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：
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
项目类别：
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

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

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项目摘要

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（Siren）策略的总体目标是改善通过识别最早给予的有效治疗的患者的结果护理阶段。紧急情况，例如心肌梗塞，心脏骤停，创伤性伤害，包括大脑和脊髓损伤以及癫痫发作会引起明显的发病率和死亡率人类苦难和医疗保健支出的条款。临床前和翻译的研究表明有一个非常狭窄的机会之窗，在紧急情况下进行新的治疗方法最佳有效，在紧急情况下进行研究表现出独特的务实临床研究人员面临的挑战。在这些条件下的有效临床试验需要协调网络急诊医生，外科医生，心脏病学家，强化主义者，神经科医生和生物统计学家。该提议，在对RFANS16014的响应描述了我们将作为临床提供的功能，功能和协调警笛网络协调中心。该结构的关键要素将包括一个跨学科在进行紧急干预临床试验方面具有特定专业知识的研究人员团队 Hubbandspoke网络设计承认将患者纳入急性环境的重要性，并且长期网络致力于推进国家研究基础设施的承诺急性疾病和伤害的跨学科研究。该项目旨在创建一个连贯，协作的多学科的紧急临床试验社区，潜水员和包容性。网络将招募，有效地执行并广泛传播最科学和临床上重要的试验提高神经，心脏，呼吸系统，血液学和创伤患者的急诊护理紧急情况。在5年赠款期间，在ED和院前环境中至少进行了4个大型简单试验开始。该网络旨在通过探索创新来改变紧急研究企业临床试验设计（包括基于自适应和注册方法），通过更好和更早的参与患者利益相关者在试验计划中以及通过实施和执行试验的创造性改进。