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: 8188733
• 负责人: VALERIE L DURKALSKI
• 金额: $ 109.89万
• 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/8188733
• 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. PUBLIC HEALTH RELEVANCE: Ambulances and EDs are difficult venues in which to perform clinical trials, but it is in the earliest phases of care that neuroprotective and other critical interventions are most likely to be effective. The NETT is tasked with performing in these venues confirmatory trials with readily applicable results that can immediately impact patient care. The NETT has proven its capabilities to carry out this work, and its continued effort is paramount to efficiently and simultaneously implement these important multicenter trials.

描述（由申请人提供）：神经系统紧急治疗试验（NETT）网络的总体目标是通过确定最早的护理阶段给予的有效治疗方法来改善患有急性神经疾病和损伤的患者的结局。在开发NetT时，Ninds认识到，临床前和转化的研究表明，有一个非常狭窄的机会窗口，在这种机会窗口中，神经系统紧急情况的新型治疗方法在紧急情况下进行研究非常有效，并且在紧急情况下进行研究给临床研究人员带来了独特的务实挑战。在过去的四年中，Nett已被证明是一个能够选择，开发和同时进行多次确认性临床试验的平台，以对救护车或急诊室（ED）提供的非常早期的干预措施进行多次确认临床试验。 Nett已成功竞争资金，并实施了四项积极入学的临床试验，其中两项利用了知情同意书（EFIC）的例外，其中一项已经接近完成。其他几项试验正在与Nett内部和外部的调查人员一起开发。在Nett发起的所有试验中，主题应为预期和预算。成功的操作可以归因于NetT组织和流程的效率。 NETT的协调活动得到了密歇根大学（U01 NS056975）的临床协调中心（CCC）的两项NINDS合作协议的支持，并在Biostaticsistical and Peremiological and Peremiologicy（DBE）（DBE）的统计和数据管理中心（SDMC）在South Carolina of South Carolina（U01 NS1 NS）（U01 NS）（U01 NS）（U01 NS 1 NS）（U01 NS）。此外，有17个学术中心（HUB）参加了Nett的Nett，并向Ninds的每个中心提供了R01赠款。在第二个五年赠款期间，SDMC的目的是维持与净纳特参与各方的协作关系，并继续提供有效的数据管理支持和统计专业知识，以供NETT进行临床试验。我们还将探索包括自适应研究设计在内的临床试验设计中的创新。 公共卫生相关性：救护车和ED是进行临床试验的困难场所，但在最早的护理阶段，神经保护性和其他关键干预措施最有可能有效。 NetT的任务是在这些场所进行确认试验中进行，并容易适用的结果可以立即影响患者护理。 Nett证明了其执行这项工作的能力，其持续的努力对于有效，同时实施这些重要的多中心试验至关重要。