NIH StrokeNet National Clinical Coordinating Center

中风是世界上第二大死亡原因，严重残疾的负担甚至更大。它 各年龄段均可发生，以老年人发病率最高。美国中风人数预计将上升 随着人口的老龄化，世界也会变得更加脆弱。据估计，2013年该公司在美国的直接和间接成本为1,096亿美元。 2013年，美国国家神经疾病和中风研究所(NINDS)建立了一个中风网络 临床试验中心优先并有效地设计和进行探索性(第二阶段)和验证性试验 (第三阶段)中风临床试验，以及为培训下一代临床 中风研究人员。NIH StrokeNet是一个多学科中风研究基础设施，包括 国家临床协调中心、国家数据管理中心(NDMC)、25个区域协调中心 中心及其相关的地区医院，以及NINDS。它的任务是开发和测试新的疗法 用于中风的治疗、康复和预防，可以减轻全球中风的负担。 全国协调委员会的作用是与该网络所涉各方建立和促进合作关系， 在中风试验的开发和执行方面提供科学和业务领导，并 监督StrokeNet成员在StrokeNet内的教育发展。从科学的角度来看，我们 建立了三个中风工作组(急性、预防和康复/康复)，工作组由 来自NCC的具有适当专业知识的高级临床研究人员领导。这些工作小组帮助私人投资经理 具有科学设计和给定试验可行性的临床试验建议。一个成像核心，和四个咨询 以NCC为中心的委员会(少数族裔招募和保留、血管内、儿科和伦理)， 还为临床试验的开发和执行提供投入。在业务上，NCC设有中央IRB (CIRB)正在进行的StrokeNet试验，涉及辛辛那提大学和CIRB之间的信任协议 300多家当地机构，美国最大的IRB信赖网之一。NCC负责MASTER 所有农村信用社和381个参与医院站点的试验协议，向参与站点支付的所有财务款项 关于试验任务，以及正在进行的试验的整体临床研究管理，与各自的PI合作。 最后，NCC拥有StrokeNet的教育和指导核心，提供教育和培训 关于中风和中风研究，在NIH StrokeNet(至少有一个 每个RCC每年的研究员)。

Stroke is the second leading cause of death in the world with an even greater burden of major disability. It occurs at all ages with the greatest incidence in the elderly. The number of stroke is expected to rise in the US and the world as the population ages. Its estimated direct and indirect cost in the U.S. for 2013 is $109.6 billion. In 2013, the National Institute of Neurological Disorders and Stroke (NINDS) formed a network of stroke clinical trials centers to prioritize and efficiently design and conduct exploratory (Phase II) and confirmatory (Phase III) clinical stroke trials as well as to provide a mechanism for training of the next generation of clinical stroke researchers. The NIH StrokeNet is a multidisciplinary stroke research infrastructure that includes a National Clinical Coordinating Center, a National Data Management Center (NDMC), 25 Regional Coordinating Centers and their associated regional hospitals, and the NINDS. Its mission is to develop and test new therapies for stroke treatment, recovery, and prevention that can decrease the global burden of stroke. The NCC's roles are to establish and foster a collaborative relationship with all parties involved in the Network, to provide scientific and operational leadership in the development and execution of the stroke trials, and to oversee the educational development of StrokeNet fellows within StrokeNet. From a scientific standpoint, we have established three stroke working groups (acute, prevention and recovery/rehabilitation) that are led by senior clinical investigator leaders from the NCC with appropriate expertise. These working groups help PIs of clinical trial proposals with the scientific design and feasibility of a given trial. An imaging core, and four advisory committees (minority recruitment and retention, endovascular, pediatrics and ethics), centered within the NCC, also provide input to clinical trial development and execution. Operationally, the NCC houses the Central IRB (CIRB) for ongoing StrokeNet Trials that involves reliance agreements between the University of Cincinnati and over 300 local institutions, one of the largest IRB reliance networks in the U.S. The NCC is responsible for master trial agreements for all RCCs and the 381 participating hospital sites, all financial payments to participating sites regarding trial tasks, and the overall clinical study management of ongoing trials working with the respective PIs. Finally, the NCC houses the educational and mentoring core for the StrokeNet that provide education and training regarding stroke and stroke research to a broad base of diverse individuals within NIH StrokeNet (at least one fellow per RCC per year).