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：
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
项目类别：
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

项目摘要

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.

创新急诊临床试验网络（SIREN）策略的总体目标是通过确定在最早的护理阶段给予的有效治疗方法来改善患者的结果。紧急情况，例如心肌梗塞，心脏骤停，包括大脑和脊髓损伤在内的创伤性损伤以及癫痫发作会导致明显的发病率和死亡率，并且在人类痛苦和医疗保健支出方面造成了高昂的成本。临床前和翻译研究表明，有一个非常狭窄的机会窗口，在紧急情况下进行新的治疗方法是最佳有效的，并且在紧急情况下进行研究给临床研究者带来了独特的务实挑战。在这些条件下的有效临床试验需要协调的急诊医师，外科医生，心脏病学家，强化主义者，神经病学家和生物统计学家的网络。该提案对RFANS16014的回应描述了我们将作为警笛网络的临床协调中心提供的功能，功能和协调。该结构的关键要素将包括一个跨学科的调查人员团队，该团队在进行紧急干预的临床试验中具有特定专业知识，枢纽和讲话网络设计，该设计承认让患者进入急性环境以及长期网络承诺的重要性促进国家研究基础设施，因为它与急性疾病和伤害的跨学科研究有关。该项目旨在创建一个连贯，协作，多学科的紧急临床试验社区，该试验多样性和包容性。该网络将招募，有效地执行并广泛传播最科学和临床上重要的试验，以促进神经，心脏，呼吸道，血液学和创伤紧急情况的患者的急诊护理。在5年赠款期内，在ED和院前环境中至少进行了4个大型简单试验。该网络旨在通过探索临床试验设计中的创新（包括基于自适应和注册表的方法），通过更好和更早的患者利益相关者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。