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) 的策略 - 临床协调中心 (CCC)

基本信息

批准号：
10550501
负责人：
WILLIAM G BARSAN
金额：
$ 77.88万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-15 至 2028-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10550501
关键词：
Accident and Emergency department Acute Ambulances Ancillary Study Applications Grants Attenuated Blood Brain Budgets COVID-19 COVID-19 pandemic Cardiac Caring Clinical Clinical Investigator Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Coma Community Trial Conduct Clinical Trials Contracts Creativeness Critical Care Data Development Early Intervention Effectiveness Elements Emergency Care Emergency Department Physician Emergency Situation Emergency research Emergency treatment Enrollment Ensure FDA approved Funding Goals Grant Healthcare Heart Heart Arrest Hematology Human Information Technology Informed Consent Injury Intensive Care Units Interdisciplinary Study International Intervention Investigation Leadership Lung Methods Mission Morbidity - disease rate Multi-Institutional Clinical Trial Multicenter Trials Myocardial Infarction Neurologic Neurological emergencies Neurologist Neurosurgeon Online Systems Outcome Patient Care Patient-Focused Outcomes Patients Physicians Pre-hospital setting Principal Investigator Process Productivity Research Research Infrastructure Research Personnel Resources Resuscitation Seizures Site Spinal Cord Structure Surgeon Symptoms Translational Research Translations Trauma Traumatic injury United States National Institutes of Health Work acute care clinical trial enrollment confirmatory clinical trial cost data management design effective therapy electronic consent emergency settings expectation experience improved improved outcome innovation mortality multidisciplinary novel pandemic disease participant enrollment patient engagement pre-clinical research quality assurance recruit respiratory response screening spinal cord and brain injury success treatment trial trial planning

项目摘要

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.

紧急护理临床试验网络创新策略 (SIREN) 的总体目标是通过确定在护理的最早阶段提供的有效治疗方法来改善患有急性疾病和受伤的患者的结果。诸如心肌梗塞、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导致显着的发病率和死亡率，并在人类痛苦和医疗保健支出方面造成高昂的成本。临床前和转化研究表明，许多针对紧急情况的新疗法发挥最佳效果的机会窗口非常狭窄，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。在这些情况下进行有效的临床试验需要一个由急诊科医生、外科医生、心脏病专家、重症医生、神经科医生和生物统计学家组成的协调网络。此续订申请响应 RFA-NS-22-014，描述了我们将作为 SIREN 网络临床协调中心继续提供的特性、功能和协调。这一持续结构的关键要素包括一个由在紧急干预临床试验方面具有特定专业知识的跨学科研究人员团队、一个承认在急性环境下招募患者重要性的中心辐射型网络设计以及长期计划。网络致力于推进国家研究基础设施，因为它涉及急性疾病和伤害的跨学科研究。该项目将继续创建和维护一个连贯、协作、多学科、多元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科学和临床上最重要的试验，以促进对神经、心脏、呼吸、血液和创伤紧急情况患者的紧急护理。 SIREN 在之前的 5 年资助期内启动了 5 项大型、简单的多中心试验，并将在下一个资助期内启动至少 4 项。该网络旨在通过探索临床试验设计的创新、让患者利益相关者更好、更早地参与试验计划以及在实施和执行试验方面进行创造性改进，来转变应急研究企业。