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)

• 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
• 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

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.

创新急救临床试验网络（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急性疾病和损伤患者的预后。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状况导致显著的发病率和死亡率，并且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，有一个非常狭窄的机会窗口，其中许多新的治疗紧急情况是最有效的，并在紧急情况下进行研究提出了独特的务实挑战，临床研究者。在这些条件下进行有效的临床试验需要急诊医生、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的协调网络。作为对RFA-NS-22-014的回应，本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性、功能和协调。这一持续结构的关键要素包括一个跨学科的研究人员团队，他们在紧急干预措施的临床试验方面具有特定的专业知识，一个中心辐射网络设计，承认在急性环境中招募患者的重要性，以及一个长期的网络承诺，以推进国家研究基础设施，因为它涉及急性疾病和损伤的跨学科研究。该项目将继续创建和维护一个一致的，协作的，多学科的紧急临床试验社区，这是多样化和包容性的。该网络将招募、有效执行和广泛传播最具科学和临床意义的必要试验，以促进神经、心脏、呼吸、血液和创伤急诊患者的急诊护理。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启动至少4项。该网络旨在通过探索临床试验设计的创新，通过患者利益相关者更好和更早地参与试验计划，以及通过实施和执行试验的创造性改进，来改变紧急研究企业。