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。 创新急诊临床试验网络战略(SIREN)的总体目标是改进 通过及早确定有效的治疗方法来确定急性疾病和损伤患者的转归 护理阶段。紧急情况，如心肌梗死、心脏骤停、创伤，包括 脑和脊髓损伤，以及癫痫发作会导致显著的发病率和死亡率，并在 关于人类苦难和医疗保健支出的条款。临床前和转化性研究表明 有一个非常狭窄的机会之窗，在这个窗口中，针对紧急情况的新治疗方法 最有效，在紧急情况下进行研究具有独特的实用性 临床研究人员面临的挑战。在这些条件下进行有效的临床试验需要一个协调的网络 急诊医生、外科医生、心脏病专家、重症医生、神经学家和生物统计学家。这项建议，在 对RFA-NS-16-014的回应描述了我们将作为临床提供的特性、功能和协调 警报网协调中心。这一结构的关键要素将包括一个跨学科 在进行紧急干预措施的临床试验方面具有特定专业知识的调查人员团队，a 轴辐式网络设计，承认在急诊环境中招募患者的重要性，以及 长期致力于推进国家研究基础设施，因为它与 急性疾病和损伤的跨学科研究。该项目旨在创建一个连贯、协作、 多学科紧急临床试验社区，是多样化和包容性的。电视网将招募， 有效地执行并广泛传播最具科学和临床重要性的试验 推进神经、心脏、呼吸、血液、创伤患者的急救 紧急情况。在5年的资助期内，在急诊室和院前环境中至少进行4项大型、简单的试验 被启动。该网络旨在通过探索以下方面的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)，通过更好和更早地参与 患者利益相关者参与试验计划，并在实施和执行试验方面进行创造性改进。