The traditional model of conducting stroke clinical trials is characterized by redundancy and duplication of infrastructure and effort, inefficient and often incomplete recruitment, and difficulty in combining data across trials. The Comprehensive Stroke and Neurovascular Center at the Ohio State University (OSU) and Nationwide Children Hospital (NCH) are submitting this application for consideration to participate as a Regional Coordinating Stroke Center (RCC) to achieve the following specific aims;1. Develop a solid, cost-effective infrastructure that can quickly and efficiently implements both pediatric and adult stroke clinical trials encompassing the full breadth of cerebrovascular disease;2. Identify quickly, recruit aggressively, enroll efficiently and maintain and retain effectively the necessary study participants for each clinical study;3. Coordinate the participation of multiple spokes in te network and ensure the safety and rights of all participants in the trials;and minimize participant burden through efficient scheduling and completion of all study procedures and clinical center visits;4. Collaborate with network members in developing compelling clinical research applications and testing innovative telemedicine approaches to enhance informed trial consent process and patients follow-up;5. Use the NINDS stroke network initiatives and programs as a major component in training junior faculty, and research coordinators in the appropriate design and conduct of stroke clinical trials. 6. Coordinate with other RCC hubs in the network to integrate data and use Stroke Common Data Element (CDE) to facilitate comparison of results across studies and facilitate meta-analysis research.

Public Health Relevance

The traditional model of conducting stroke clinical trials is characterized by redundancy and duplication of infrastructure and effort. The Stroke Progress Review Group identified the pressing need for an efficient and responsive stroke clinical trial network to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment, and recovery.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZNS1-SRB-G (68))
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Vivalda, Joanna
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Ohio State University
Schools of Medicine
United States
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