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

急诊护理临床试验网络创新战略（SIREN）的总体目标是通过确定在护理的早期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果。心肌梗塞、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代价。临床前研究和转化研究表明，许多紧急情况的新治疗方法达到最佳效果的机会窗口非常狭窄，而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。在这种情况下，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、重症监护医生、神经科医生和生物统计学家组成的协调网络。根据RFA-NS-22-014的要求，这份更新申请描述了我们将继续作为SIREN网络的临床协调中心提供的特征、功能和协调。这一正在进行的结构的关键要素包括一个具有紧急干预临床试验专门知识的跨学科研究团队，一个承认在急性环境中招募患者重要性的中心辐射型网络设计，以及一个长期致力于推进国家研究基础设施的网络，因为它与急性疾病和损伤的跨学科研究有关。该项目继续创建和维持一个连贯、协作、多学科、多样化和包容性的紧急临床试验社区。该网络将招募、有效执行并广泛传播最科学和临床重要的试验，以推进神经、心脏、呼吸、血液和创伤紧急情况患者的急诊护理。SIREN在过去5年的资助期内启动了5项大型、简单的多中心试验，并将在下一个资助期内至少启动4项试验。该网络旨在通过探索临床试验设计方面的创新，通过更好和更早地让患者利益攸关方参与试验规划，以及通过创造性地改进试验的实施和执行，改变应急研究事业。

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. Pre-clinical and translational research has demonstrated that there is a very narrow window of opportunity in which many 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 renewal application, in response to RFA-NS-22-014 describes the features, functions and coordination we will continue to provide as the Clinical Coordinating Center for the SIREN network. The key elements of this ongoing structure 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 continues to create and maintain 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. SIREN initiated 5 large, simple multicenter trials over the previous 5 year grant period, and will initiate at least 4 more in the next grant period. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs, by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.