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Network for Excellence in Neuroscience Clinical Trials NeuroNEXT

Marissa Natelson Love, MD1; Hassah Fathallah-Shaykh, MD, PhD1,2,3,4,5,6
[+] Author Affiliations
1Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama
2Department of Mathematics, University of Alabama at Birmingham, Birmingham, Alabama
3Department of Cell Biology, University of Alabama at Birmingham, Birmingham, Alabama
4Department of Mechanical and Biomedical Engineering, University of Alabama at Birmingham, Birmingham, Alabama
5UAB Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama
6UAB Comprehensive Neuroscience Center, University of Alabama at Birmingham, Birmingham, Alabama
JAMA Neurol. 2013;70(10):1227-1228. doi:10.1001/jamaneurol.2013.3663.
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The US National Institute of Neurological Disorders and Stroke (NINDS) recently launched the first trial that will take advantage of the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT).13 Through this initiative, the National Institutes of Health and NINDS hope to accelerate the progress of biomarker validation studies and therapeutic interventions through the phase 2 trial stage into clinical practice. NeuroNEXT consists of a Clinical Coordinating Center at Massachusetts General Hospital (request for application [RFA] NS-11-009), a Data Coordinating Center at University of Iowa (RFA NS-11-010), and 25 clinical sites throughout the United States (RFA NS-11-008). Academic and industry investigators studying neurologic diseases in children and adults can use this program by applying for grant funding while at the same time gaining access to the resources of NeuroNEXT. Small businesses may apply using the U44 Small Business Innovation in Clinical Trials (PAR-11-345) opportunity. Other institutions not associated with an institute of higher education may apply using the Infrastructure Resource Access (X01) (PAR-11-344). They will be using an agreement similar to that used by the National Cancer Institute to protect intellectual property of industry participants while testing their therapies. Foundations and advocacy groups also play an important role in study development through their partnership with NeuroNEXT. The NINDS has plans to dedicate $84 million over the next 7 years to alleviate the bottleneck of drugs in development for neurologic disorders.3 This will decrease the burdens of cost and time, especially with the application of a central institutional review board to eliminate the need for institutional review board approval at each investigational site.

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