Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)

该提案的目的是创建一个新的临床中心（Hub），由约翰霍普金斯医学院急诊医学系（JHM DEM）组织，用于SIREN研究项目。JHM Hub- and-Spoke网络由九个完全承诺的Spoke机构组成，有能力从五个州和华盛顿特区的超过25个独特的临床站点招聘。该网络的年度ED普查超过160万次，具有少数民族，社会经济弱势群体和农村人口的强大代表性。与Hub and spoke相关的紧急医疗服务（EMS）系统通过直接参与JHM Hub-and- spoke网络进行的研究，致力于SIREN计划。JHM DEM将利用广泛的临床研究经验和强大的机构研究环境，为国家SIREN项目做出直接和有意义的贡献，并改善神经、心脏、呼吸、血液学和创伤性疾病患者的预后。自1985年以来，JHM DEM一直从事临床研究，并且在年度出版物和资助，研究资金总额，NIH资助和资助研究的总教师人数方面一直处于全国领先地位。迄今为止，JHM DEM已经在前瞻性急诊护理研究中招募了数万名患者。JHM中心辐状网络将通过以下具体目标实现SIREN的成功：目标1：创建一个中心网络管理结构，保证高效和有效地招募和执行SIREN临床试验。创新的Hub-of-Hubs网络设计将允许快速扩展，以满足个人SIREN试验需求。促进有效和高效的招募、协议执行、数据输入和质量保证的工具将在JHM SIREN网络中传播。目标2。促进SIREN临床试验和临床研究领导的多样性。改善服务不足社区的健康结果是JHM的核心临床和研究使命；促进这些群体在SIREN研究中的代表性将是JHM SIREN中心的主要重点。第二个重点将是在我们的中心辐射式研究团队中对女性和未被充分代表的种族、民族、性和性别少数群体进行包容和多站点指导。目标3。培养急诊临床试验研究的未来领导者。我们的中心网络将为初级急救调查员（住院医师、研究员、初级教师、护士、EMS提供者）提供培训环境。初级研究人员将通过Hub开发的研讨会和教学、SIREN试验的执行以及参与技术工作组，包括那些专注于优化试验实施和开发新试验建议的技术工作组，获得临床试验研究的指导经验。这些目标将通过三方中心组织结构来执行，该组织结构包括(1)管理核心，(2)治理核心，和(3)技术工作组。

The objective of this proposal is to create a new Clinical Center (Hub) organized by the Johns Hopkins Medicine Department of Emergency Medicine (JHM DEM) for the SIREN research program. The JHM Hub- and-Spoke network is comprised of nine fully committed Spoke institutions with the capacity to recruit from more than 25 unique clinical sites across five states and Washington, DC. Annual ED census of the network exceeds 1.6 million visits with strong representation of minority, socioeconomically disadvantaged and rural populations. Emergency medical services (EMS) systems associated with Hub and spokes have committed to the SIREN program through direct participation in research conducted with the JHM Hub-and-Spoke network. The JHM DEM will leverage extensive clinical research experience a robust institutional research environment to make immediate and meaningful contributions to the national SIREN program and to improve outcomes for patients with neurologic, cardiac, respiratory, hematologic, and traumatic conditions. The JHM DEM has been continuously engaged in clinical research since 1985 and is a consistent national leader in annual publications and grants, total research funding, NIH funding, and total faculty with funded research. To date, the JHM DEM has enrolled tens of thousands of patients in prospective emergency care research. The JHM Hub-and-Spoke network will achieve success for SIREN through the following Specific Aims: Aim 1: Create a Hub network administrative structure that guarantees efficient and effective recruitment for and execution of SIREN clinical trials. An innovative Hub-of-Hubs network design will allow for rapid scalability to meet individual SIREN trial needs. Tools to facilitate effective and efficient recruitment, protocol execution, data entry, and quality assurance will be disseminated across the JHM SIREN network. Aim 2. Promote diversity of inclusion in SIREN clinical trials and clinical research leadership. Improving health outcomes for underserved communities is a core clinical and research mission of JHM; promoting representation of these groups in SIREN studies will be a major focus of the JHM SIREN Hub. A second major focus will be inclusion and multi-site mentorship of women and underrepresented racial, ethnic, sexual, and gender minorities within our Hub-and-Spoke research team. Aim 3. Train future leaders in emergency care clinical trials research. Our Hub network will serve as a training environment for junior emergency care investigators (residents, fellows, junior faculty, nurses, EMS providers). Junior investigators will gain mentored experience in clinical trials research through workshops and didactics developed by the Hub, execution of SIREN trials, and participation in technical working groups including those focused on optimizing trial implementation and development of new trial proposals. These aims will be executed through a tripartite Hub organizational structure that includes (1) an Administrative Core, (2) a Governance Core, and (3) Technical Working Groups.