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: 8662864
• 负责人: BRETT C MEYER
• 金额: $ 31.5万
• 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 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8662864
• 关键词: Acute; Agreement; Area; Biological Markers; Biological Preservation; Caliber; Caring; Childhood; Childhood stroke; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Code; Contract Services; Contracts; Data; Development; Devices; Discipline; Emergency treatment; Enrollment; Ensure; Equilibrium; Fellowship; Funding; Future; Grant; Health; Hospitals; Image; 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; implementation research; implementation trial; improved; inclusion criteria; investigator training; multidisciplinary; operation; programs; public health relevance; repository; stroke rehabilitation; tertiary care; treatment trial

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发展和快速实施，以实现高素质注册进入NIH试验的长期可持续模式。这与NIH的使命有关，即在更多的中风治疗领域将试验机会扩大到更多的患者。计划：UCSD已经参与了NIH-SPOTRIAS、NIH、行业和自筹资金的不同领域的中风试验，现在已经获得院长、主席、IRB、合同办公室、CTRI、ED、EMS、辐条和联合IS的支持。加州大学圣迭戈分校已经为试验提供了1,000多个登记，将3,000多个数据记录存入储存库，并将500多个样本纳入样本研究。UCSD现已将其目前的网络扩展到总共19个设施，使其能够接触到儿科、康复和EMS患者，并获得了每个分支中心的支持，以简化临床试验协议并推迟IRB的监督。研究：加州大学圣迭戈分校在过去的25年里参与了许多试验的开发。一项五年计划已经到位，以实施新的NIH试验，将试验扩展到更多的中心，并为该网络开发高水平的科学试验。加州大学圣迭戈分校现在还开发了在儿童中风和康复方面进行试验的能力。领导：UCSD指定了一名PI和替代PI，每个人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中风治疗的不同领域合作进行试验。试验是根据专业领域进行分配的。培训计划：中风中心致力于为研究员提供职业指导。自1987年以来一直有一项研究金，由SPOTRIAS加强，现在已经延长了这笔赠款。管理：标准操作程序(SOP)指导中心的方方面面，从管理中风代码到试运行。加州大学圣迭戈分校采用了一种试验层次结构，其中包括参与对患者有益的可能性很高的研究，牢固的合作伙伴关系，并专注于NIH试验。UCSD在19个RCC中心中的每个中心都制定了分配计划，以避免偏见或纳入标准重叠，并将重点放在高危人群或历史上重点有限的人群。 UCSD是该网络作为RCC的理想选择。