Stroke is the second leading cause of death in the world with an even greater burden of major disability. It occurs at all ages with the greatest incidence in the elderly. The number of stroke is expected to rise in the US and the world as the population ages. Its estimated direct and indirect cost in the U.S. for 2013 is $109.6 billion. In 2013, the National Institute of Neurological Disorders and Stroke (NINDS) formed a network of stroke clinical trials centers to prioritize and efficiently design and conduct exploratory (Phase II) and confirmatory (Phase III) clinical stroke trials as well as to provide a mechanism for training of the next generation of clinical stroke researchers. The NIH StrokeNet is a multidisciplinary stroke research infrastructure that includes a National Clinical Coordinating Center, a National Data Management Center (NDMC), 25 Regional Coordinating Centers and their associated regional hospitals, 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 NCC's roles are to establish and foster a collaborative relationship with all parties involved in the Network, to provide scientific and operational leadership in the development and execution of the stroke trials, and to oversee the educational development of StrokeNet fellows within StrokeNet. From a scientific standpoint, we have established three stroke working groups (acute, prevention and recovery/rehabilitation) that are led by senior clinical investigator leaders from the NCC with appropriate expertise. These working groups help PIs of clinical trial proposals with the scientific design and feasibility of a given trial. An imaging core, and four advisory committees (minority recruitment and retention, endovascular, pediatrics and ethics), centered within the NCC, also provide input to clinical trial development and execution. Operationally, the NCC houses the Central IRB (CIRB) for ongoing StrokeNet Trials that involves reliance agreements between the University of Cincinnati and over 300 local institutions, one of the largest IRB reliance networks in the U.S. The NCC is responsible for master trial agreements for all RCCs and the 381 participating hospital sites, all financial payments to participating sites regarding trial tasks, and the overall clinical study management of ongoing trials working with the respective PIs. Finally, the NCC houses the educational and mentoring core for the StrokeNet that provide education and training regarding stroke and stroke research to a broad base of diverse individuals within NIH StrokeNet (at least one fellow per RCC per year).

Public Health Relevance

Stroke is the second leading cause of death globally and a leading cause of neurological disability, and the prevalence, disability-burden, and costs are projected to rise substantially over the coming decades as a result of the aging populations worldwide. The NIH StrokeNet is a nationally organized stroke trial network designed to develop new treatments for acute stroke, for recovery and rehabilitation after stroke, and for prevention of stroke. The national coordinating center provides leadership and management of this network.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS086872-07
Application #
9753381
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Moy, Claudia S
Project Start
2013-09-30
Project End
2023-07-31
Budget Start
2019-08-01
Budget End
2020-07-31
Support Year
7
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Cincinnati
Department
Neurology
Type
Schools of Medicine
DUNS #
041064767
City
Cincinnati
State
OH
Country
United States
Zip Code
45221
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Broderick, Joseph P; Palesch, Yuko Y; Janis, L Scott et al. (2016) The National Institutes of Health StrokeNet: A User's Guide. Stroke 47:301-3
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