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

基本信息

批准号：
9122514
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
项目类别：
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/9122514
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 Network Infrastructure 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 Vocational Guidance base care delivery career data management design experience human subject imaging biomarker implementation research implementation trial improved improved outcome inclusion criteria investigator training multidisciplinary operation programs repository stroke rehabilitation stroke treatment tertiary care treatment trial trial design

项目摘要

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 NIH 试验高水平入组的长期可持续模式。这与 NIH 的使命相关，即在更多中风管理领域向更多患者提供试验机会。计划：UCSD 参与了 NIH-SPOTRIAS、NIH、中风各个领域的行业和自费试验，现已获得院长、主席、IRB、合同办公室、CTRI、ED、EMS、发言人和联合机构的支持。是为了这个建议。 UCSD 已提供超过 1,000 份试验登记、超过 3,000 份数据记录存入存储库以及超过 500 个样本纳入标本研究。加州大学圣地亚哥分校 (UCSD) 目前已扩大其现有网络，总共包括 19 个设施，能够接触到儿科、康复和 EMS 患者，并争取每个辐射中心的支持，以简化临床试验协议并推迟 IRB 监督。研究：过去 25 年，加州大学圣地亚哥分校参与了众多试验的开发。 NIH 已经制定了一项 5 年计划，以实施新的试验，将试验扩展到更多中心，并为网络开发高水平的科学试验。加州大学圣地亚哥分校现在还具备了进行儿科中风和康复试验的能力。领导力：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卒中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：中风中心始终致力于为研究员提供职业指导。自 1987 年起就设立了一项研究金，并由 SPOTRIAS 加强了资助，现在这项补助金已延长。管理：标准操作程序（SOP）指导中心的各个方面，从管理笔画代码到试运行。加州大学圣地亚哥分校采用试验层次结构，其中包括参与患者获益可能性高的研究、强有力的合作伙伴关系以及关注 NIH 试验。加州大学圣地亚哥分校 (UCSD) 的 19 个 RCC 中心均制定了分配计划，以避免偏见或纳入标准重叠，并重点关注处于危险中或历史上受到限制的人群。 UCSD 是该网络 RCC 的理想选择。