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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10NS086484-02
Application #
8739336
Study Section
Special Emphasis Panel (ZNS1-SRB-G (68))
Program Officer
Vivalda, Joanna
Project Start
2013-09-30
Project End
2018-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
2
Fiscal Year
2014
Total Cost
$389,383
Indirect Cost
$134,488
Name
Ohio State University
Department
Neurology
Type
Schools of Medicine
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210