Despite recent advances, neurological diseases continue to be a major public health problem and are the source of significant morbidity and mortality not only in the United States, but world-wide. With the explosion of new knowledge in the neurosciences, the possibility of dramatic reductions in the overall neurological disease burden exists, but translation of new laboratory findings into new human treatments has lagged partially due to inefficiencies in the organization, funding, and execution of the necessary human clinical trials to prove the efficacy of new therapeutic approaches. The Network for Excellence in Neuroscience Clinical Trials (NEXT) is proposed to help expedite at least part of this process, specifically the conduct of early phase multi-center clinical trials to establish safety and dose information or to validate biomarkers and clinical outcomes in preparation for middle and late phase trials of efficacy. This application proposes the University of Virginia Health System as a Clinical Site for the NEXT network. The proposal describes the extraordinary experience and expertise of a multi-disciplinary cadre of clinical neurological investigators available to conduct NEXT clinical trials, an already existing clinical outreach program that will afford access to rura minority and medically underserved patient populations, an outreach program with statewide neurology practices that will maximize trial recruitment throughout the Commonwealth of Virginia, and the research infrastructure and leadership plan for successfully executing NEXT clinical trials at the University of Virginia.

Public Health Relevance

This proposal describes how investigators at the University of Virginia, in collaboration with others, will be organized to conduct important new research in patients to help find new treatments for people with diseases of the brain, spinal cord, muscle, and nerves. This research will have potentially major public health implications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10NS077260-03
Application #
8526586
Study Section
Special Emphasis Panel (ZNS1-SRB-G (51))
Program Officer
Moy, Claudia S
Project Start
2011-09-30
Project End
2018-06-30
Budget Start
2013-09-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$184,709
Indirect Cost
$101,723
Name
University of Virginia
Department
Neurology
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904