Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center

紧急护理临床试验网络 (SIREN) 创新策略 - 数据协调中心

基本信息

批准号：
10550413
负责人：
VALERIE L DURKALSKI
金额：
$ 43.38万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
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：
2023-01-15 至 2028-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10550413
关键词：
Accident and Emergency department Ancillary Study Applications Grants Attenuated Authorization documentation Budgets COVID-19 COVID-19 pandemic Cardiac Cardiovascular system Caring Case Report Form Clinical Clinical Data Clinical Investigator Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Communication Conduct Clinical Trials Creativeness Data Data Collection Data Coordinating Center Data Reporting Data Set Development Diagnosis Disease Early Intervention Effectiveness Emergency Care Emergency Department Physician Emergency Situation Emergency research Ensure Event FDA approved Funding Goals Grant Guidelines Health Sciences Hematology Hospital Departments Individual Information Management Informed Consent Infrastructure Injury Intensive Care Units Intervention Investigation Manuscripts Medical Mission Monitor Multicenter Trials Neurologic Neurological emergencies Neurologist Neurology Neurosurgeon Online Systems Outcome Patient-Focused Outcomes Patients Preparation Principal Investigator Productivity Public Health Publications Quality Control Regulation Reporting Research Research Design Research Personnel Resources Resuscitation Risk Role Site South Carolina Specific qualifier value Standardization Status Epilepticus System Translational Research Trauma Traumatic Brain Injury United States National Institutes of Health Universities Work authority body system central database clinical research site confirmatory clinical trial cost data integration data management data quality data sharing data standards design distributed data effective therapy emergency settings expectation experience improved improved outcome innovation multidisciplinary novel operation pandemic disease participant enrollment patient engagement pragmatic trial pre-clinical research protocol development quality assurance respiratory response spinal cord and brain injury success support network tool treatment trial trial design trial enrollment trial planning

项目摘要

Emergency care often determines the patient outcome as it is critical to make accurate, timely diagnoses and interventions during the early stages of the injury or disease. The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) was created by the NIH to enable the investigation of different emergency care treatments spanning across organ systems and diseases without duplication of effort, thereby minimizing start- up costs and promoting economies of scale. The purpose of the Data Coordinating Center (DCC) for SIREN is to provide a comprehensive data management and statistical infrastructure to support the network’s goal of conducting high quality clinical trials that will improve outcomes for patients with neurologic, cardiac, respiratory, hematologic and trauma emergency events. This renewal application, in response to RFA-NS-22-013, describes the features, functions and coordination we will continue to provide as the DCC for the SIREN Network. The DCC’s role is to establish a collaborative relationship with all parties involved in the Network and provide efficient and standardized central data management that yields high quality data, provide statistical support in the planning and execution of the clinical trials, prepare and disseminate trial reports for the various stakeholders and facilitate data sharing. To this end, the Data Coordination Unit (DCU) at the Medical University of South Carolina has developed a web-based comprehensive integrated data and project management system, WebDCU™, that enables distributed data entry from the participating clinical sites with extensive data quality control. The DCU also provides the necessary tools to efficiently manage operational activities across multiple trials, while ensuring compliance with FDA regulations and guidelines. Using the WebDCU system, we have developed, implemented and maintained a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical data. In addition, the WebDCU™ incorporates trial management information that provides full support for all study operational activities in SIREN. In collaboration with the individual study Principal Investigator and our partners of SIREN (CCC, Hubs, Governance Committees), the DCU will continue to: contribute to the innovative and efficient protocol development (including study design and case report form development); oversee data quality; generate reports for the DSMB, regulatory parties and the study teams; conduct interim and final analysis and dissemination of study results via presentations and publications; and create public use datasets for data sharing. SIREN initiated 5 large, simple multicenter trials over the previous 5 year grant period and will initiate at least 4 more in the next grant period. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs, by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.

紧急护理通常决定患者的治疗结果，因为在受伤或疾病的早期阶段进行准确、及时的诊断和干预至关重要，NIH 创建了紧急护理临床试验网络创新策略 (SIREN)，以便进行调查。 SIREN 数据协调中心 (DCC) 的目的是提供全面的数据管理和服务，涵盖跨器官系统和疾病的不同紧急护理治疗，无需重复工作，最大限度地降低启动成本并促进规模经济。统计基础设施，以支持网络进行高质量临床试验的目标，从而改善神经、心脏、呼吸、血液和创伤紧急事件患者的结果。此更新应用程序响应 RFA-NS-22-013，描述了这些功能。我们将继续作为 SIREN 网络的 DCC 提供功能和协调。 DCC 的作用是与网络中涉及的各方建立协作关系，提供高效、标准化的中央数据管理，从而产生高质量的数据，提供统计支持。在南卡罗来纳医科大学的数据协调部门 (DCU) 开发了一个基于网络的综合集成数据和平台，旨在规划和执行临床试验，为各利益相关者准备和传播试验报告并促进数据共享。项目管理系统 WebDCU™，支持从参与的临床站点进行分布式数据输入，并进行广泛的数据质量控制。DCU 还提供必要的工具来有效管理多个试验的操作活动，同时确保遵守 FDA 法规和指南。 WebDCU系统，我们开发、实施和维护了一个中央数据库，可简化数据收集、处理和临床数据监测的管理并最大限度地提高效率。此外，WebDCU™ 还包含试验管理信息，为所有研究运营活动提供全面支持。 SIREN。DCU 将与个别研究首席研究员和我们的 SIREN 合作伙伴（CCC、中心、治理委员会）合作：促进创新和高效的方案开发（包括研究设计和病例报告表开发）；数据质量；为 DSMB、监管方和研究团队生成报告；通过演示和出版物进行研究结果的中期和最终分析；并创建用于数据共享的公共数据集。该网络将在下一个资助期内启动至少 4 个项目，旨在通过探索临床试验设计的创新、让患者利益相关者更好、更早地参与试验计划，以及通过创新性改进来改变紧急研究企业。实施和进行试验。