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

本提案的目的是为SIREN研究项目创建一个由约翰霍普金斯急诊医学部（JHM DEM）组织的新临床中心（中心）。JHM Hub- and-Spoke网络由九个完全致力于Spoke的机构组成，能够从五个州和华盛顿的25个独特的临床站点招募人员。该网络的年度艾德人口普查访问次数超过160万次，其中少数民族、社会经济弱势群体和农村人口占很大比例。紧急医疗服务（EMS）系统与轴和辐条已致力于SIREN计划，通过直接参与研究与JHM轴和辐条网络进行。JHM DEM将利用丰富的临床研究经验和强大的机构研究环境，为国家SIREN计划做出直接和有意义的贡献，并改善神经系统，心脏，呼吸系统，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，在年度出版物和赠款、总研究经费、NIH经费和资助研究的总教师方面一直处于全国领先地位。迄今为止，JHM DEM已经招募了数万名患者参与前瞻性急诊护理研究。JHM轴辐式网络将通过以下具体目标为SIREN取得成功：目标1：创建一个中心网络管理结构，确保SIREN临床试验的高效和有效招募和执行。创新的集线器网络设计将允许快速扩展，以满足个人SIREN试验需求。促进有效和高效招募、方案执行、数据输入和质量保证的工具将在JHM SIREN网络中传播。目标二。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。第二个主要重点将是包容性和妇女和代表性不足的种族，民族，性别和性别少数群体在我们的中心和辐射研究团队的多站点辅导。目标3。培养急诊临床试验研究的未来领导者。我们的中心网络将作为初级急救护理调查员（居民，研究员，初级教师，护士，EMS提供者）的培训环境。初级研究者将通过中心开发的研讨会和教学法，SIREN试验的执行以及参与技术工作组（包括专注于优化试验实施和开发新试验提案的技术工作组），获得临床试验研究方面的指导经验。这些目标将通过一个三方枢纽组织结构来实现，该结构包括（1）行政核心，（2）治理核心，以及（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.