Neurological Emergencies Treatment Trial Network Statistical/Data Management Ctr

描述（由申请人提供）：神经急症治疗试验（NETT）网络的总体目标是通过在早期护理阶段确定有效的治疗方法来改善急性神经疾病和损伤患者的预后。在制定NETT的过程中，NINDS认识到临床前和转化研究表明，神经急症的新治疗方法达到最佳效果的机会窗口非常狭窄，并且在急症环境中进行研究对临床研究人员提出了独特的实际挑战。在过去的四年中，NETT已被证明是一个能够选择、开发和同时开展多项在救护车或急诊科（ED）提供的非常早期干预措施的验证性临床试验的平台。NETT已经成功争取到资金，并实施了四项积极招募的临床试验，其中两项使用了知情同意例外（EFIC），其中一项已经接近完成。其他几项试验正在与NETT内部和外部的研究人员一起开发。在NETT开展的所有试验中，受试者应计收益已超出预期并在预算范围内。成功的运作可归因于NETT组织和流程的效率。NETT的协调活动得到了两项NINDS合作协议的支持，分别是密歇根大学临床协调中心（U01 NS056975）和南卡罗莱纳医科大学生物统计与流行病学学部统计与数据管理中心（SDMC） （U01 NS059041）。此外，17个学术中心（hub）参与了NETT，每个中心都得到了NINDS的R01拨款支持。在第二个五年拨款期内，SDMC的目标是维持与全国临床研究中心有关各方的合作关系，并继续为全国临床研究中心进行的临床试验提供有效的数据管理支持和统计专业知识。我们还将探索临床试验设计的创新，包括适应性研究设计。

DESCRIPTION (provided by applicant): The overall goal of the Neurological Emergencies Treatment Trials (NETT) Network is to improve the outcomes of patients with acute neurological illness and injury by identifying effective treatments given in the earliest stages of care. In developing the NETT, the NINDS recognized that pre-clinical and translational research has demonstrated that there is a very narrow window of opportunity in which novel treatments for neurological emergencies are optimally effective, and that conducting research in the emergency setting presents unique pragmatic challenges to clinical investigators. Over the past four years, the NETT has proven to be a platform capable of selecting, developing, and simultaneously conducting multiple confirmatory clinical trials of very early interventions delivered in the ambulance or the emergency department (ED). The NETT has successfully competed for funding and implemented four actively enrolling clinical trials, two of which utilize exception from informed consent (EFIC), and one of which is already nearing completion. Several other trials are being developed with investigators from within as well as outside of the NETT. In all the trials initiated in NETT, subject accrual has been ahead of expectations and on budget. The successful operation can be attributed to the efficiency of the NETT organization and processes. The coordinating activities of the NETT is supported by two NINDS cooperative agreement grants to the Clinical Coordinating Center (CCC) at the University of Michigan (U01 NS056975) and the Statistical and Data Management Center (SDMC) in the Division of Biostatistics and Epidemiology (DBE) at the Medical University of South Carolina (U01 NS059041). In addition, 17 academic centers (Hubs) participate in the NETT with R01 grant support to each center from the NINDS. For the second five-year grant period, the SDMC's aims are to maintain the collaborative relationship with all parties involved in the NETT and to continue to provide efficient data management support and statistical expertise for clinical trials to be conducted by the NETT. We will also explore innovations in clinical trial designs including adaptive Study designs.