Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Clinical Coordinating Center (CCC)

创新紧急护理临床试验网络(SIREN)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患有急性疾病和损伤的患者的结局。心肌梗死、心脏骤停、包括脑和脊髓损伤在内的创伤性损伤以及癫痫发作等紧急情况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。临床前和转化性研究表明，在紧急情况下进行新的治疗方法具有最佳效果的机会窗口非常狭窄，在紧急情况下进行研究对临床研究人员提出了独特的实用挑战。在这些情况下进行有效的临床试验需要一个由急诊医生、外科医生、心脏病专家、强化医生、神经学家和生物统计学家组成的协调网络。这份提案是对RFANS16014的回应，描述了我们作为SIREN网络的临床协调中心将提供的特点、功能和协调。这一结构的关键要素将包括一个在进行紧急干预临床试验方面具有具体专门知识的跨学科调查人员团队、一个中心辐射型网络设计，该网络设计承认在急症环境中招收患者的重要性，以及一个长期网络承诺，以促进与急性疾病和损伤的跨学科研究有关的国家研究基础设施。该项目旨在创建一个连贯的、协作的、多学科的、多样化和包容性的紧急临床试验社区。该网络将招募、有效执行和广泛传播最具科学和临床重要性的试验，以推进对患有神经科、心脏、呼吸系统、血液和创伤急症患者的紧急护理。在5年的资助期内，将在急诊室和院前环境中启动至少4项大型、简单的试验。该网络旨在通过探索临床试验设计的创新(包括适应性和基于注册的方法)、更好地和更早地让患者利益相关者参与试验规划以及通过创造性地改进试验的实施和执行，来改变紧急研究企业。

The overall goal of the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) is to improve the outcome of patients suffering acute illness and injury by identifying effective treatments given in the earliest stages of care. Emergency conditions such as myocardial infarction, cardiac arrest, traumatic injury including brain and spinal cord injury, and seizures cause significant morbidity and mortality and exact a high cost in terms of human suffering and health care spending. Preclinical and translational research has demonstrated that there is a very narrow window of opportunity in which novel treatments for emergency conditions are optimally effective, and that conducting research in the emergency setting presents unique pragmatic challenges to clinical investigators. Effective clinical trials in these conditions require a coordinated network of emergency physicians, surgeons, cardiologists, intensivists, neurologists and biostatisticians. This proposal, in response to RFANS16014 describes the features, functions and coordination we will provide as the Clinical Coordinating Center for the SIREN 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 the acute setting, and a long term network commitment to advancing the national research infrastructure as it relates to the interdisciplinary study of acute illness and injury. This project aims to create a coherent, collaborative, multidisciplinary emergency clinical trials community that is diverse and inclusive. The network will recruit, efficiently perform, and widely disseminate the most scientifically and clinically important trials necessary to advance the emergency care of patients with neurologic, cardiac, respiratory, hematologic and trauma emergencies. At least 4 large, simple trials in the ED and pre-hospital setting over the 5 year grant period will be initiated. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs (including adaptive and registry based methods), by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.