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

紧急护理临床试验网络：紧急护理临床试验网络 (SIREN) 创新策略

基本信息

批准号：
10552366
负责人：
GABOR D KELEN
金额：
$ 46.03万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-01 至 2028-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10552366
关键词：
Accident and Emergency department Cardiac Censuses Clinical Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Data Development Economically Deprived Population Educational workshop Emergency Care Emergency Medicine Emergency medical service Emergency research Enrollment Ensure Environment Equity Ethnic Origin Faculty Funding Future Grant Health Health system Heart failure Hematology Individual Institution Lead Leadership Maryland Medicine Mentors Mentorship Minority Mission Multicenter Trials Neurologic Nurses Outcome Patient Recruitments Patient-Focused Outcomes Patients Population Positioning Attribute Principal Investigator Productivity Protocols documentation Publications Race Records Research Research Personnel Rural Population Sepsis Sexual and Gender Minorities Site Structure System Testing Training Underrepresented Minority Underrepresented Populations United States National Institutes of Health Urban Population Visit Washington Woman clinical center clinical research site design diversity and inclusion ethnic minority experience flexibility gender minority improved improved outcome inner city innovation lung failure novel therapeutics organizational structure programs prospective quality assurance racial minority recruit respiratory response service providers sexual minority socioeconomic disadvantage success tool underserved community working group

项目摘要

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.

该提案的目标是为 SIREN 研究计划创建一个由约翰霍普金斯大学急诊医学部 (JHM DEM) 组织的新临床中心 (Hub)。 JHM Hub-and-Spoke 网络由 9 个全力投入的 Spoke 机构组成，能够从五个州和华盛顿特区的超过 25 个独特的临床中心进行招募。该网络的年度 ED 普查访问量超过 160 万次，其中少数民族、社会经济弱势群体和农村人口具有很强的代表性。与中心辐射相关的紧急医疗服务 (EMS) 系统已通过直接参与 JHM 中心辐射网络进行的研究来致力于 SIREN 计划。 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 计划做出直接且有意义的贡献，并改善神经、心脏、呼吸、血液和创伤性疾病患者的治疗结果。 JHM DEM 自 1985 年以来一直致力于临床研究，在年度出版物和拨款、研究经费总额、NIH 经费以及受资助研究的师资总数方面始终处于全国领先地位。迄今为止，JHM DEM 已招募了数万名患者参加前瞻性紧急护理研究。 JHM Hub-and-Spoke 网络将通过以下具体目标为 SIREN 取得成功：目标 1：创建一个 Hub 网络管理结构，保证 SIREN 临床试验的高效和有效招募和执行。创新的 Hub-of-Hubs 网络设计将实现快速可扩展性，以满足各个 SIREN 试验的需求。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力的多样性。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。第二个重点是我们中心辐射研究团队中对女性和代表性不足的种族、民族、性别和性别少数群体的包容性和多地点指导。目标 3. 培训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紧急护理调查人员（住院医师、研究员、初级教员、护士、EMS 提供者）提供培训环境。初级研究人员将通过中心举办的研讨会和教学、执行 SIREN 试验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。这些目标将通过三方中心组织结构来执行，该组织结构包括 (1) 行政核心、(2) 治理核心和 (3) 技术工作组。