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

• 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
• 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

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结局，因为在受伤或疾病的早期阶段做出准确、及时的诊断和干预至关重要。创新紧急护理临床试验网络的战略(SIREN)是由美国国立卫生研究院创建的，目的是能够调查跨越器官系统和疾病的不同紧急护理治疗，而不会重复工作，从而将启动成本降至最低，并促进规模经济。SIREN数据协调中心(DCC)的目的是提供全面的数据管理和统计基础设施，以支持该网络进行高质量临床试验的目标，从而改善神经系统、心脏、呼吸、血液和创伤紧急事件患者的预后。本续订申请是对RFA-NS-22-013的回应，描述了我们将作为SIREN网络的DCC继续提供的特点、功能和协调。DCC的作用是与网络中涉及的所有各方建立合作关系，提供高效和标准化的中央数据管理，以产生高质量的数据，在临床试验的规划和执行中提供统计支持，为各种利益相关者准备和传播试验报告，并促进数据共享。为此，南卡罗来纳医科大学的数据协调单位开发了一个基于网络的综合数据和项目管理系统WebDCU™，该系统能够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还提供了必要的工具，以有效管理多个试验的操作活动，同时确保遵守FDA的法规和指南。使用WebDCU系统，我们开发、实施和维护了一个中央数据库，该数据库简化并最大限度地提高了临床数据收集、处理和监控的管理效率。此外，WEBDCU™包含试验管理信息，为SIREN中的所有研究操作活动提供全面支持。与个人研究首席调查员和SIREN(CCC、中心、治理委员会)的合作伙伴合作，DCU将继续：为创新和高效的方案开发(包括研究设计和案例报告表格开发)做出贡献；监督数据质量；为DSMB、监管各方和研究团队生成报告；通过演示和出版物对研究结果进行中期和最终分析和传播；并创建公共使用数据集，用于数据共享。SIREN在之前的5年资助期内启动了5个大型、简单的多中心试验，并将在下一个资助期至少再启动4个。该网络旨在通过探索临床试验设计的创新，通过更好地和更早地让患者利益相关者参与试验规划，以及通过在实施和执行试验方面进行创造性改进，来改变紧急研究企业。