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: 10246475
• 负责人: WILLIAM G BARSAN
• 金额: $ 60.6万
• 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 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10246475
• 关键词: Accident and Emergency department; Acute; Ambulances; Applications Grants; Brain; Budgets; Cardiac; Caring; Case Report Form; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Coma; Communities; Community Trial; Conduct Clinical Trials; Contracts; Data; Development; Devices; Early Intervention; Effectiveness; Elements; Emergency Care; Emergency Department Physician; Emergency Situation; Emergency research; Emergency treatment; Enrollment; Ensure; Funding; Goals; Grant; Healthcare; Heart; Heart Arrest; Hematology; Human; Informed Consent; Injury; Institutes; Interdisciplinary Study; Intervention; Investigation; Leadership; Lung; Methods; Mission; Morbidity - disease rate; Myocardial Infarction; Neurologic; Neurological emergencies; Neurologist; Neurosurgeon; Occupational activity of managing finances; Online Systems; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Physicians; Pre-hospital setting; Principal Investigator; Protocols documentation; Registries; Research; Research Infrastructure; Research Personnel; Resources; Resuscitation; Seizures; Spinal Cord; Structure; Surgeon; Symptoms; System; Time; Translational Research; Translations; Trauma; Traumatic injury; United States National Institutes of Health; Voice; Work; acute care; base; confirmatory clinical trial; cost; data management; design; effective therapy; emergency settings; expectation; experience; improved; improved outcome; innovation; mortality; multidisciplinary; novel; patient engagement; pre-clinical research; quality assurance; recruit; respiratory; response; screening; spinal cord and brain injury; success; treatment trial

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.

紧急护理临床试验网络创新策略 (SIREN) 的总体目标是通过在护理的最早阶段确定有效的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，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。该提案响应 RFANS16014，描述了我们将作为 SIREN 网络临床协调中心提供的特性、功能和协调。该结构的关键要素将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网络设计以及一个致力于推进国家研究基础设施的长期网络承诺，因为它与急性疾病和损伤的跨学科研究有关。该项目旨在创建一个连贯、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。在 5 年资助期内，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（包括基于适应性和注册的方法）、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。