Thursday, November 21, 2024
11/21/2024
Project Summary / Abstract Abstract 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 National Institute of Neurological Disorders and Stroke (NINDS) has identified a need for a network of stroke clinical trial centers in order to prioritize and efficiently design and conduct exploratory (Phase II) clinical trials and confirmatory (Phase III) clinical trials to identify and advance stroke treatments. The NIH Stroke Net is a multidisciplinary stroke research infrastructure that includes a National Clinical Coordinating Center, a National Data Management Center (NDMC), 24 Regional Coordinating Centers, and the NINDS. Its mission is to develop and test new therapies for stroke treatment, recovery, and prevention that can decrease the global burden of stroke. 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 end, the Data Coordination Unit (DCU) at the Medical University of South Carolina has developed a web-based comprehensive integrated electronic data capture and clinical trials management system, WebDCU™, that enables data entry from the participating clinical sites with extensive data quality control and that provides the necessary tools to efficiently manage operational activities for concurrent multiple trials, while ensuring compliance with the NINDS Common Data Elements and FDA guidance and regulations. 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, biomarker and neuroimaging data. In addition, the WebDCU™ incorporates a trial management information system that provides full support for all study operational activities in the Stroke Net. In collaboration with the study Principal Investigator and other parties of the Stroke Net, the NDMC biostatisticians: 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; disseminate study results via presentations and publications; and create public use data sets for data sharing when a study is completed.
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