Neurological Emergencies Treatment Trials Network: Clinical Coordinating Center

描述（由申请人提供）：神经系统紧急情况，如中风、创伤性脑损伤、癫痫发作、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。在神经系统急症中进行有效的临床试验需要急诊医生、神经学家、神经外科医生和生物统计学家的协调网络。本提案是对NINDS RFA NS-06-002的回应，描述了我们将作为神经系统紧急情况治疗试验（NETT）网络的临床协调中心提供的特征、功能和协调。这一结构的关键要素将包括一个跨学科的研究人员团队，他们在进行紧急干预的临床试验方面具有特定的专业知识，一个轴辐式网络设计，承认在大型学术中心和社区医院急诊科招募患者的重要性，以及一个长期的网络承诺，以推进国家研究基础设施，因为它涉及到紧急疾病的跨学科研究。该项目的第一个目标是为NETT创建一个最佳的网络基础设施，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。所述的操作资源将使电子数据输入和自动筛选和识别研究参与者成为可能。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，以促进未来转化为临床实践。第二个目标是积极吸引临床医生参与临床研究，并为研究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，不断对人员进行培训和认证，并确保最佳地保护人体实验对象和良好的研究做法。最后，我们描述了两个临床试验，证明了NETT的能力。第一个是癫痫持续状态的院前治疗试验，比较肌内咪达唑仑和静脉注射劳拉西泮在院外快速控制癫痫发作的效果。第二项是一项随机、双盲、安慰剂对照的试验，旨在对创伤性脑损伤患者进行超早期孕酮治疗。

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.