目，拥有既定的指导计划和不断增长的急性神经病学专家队伍。我们的NETT包括每年超过350,000人次的急诊量，以及超过3,500例神经急诊。优势包括极其多样化、庞大的患者群体、广泛的NIH临床试验经验、来自所有医院的详细急诊数据、急性远程医疗经验、豁免知情同意的专业知识以及完善的广泛的社区网络和参与。 与公共卫生相关：神经紧急情况是美国发病率和死亡率的主要原因，是代价极其高昂的疾病。非常需要为这些疾病开发经过验证的治疗方法。对于我们的NETT临床中心网站和Spokes招募的许多类型的神经紧急情况，代表不足的少数族裔(URM)也面临着不成比例的风险和负担。我们还将对UBM研究员进行临床试验方面的培训。