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NIH StrokeNet National Clinical Coordinating Center

NIH StrokeNet National Clinical Coordinating Center
NIH StrokeNet 国家临床协调中心
批准号:
10251057
负责人:
Joseph Paul Broderick
金额:
$239.14万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2013
资助国家:
美国
项目状态:
已结题
起止时间:
2013-09-30 至 2023-07-31

项目摘要

项目成果

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中文摘要
翻译
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 发生在所有年龄段,老年人的发病率最高。预计美国的中风人数将上升 以及世界人口老龄化的趋势。2013年,其在美国的直接和间接成本估计为1096亿美元。 2013年,美国国家神经疾病和中风研究所(NINDS)组建了一个中风网络, 临床试验中心优先考虑和有效地设计和进行探索性(II期)和验证性 (III期)临床中风试验以及为下一代临床 中风研究者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。它的使命是开发和测试新的疗法 用于中风治疗、康复和预防,可以减少中风的全球负担。 NCC的作用是建立和促进与网络所涉各方的合作关系, 在中风试验的开发和执行中提供科学和操作领导, 监督StrokeNet内StrokeNet研究员的教育发展。从科学的角度来看,我们 成立了三个中风工作组(急性、预防和恢复/康复),由 来自NCC的具有适当专业知识的高级临床研究者领导。这些工作小组协助 临床试验建议书,设计科学,试验可行。一个成像核心,四个顾问 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), 还为临床试验开发和执行提供输入。在运作上,NCC设有中央IRB (CIRB)正在进行的StrokeNet试验,涉及辛辛那提大学和 超过300个当地机构,是美国最大的IRB依赖网络之一。 所有RCC和381家参与医院研究中心的试验协议,所有对参与研究中心的财务支付 关于试验任务,以及与各自PI合作的正在进行的试验的总体临床研究管理。 最后,NCC为StrokeNet提供教育和培训的教育和指导核心 关于中风和中风研究,以广泛的基础上不同的个人在NIH中风网络(至少有一个 每年每个RCC的研究员)。
英文摘要
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).
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FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
  • 批准号:
    9714832
  • 项目类别:
  • 资助金额:
    $647.23万
  • 财政年份:
    2020
  • 负责人:
    Joseph Paul Broderick
  • 依托单位:
FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
  • 批准号:
    10116504
  • 项目类别:
  • 资助金额:
    $513.04万
  • 财政年份:
    2020
  • 负责人:
    Joseph Paul Broderick
  • 依托单位:
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenicstroke (ARCADIA)
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenicstroke (ARCADIA)
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