UCSD Regional Coordinating Center for the NINDS Stroke Trials Network

加州大学圣地亚哥分校 NINDS 卒中试验网络区域协调中心

• 批准号: 8895096
• 负责人: BRETT C MEYER
• 金额: $ 21.1万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8895096
• 关键词: Acute; Agreement; Area; Biological Preservation; Caliber; Caring; Childhood; Childhood stroke; Clinical; Clinical Research; Clinical Trials; Code; Contract Services; Contracts; Data; Development; Devices; Discipline; Emergency treatment; Enrollment; Ensure; Equilibrium; Fellowship; Funding; Future; Grant; Health; Hospitals; Industry; Institutional Review Boards; International; Intervention; Leadership; Manuscripts; Mission; Modeling; Multi-Institutional Clinical Trial; National Institute of Neurological Disorders and Stroke; Nerve Regeneration; Neurological emergencies; Outcome; Patients; Performance; Phase; Population; Populations at Risk; Principal Investigator; Procedures; Productivity; Public Health; Recording of previous events; Records; Recovery; Rehabilitation therapy; Research; Research Design; Research Infrastructure; Research Personnel; Research Training; Role; Sampling; Services; Specialist; Specimen; Stroke; Stroke prevention; Techniques; Time; Training; Training Programs; United States; United States National Institutes of Health; base; care delivery; career; data management; design; experience; human subject; imaging biomarker; implementation research; implementation trial; improved; inclusion criteria; investigator training; multidisciplinary; operation; programs; repository; stroke rehabilitation; tertiary care; treatment trial; trial design

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.

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开发和快速实施，以实现高质量入组NIH试验的长期可持续模式。这与NIH的使命有关，即在更多的中风管理领域将试验机会扩展到更多的患者。程序：UCSD参与了NIH-SPOTRIAS、NIH、行业和自筹资金的中风各个领域的试验，目前已获得院长、主席、IRB、合同办公室、CTRI、艾德、EMS、spoke和Co-Is对该提案的支持。UCSD已经提供了1,000多个试验登记，3,000多个数据记录到存储库，500多个样本到标本研究。加州大学圣地亚哥分校现在已经扩大了其目前的网络，包括总共19个设施，使儿科，康复和EMS患者的访问，并争取每个辐条中心的支持，以简化临床试验协议和推迟IRB监督。研究：在过去的25年里，UCSD参与了许多试验的开发。一项为期5年的计划已经到位，以实施新的NIH试验，将试验扩展到更多的中心，并为网络开发高质量的科学试验。加州大学圣地亚哥分校现在也发展了在儿科中风和康复方面进行试验的能力。领导力：UCSD已经指定了一个PI和替代PI，每个人都有资格有效地担任这个角色。在多学科临床试验团队中，来自不同学科的专家可以在中风管理的不同领域合作进行试验。试验是根据专业领域分配的。培训计划：中风中心保持充分的承诺，为研究员的职业指导。自1987年以来一直有一项研究金，SPOTRIAS加强了这项研究金，现在又扩大了这项赠款。管理：标准操作程序（SOP）指导中心的各个方面，从管理笔划代码到试运行。UCSD使用试验层次结构，包括参与患者受益可能性高的研究，强大的合作伙伴关系和对NIH试验的关注。UCSD在19个RCC中心中的每个中心都有一个分配计划，以避免偏倚或纳入标准重叠，并专注于风险人群或历史上关注有限的人群。 UCSD是这个网络的RCC的理想选择。