UCSD Regional Coordinating Center for the NINDS Stroke Trials Network

描述（由申请人提供）：本申请的长期目标和目的侧重于研究的发展和快速实施，以实现长期可持续的高水平注册进入NIH试验的模式。这与NIH的使命有关，即在更多的中风管理领域为更多的患者提供试验机会。项目：加州大学圣地亚哥分校参与了NIH- spotrias， NIH，行业和自费的中风各个领域的试验，现在已经得到了院长，主席，IRB，合同办公室，CTRI， ED， EMS，辐条和共同发起人的支持。加州大学圣地亚哥分校为试验提供了1000多份登记，为存储库提供了3000多份数据记录，为标本研究提供了500多份样本。加州大学圣地亚哥分校现在已经扩大了其现有的网络，包括总共19个设施，可以访问儿科，康复中心和EMS患者，并获得了每个spoke中心的支持，以简化临床试验协议并推迟IRB的监督。研究：在过去的25年里，加州大学圣地亚哥分校参与了许多试验的开发。一项5年计划正在实施新的NIH试验，将试验扩展到更多的中心，并为该网络开发高水平的科学试验。加州大学圣地亚哥分校现在也发展了在儿童中风和康复方面进行试验的能力。领导：加州大学圣地亚哥分校指定了一个PI和替代PI，每个PI都有资格有效地担任这一角色。在多学科临床试验团队中，来自不同学科的专家可以在卒中管理的不同领域进行合作。试验是根据专业领域分配的。训练计划：脑卒中中心完全致力于为奖学金生提供职业指导。自1987年以来一直有一项研究金，由SPOTRIAS加强，现在延长了这项赠款。管理：标准操作程序（sop）指导中心的各个方面，从管理中风代码到试验操作。加州大学圣地亚哥分校采用试验等级制度，其中包括参与具有高患者获益可能性的研究，强有力的合作伙伴关系以及对NIH试验的关注。加州大学圣地亚哥分校在19个RCC中心都有一个分配计划，以避免偏见或纳入标准重叠，并专注于有风险的人群或历史上有限的人群。

DESCRIPTION (provided by applicant): The long-term objectives and aims of this application focus on the development and rapid implementation of research, to enable a long-term sustainable model of high caliber enrollments into NIH trials. This is relevant to the NIH's mission of extending trial opportunities to more patients in more areas of stroke management. Program: UCSD has participated in NIH-SPOTRIAS, NIH, industry and self-funded trials in various areas of stroke and has now engaged the support of the Dean, Chair, IRB, Contracting Office, CTRI, ED, EMS, spokes and Co-Is for this proposal. UCSD has provided over 1,000 enrollments into trials, over 3,000 data records into repositories and over 500 samples into specimen studies. UCSD has now expanded its current network to include a total of 19 facilities enabling access to pediatric, rehab, and EMS patients and has enlisted the support of each spoke center to streamline clinical trial agreements and defer IRB oversight. Research: UCSD has participated in development of numerous trials in the past 25 years. A 5 year plan is in place to implement new NIH trials, expand trials into more centers, and develop high caliber scientific trials for the network. UCSD has now also developed a capacity for performing trials in pediatric stroke and rehab. Leadership: UCSD has designated a PI and substitute PI, each with qualifications to serve effectively in this role. In the multidisciplinary clinical trials' team, eperts from various disciplines are available to collaborate on trials in diverse arenas of stroke management. Trials are assigned based on area of expertise. Training Program: The Stroke Center maintains full commitment to career guidance for fellows. A fellowship has been in place since 1987, was enhanced in by SPOTRIAS, and now has been extended for this grant. Administration: Standard operating procedures (SOPs) guide all aspects of the center ranging from managing stroke codes to trial operations. UCSD uses a trial hierarchy which includes participating in research with high likelihood of patient benefit, strong partnerships and a focus on NIH trials. UCSD has an allocation plan in place at each of the 19 RCC centers to avoid bias or inclusion criteria overlap, and focus on populations at risk or with historically limited focus. UCSD is an ideal choice as an RCC for this network.