StrokeBelt StrokeNet

中风带中风网

• 批准号: 10246503
• 负责人: Toby Gropen
• 金额: $ 29.85万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10246503
• 关键词: Agreement; Alabama; Area; Awareness; Basic Science; Child; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Communities; Data Analyses; Development; Enrollment; Heart; Hospital Referrals; Image; Improve Access; Industry; Infrastructure; Institution; Institutional Review Boards; Knowledge; Medical center; Methods; Minority; Minority Groups; Mississippi; Modeling; Monitor; Neurologist; Neurology; Neurosurgeon; Patients; Performance; Phase; Population; Populations at Risk; Prevention; Protocols documentation; Public Health Schools; Quality Control; Recovery; Rehabilitation therapy; Research; Research Personnel; Resources; Robotics; Science; Scientist; Stroke; Stroke Belt; StrokeNet clinical trials; StrokeNet trials; Training; Translational Research; Underrepresented Populations; United States; United States National Institutes of Health; Universities; Work; acute stroke; aphasia recovery; care systems; cerebrovascular; clinical center; collaborative environment; data management; experience; health disparity; human subject; minority communities; minority health; motor recovery; neurosurgery; next generation; operation; patient oriented; programs; recruit; screening; stroke clinical trials; stroke patient; stroke recovery; stroke therapy; telerehabilitation

The proposed StrokeBelt StrokeNet (SBSN) RCC will benefit from the established infrastructure, basic science and clinical stroke expertise, and stroke clinical trial experience at UAB, and work with established partner institutions in the Southeastern US, including Children’s of Alabama, the UAB/Lakeshore Research Collaborative, the University of Mississippi Medical Center, and the University of South Alabama. Each institution has its own network of referral hospitals, clinical trial infrastructure and experience enrolling in stroke clinical trials. The result is that a large part of the Stroke Belt will have access to StrokeNet Clinical Trials. The SBSN will succeed by leveraging key attributes of our region and network. First, the SBSN RCC will offer combined access to nearly 3,500 acute stroke patients annually, many of them minorities, in an underserved part of the US. As in our NeuroNext program, we will aggressively pursue the inclusion of underrepresented and minority populations in our clinical trials through collaboration with the Minority Health and Health Disparities Research Center (MHRC) and Strengthening Translational Research in Diverse Enrollment (STRIDE). Second, UAB and its partners have a track record of patient‐ oriented stroke research and successful stroke clinical trial recruitment. Over the last 3 years, UAB alone has participated in 20 NIH‐ or industry‐sponsored multicenter phase 1, 2 and 3 trials in stroke treatment, prevention, and recovery, enrolling 401 patients. We were nationally‐leading recruiters in the TUCSON, CUFFS, CLOTBUST‐HF, SAMMPRIS and CLEAR III trials. We actively enrolled in the first StrokeNet trial, DEFUSE3, are currently enrolling in CREST‐2, and preparing for participation in ARCADIA and CREST‐H. We are the leading recruiting center in MyRIAD and the second leading center for MISTIE III. Over the last 3 years, SBSN institutions/investigators have participated in a total of 37 trials in stroke treatment, prevention, and recovery, and enrolled a total of 2050 subjects. Third, we have extensive experience in stroke recovery with specific expertise in stroke‐related aphasia recovery/rehabilitation, TMS and imaging, motor recovery, tele‐rehabilitation and robotics. Fourth, our proposed network will be strengthened by the already‐strong connections between the UAB Center for Clinical and Translational Science (CCTS) and our partner institutions. All of the institutions in our proposed network are already our partners, and already have experience with master IRB reliance agreements. Fifth, our research program will build upon our already‐successful recruitment by applying a performance improvement approach to enhance clinical trial screening, enrollment and retention. Strategies include specific screening, enrollment and retention methods; rigorous and continuous monitoring and performance improvement of trial implementation and subject screening, enrollment and retention; training and sharing of best practices; and programs to enhance engagement and enthusiasm of investigators and coordinators across the network. Sixth, the training of stroke clinical scientists at UAB will be enhanced through programs developed with the UAB CCTS and UAB School of Public Health (SOPH).

拟议的StrokeBelt StrokeNet（SBSN）RCC将受益于现有的基础设施、基础科学和 临床中风专业知识，在UAB的中风临床试验经验，并与既定的合作伙伴机构合作 在美国东南部，包括亚拉巴马的儿童，UAB/湖岸研究合作，大学 密西西比医学中心和南亚拉巴马大学。每个机构都有自己的转介网络 医院、临床试验基础设施和卒中临床试验入组经验。结果是， 中风带的人将可以访问中风网临床试验。SBSN将通过利用 我们的区域和网络首先，SBSN RCC将为近3，500名急性卒中患者提供综合治疗 他们中的许多人是少数民族，在美国服务不足的地区。在我们的NeuroNext计划中，我们将 积极寻求在我们的临床试验中纳入代表性不足和少数群体， 与少数民族健康和健康差异研究中心（MHRC）合作，加强 多样化招生中的转化研究（STRIDE）。其次，UAB及其合作伙伴有一个病人的跟踪记录， 面向中风研究和成功的中风临床试验招募。在过去的三年里，仅UAB就有 参加了20项NIH或行业赞助的中风治疗、预防、 和恢复期，入组401例患者。我们是TUCSON，CUFFS，CLOTBUST-HF， SAMMPRIS和CLEAR III试验。我们积极参加了第一个StrokeNet试验DEFUSE 3，目前正在参加 CREST-2，并准备参加阿卡迪亚和CREST-H。我们是MyRIAD领先的招聘中心 也是MISTIE III的第二大中心。在过去3年中，SBSN机构/研究者参与了 在总共37项关于中风治疗、预防和康复的试验中，共招募了2050名受试者。三是 具有丰富的中风恢复经验，并具有中风相关失语症的专业知识 康复/康复，TMS和成像，运动康复，远程康复和机器人技术。第四，我们的建议 网络将通过UAB临床中心和 翻译科学（CCTS）和我们的合作伙伴机构。我们提议的网络中的所有机构都已经 我们的合作伙伴，并已与主IRB依赖协议的经验。第五，我们的研究计划将 在我们已经成功的招聘基础上，应用绩效改进方法来提高 临床试验筛选、入组和保留。策略包括特定的筛选、入组和保留 方法;严格和持续的监测和性能改进试验实施和受试者 筛选、登记和保留;培训和分享最佳做法;以及提高参与度的方案 以及整个网络的调查人员和协调员的热情。第六，脑卒中临床科学家的培养 在UAB将通过与公共卫生（SOPH）的UAB CCTS和UAB学校开发的计划得到加强。