Neurological Emergencies Treatment Trials Network: Clinical Coordinating Center

描述(由申请人提供)：神经急症，如中风、创伤性脑损伤、癫痫、脊髓损伤、脑膜炎和其他疾病，会导致严重的发病率和死亡率，并在人类痛苦和医疗保健支出方面造成高昂的成本。在神经紧急情况下进行有效的临床试验需要一个由急诊医生、神经科医生、神经外科医生和生物统计学家组成的协调网络。根据NINDS RFA NS-06-002的要求，这份建议书描述了我们作为神经急症治疗试验(NETT)网络的临床协调中心的特点、功能和协调。这一结构的关键要素将包括在进行紧急干预的临床试验方面具有特定专业知识的跨学科研究人员团队，承认在大型学术中心和社区医院急诊科招收患者的重要性的轴辐式网络设计，以及在与紧急疾病跨学科研究相关的情况下推进国家研究基础设施的长期网络承诺。该项目的第一个目标是为NETT创建一个优化的网络基础设施，以促进和进行高质量的大型简单试验。我们建议创新地使用技术来协助临床试验的管理、实施和质量保证。所述的业务资源将使电子数据录入和研究参与者的自动筛选和身份识别成为可能。临床协调中心将包括一个远程医疗股和一个成果评估股。临床翻译股将协助设计和进行试验，以便于将来将其转化为临床实践。第二个目标是积极吸引临床医生参与临床研究，并为调查人员和协调员提供全面和持续的教育。教育/培训股将利用多媒体材料为人员提供持续的培训和认证，并确保最佳地保护人类主体和良好的研究做法。最后，我们描述了两个证明NETT能力的临床试验。第一项是对癫痫持续状态的院前治疗试验，比较肌肉注射咪达唑仑和静脉注射劳拉西泮在院外环境下快速控制癫痫发作的效果。第二个将是一项随机、双盲、安慰剂对照的超早期黄体酮治疗创伤性脑损伤患者的试验。

DESCRIPTION (provided by applicant): Neurological emergencies such as stroke, traumatic brain injury, seizures, spinal cord injury, meningitis and others conditions cause significant morbidity and mortality and exact a high cost in terms of human suffering and health care spending. Conducting effective clinical trials in neurological emergencies requires a coordinated network of emergency physicians, neurologists, neurosurgeons, and biostatisticians. This proposal, in response to NINDS RFA NS-06-002, describes the features, functions and coordination we will provide as the Clinical Coordinating Center for the Neurological Emergencies Treatment Trials (NETT) network. The key elements of this structure will include an interdisciplinary team of investigators with specific expertise in the conduct of clinical trials of emergency interventions, a hub-and-spoke network design that acknowledges the importance of enrolling patients in both large academic centers and community hospital emergency departments, and a long term network commitment to advancing the national research infrastructure as it relates to the interdisciplinary study of emergent illness. The first aim of the project is the creation of an optimal network infrastructure for NETT that promotes and conducts high quality, large simple trials. We propose the innovative use of technology to assist in the management, conduct and quality assurance of clinical trials. The operational resources described will enable electronic data entry and automated screening and identification of study participants. The Clinical Coordinating Center will include a Telemedicine Unit and an Outcomes Assessment Unit. A Clinical Translation Unit will assist in designing and conducting trials in a way that facilitates future translation into clinical practice. A second aim is to actively engage clinicians in clinical research and to provide comprehensive and ongoing education for investigators and coordinators. The Education/Training Unit will utilize multimedia materials to provide ongoing training and certification of personnel and ensure optimal protection of human subjects and good research practices. Finally, we describe two clinical trials which demonstrate the capability of NETT. The first is a pre-hospital treatment trial for status epilepticus comparing intramuscular midazolam to intravenous lorazepam for rapid control of seizures in the out-of-hospital setting. The second will be a randomized, double-blind, placebo-controlled trial of ultra-early progesterone in patients with traumatic brain injury.