Vanderbilt University is ideally positioned to be a clinical site in the Network of Excellence in Neuroscience Clinical Trials (NEXT). The Principal Investigator and her co-investigators have participated in a multitude of diverse disease-oriented networks and multicenter trials, and have a strong track record of developing and participating in innovative trials with NIH (including NINDS), industry, and foundation support. The Vanderbilt NINDS Clinical Trials team will leverage the many strengths of the collegial, multidisciplinary environment for clinical and translational research on our campus, including the Vanderbilt Institute for Clinical and Translational Research, 38 funded Cores and Centers, and rich collaborations among the departments of Neurology, Pediatrics, Neurosurgery, Psychiatry, and Internal Medicine. Our overarching goal is to establish a Vanderbilt neuroscience clinical trials network site that is uniquely positioned to translate neuroscience advances into clinical practice through the conduct of exploratory clinical trials.
Our Specific Aims are: (1) To fully engage our collaborative leadership team in developing a transformative neuroscience network site that is agile and responsive to the needs of the overall NINDS Clinical Trials Network;(2) To leverage the abundant institutional resources of the Vanderbilt research enterprise-this will provide the NINDS Clinical Trials Network with deliverables including high enrollment and retention of study participants, with an emphasis on quality data and data integrity;and (3) To establish a cadre of new investigators focused on the developing and implementing neurological clinical trials. We are uniquely poised to provide mentorship and collaboration at all levels of education, including students, residents, fellows, junior faculty, and research staff. Vanderbilt is also committed to utilization of a central Institutional Review Board (IRB) model to aid in the efficiency of IRB reviews and to sharing of successful clinical trial practices with the other NINDS Clinical Trials Network sites.

Public Health Relevance

Unprecedented opportunities exist for the treatment of a broad spectrum of neurological disorders. These are being driven by rapidly accelerating advances in neuroscience. To meet these opportunities, a coordinated network of clinical sites is needed. This network will minimize redundancy and optimize recruitment in order to rapidly implement innovative trials in response to disease-specific opportunities.

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)
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Cordell, Janice
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Vanderbilt University Medical Center
Schools of Medicine
United States
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Carter, Melissa D; Calcutt, M Wade; Malow, Beth A et al. (2012) Quantitation of melatonin and n-acetylserotonin in human plasma by nanoflow LC-MS/MS and electrospray LC-MS/MS. J Mass Spectrom 47:277-85
Malow, Beth; Adkins, Karen W; McGrew, Susan G et al. (2012) Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. J Autism Dev Disord 42:1729-37; author reply 1738