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: 9757540
• 负责人: WILLIAM G BARSAN
• 金额: $ 24.33万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757540
• 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; base; 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

Project Summary/Abstract . 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 hub­and­spoke 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 prehospital 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 registry­based methods), by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.

项目摘要/摘要。 紧急护理临床试验网络创新策略 (SIREN) 的总体目标是改善 通过确定尽早给予的有效治疗来确定患有急性疾病和受伤的患者的结果 紧急情况，如心肌梗塞、心脏骤停、外伤，包括护理阶段。 脑和脊髓损伤以及癫痫发作会导致严重的发病率和死亡率，并导致高昂的治疗费用 临床前和转化研究已经证明了人类痛苦和医疗保健支出。 紧急情况的新疗法的机会之窗非常狭窄 最佳效果，并且在紧急情况下进行研究具有独特的实用性 在这些情况下进行有效的临床试验需要一个协调的网络。 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。 对 RFANS16014 的回复描述了我们将提供的临床特征、功能和协调 SIREN 网络协调中心该结构的关键要素将包括一个跨学科的机构。 具有进行紧急干预临床试验的特定专业知识的研究人员团队， hubandspoke 网络设计承认在急性环境中招募患者的重要性，以及 致力于推进国家研究基础设施的长期网络承诺 该项目旨在建立一个连贯的、协作的、关于急性疾病和损伤的跨学科研究。 该网络将招募多元化和包容性的多学科紧急临床试验社区。 有效地进行并广泛传播最科学和临床上最重要的试验 推进神经、心脏、呼吸、血液和创伤患者的紧急护理 在 5 年拨款期内，将在急诊科和院前环境中进行至少 4 项大型、简单的试验。 该网络旨在通过探索创新来改造应急研究企业。 临床试验设计（包括适应性和基于注册的方法），通过更好和更早的参与 试验计划中的患者利益相关者，以及实施和执行试验的创造性改进。