Neurological Emergencies Treatment Trial Network Statistical/Data Management Ctr

神经急症治疗试验网络统计/数据管理中心

• 批准号: 8323240
• 负责人: VALERIE L DURKALSKI
• 金额: $ 221.01万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323240
• 关键词: Academic Medical Centers; Accident and Emergency department; Acute; Address; Adult; Agreement; Ambulances; American; Applications Grants; Architecture; Biometry; Brain Injuries; Budgets; Caring; Case Report Form; Childhood; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Communication; Communities; Community Hospitals; Companions; Country; Data; Databases; Development; Early treatment; Economics; Educational workshop; Elements; Emergency Situation; Emergency treatment; Enrollment; Ensure; Environment; Epidemiology; Feedback; Fostering; Funding; Future; Goals; Grant; Hospitals; Housing; Individual; Information Networks; Informed Consent; Injury; International; Intervention; Journals; Leadership; Maintenance; Manuscripts; Medical; Methods; Michigan; Multicenter Trials; National Institute of Neurological Disorders and Stroke; Nature; Neurologic; Neurological emergencies; Neurologist; Neurosurgeon; Online Systems; Outcome; Paramedical Personnel; Patient Care; Patients; Peer Review; Phase; Phase III Clinical Trials; Physicians; Population; Principal Investigator; Process; Productivity; Protocols documentation; Publishing; Recruitment Activity; Rehabilitation therapy; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Safety; Schedule; Site; Societies; South Carolina; Speed; Spinal cord injury; Staging; Statistical Methods; Stroke; Surgeon; Surveys; System; Translational Research; Translations; Trauma; Traumatic Brain Injury; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Work; abstracting; clinical practice; data management; data sharing; design; effective therapy; expectation; human subject protection; improved; innovation; meetings; method development; novel; operation; patient oriented; patient population; pragmatic trial; pre-clinical research; primary outcome; programs; sound; statistical center; success; treatment trial

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.

描述（由申请人提供）：神经系统紧急情况治疗试验（NETT）网络的总体目标是通过确定在护理的最早阶段给予的有效治疗来改善急性神经系统疾病和损伤患者的结局。在开发NETT的过程中，NINDS认识到，临床前和转化研究已经证明，对于神经系统紧急情况的新治疗方法具有最佳效果的机会窗口非常狭窄，并且在紧急情况下进行研究对临床研究人员提出了独特的务实挑战。在过去的四年中，NETT已被证明是一个平台，能够选择，开发，并同时进行多个验证性临床试验的非常早期的干预措施，在救护车或急诊科（艾德）。NETT已成功争取资金，并实施了四项积极招募的临床试验，其中两项利用知情同意例外（EFIC），其中一项已接近完成。其他几项试验正在与NETT内外的调查人员一起开发。在NETT启动的所有试验中，受试者累积均超出预期并在预算范围内。成功的运作可以归功于NETT组织和流程的效率。NETT的协调活动得到了两个NINDS合作协议的支持，分别是密歇根大学的临床协调中心（CCC）（U01 NS 056975）和南卡罗来纳州医科大学的生物统计学和流行病学（DBE）部的统计和数据管理中心（SDMC）（U01 NS 059041）。此外，17个学术中心（中心）参加了NETT，每个中心都得到了NINDS的R01资助。在第二个五年资助期内，委员会的目的是与参与该计划的各方保持合作关系，并继续为该计划进行的临床试验提供有效的数据管理支援和统计专业知识。我们还将探索临床试验设计的创新，包括适应性研究设计。