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.

紧急护理通常会决定患者的预后，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创建了创新急诊临床试验网络（SIREN）的策略，以实现跨器官系统和疾病的不同紧急护理治疗的投资，而无需重复努力，从而最大程度地减少了启动成本和促进规模的经济。 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，该试验将改善神经，心脏，呼吸，血液学，血液学和创伤紧急事件的患者的结果。该更新应用程序响应RFA-NS-22-013，描述了我们将继续作为警笛网络的DCC提供的功能，功能和协调。 DCC的作用是与参与网络的所有当事方建立合作关系，并提供高效和标准化的中央数据管理，从而产生高质量的数据，在临床试验的计划和执行中提供统计支持，为各种利益相关者准备和分发试验报告，并促进数据共享。为此，南卡罗来纳州医科大学的数据协调单元（DCU）开发了一个基于Web的综合数据和项目管理系统WebDCU™，该系统可以从具有广泛数据质量控制的参与临床站点中分布数据输入。 DCU还提供了必要的工具，可以在多个试验中有效管理运营活动，同时确保遵守FDA法规和准则。使用WebDCU系统，我们已经开发，实施和维护了一个中央数据库，该数据库简化并最大程度地提高了数据收集，处理和监视临床数据的效率。此外，WebDCU™成立了试验管理信息，该信息为警报器中的所有学习操作活动提供了全力支持。与个人研究的首席研究员和我们的警笛伙伴（CCC，枢纽，治理委员会）合作，DCU将继续：为创新和有效的协议开发（包括研究设计和案例报告表格开发）；监督数据质量；为DSMB，监管方和研究团队生成报告；通过演讲和出版物进行研究结果的临时和最终分析以及分散；并创建用于数据共享的公共使用数据集。 Siren在上5年的赠款期间发起了5项大型简单多中心试验，并将在下一个赠款期间至少启动4个。该网络旨在通过探索临床试验设计中的创新，通过患者利益相关者在试验计划中的更好和更早的参与以及在实施和执行试验方面的创造性改进来改变紧急研究企业。