Stroke Trials Network National Data Management Center (NDMC)

描述(申请人提供)：中风是一种致残性疾病，通常是致命的，影响所有年龄段的人，但主要是老年人。随着美国人口老龄化，中风发病率预计将上升；因此，它对公共卫生和卫生资源利用的影响将继续显著。卒中进展审查小组和NINDS已经确定了对卒中临床试验中心网络的需求，以便优先并有效地设计和进行翻译和探索性早期I/II期临床试验和大型III期临床试验 识别和推进中风治疗的试验。NINDS卒中试验网络是一个多学科卒中研究基础设施，由一个国家临床协调中心、一个国家数据管理中心(NDMC)和25个地区协调中心组成。NDMC的作用是与网络中的所有参与方建立合作关系，并提供高效和标准化的中央数据管理，在中风试验的规划和执行中产生高质量的数据和统计支持。为此，南卡罗来纳医科大学的数据协调股(DCU)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，还提供必要的工具来有效管理多个试验的操作活动，同时确保符合NINDS通用数据元素和FDA法规。使用WebDCU系统，我们将开发、实施和维护一个中央数据库，以简化和最大限度地提高临床、生物标记物和神经成像数据的数据收集、处理和监测的管理效率。此外，WebDCU“将纳入试验管理信息系统，为卒中试验网络中的所有研究业务活动提供全面支持。NDMC的神经成像核心将为中风试验创建神经成像存储库。与研究首席调查员和卒中试验网络的其他各方合作，DCU生物统计学教员将：为创新和高效的方案开发(包括研究设计和病例报告表格开发)做出贡献；统计监测研究进展；为dsmb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。最后，作为神经急症治疗试验(NETT)网络的统计和数据管理中心，DCU提供了NETT和卒中试验网络之间无缝协作的独特优势。

DESCRIPTION (provided by applicant): Stroke is a disabling and often fatal disease that affects all ages, but mostly in the elderly. Stroke incidence is expected to rise in the US as its population ages; therefore, its impact on public health and health resources utilization will continue to be significant. The Stroke Progress Review Group and NINDS have identified a need for a network of stroke clinical trials centers in order to prioritize and efficiently design nd conduct translational and exploratory early Phase I/II clinical trials and large Phase III clinical trials to identify and advance stroke treatments. The NINDS Stroke Trials Network is a multidisciplinary stroke research infrastructure that consists of a National Clinical Coordinating Center, a National Data Management Center (NDMC), and 25 Regional Coordinating Centers. The NDMC'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 and statistical support in the planning and execution of the stroke trials. To this en, 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 and also provides the necessary tools to efficiently manage operational activities for multiple trials, while ensuring compliance with the NINDS Common Data Elements and FDA regulations. Using the WebDCU¿ system, we will develop, implement and maintain a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical, biomarker and neuroimaging data. In addition, the WebDCU" will incorporate trial management information system that will provide full support for all study operational activities in the Stroke Trials Network. The Neuroimaging Core of the NDMC will create neuroimaging repository for the stroke trials. In collaboration with the study Principal Investigator and the other parties of the Stroke Trials Network, the DCU biostatistics faculty members will: contribute to the innovative and efficient protocol development (including study design and case report forms development); statistically monitor study progress; generate reports for the DSMB 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. Finally, as the Statistics and Data Management Center for the Neurological Emergencies Treatment Trials (NETT) Network, the DCU offers unique advantage of seamless collaboration between the NETT and Stroke Trials Networks.