Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) DCC

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PROJECT SUMMARY/ABSTRACT The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for neurological disorders. There are over 1000 different neurological disorders, many of which are associated with significant cognitive and physical disabilities. In the United States, neurological diseases affect over 100 million people of all ages, and they are a significant cause of mortality and disability. While therapeutic options are currently limited or non-existent for many of these disorders, recent exciting advances in the neurosciences and in gene therapies for neurological disorders make it imperative to increase the ability to efficiently perform clinical trials. A central goal of NeuroNEXT is to facilitate, from initial conception through final analysis, high-quality early phase clinical trials and biomarker studies with clear go/no-go decisions in adult and pediatric neurological disorders. This application requests funds for the University of Iowa to continue serving as the DCC for NeuroNEXT. The DCC will continue to support study design, data collection, data management, data sharing, project management, clinical site monitoring, quality management, safety monitoring, and all statistical aspects of trials conducted within the network. The DCC will continue to build on our robust, standardized, and accessible infrastructure in a manner that is explicitly designed to accommodate dynamically changing requirements that naturally occur in clinical trials, and will continue to help NeuroNEXT succeed in providing more rapid evaluations of promising treatments in the neurosciences. Specific Aim 1 is to work closely with the CCC to continue to support a collaborative network community that efficiently solicits and conducts high-quality clinical trials for neurological disorders. Specific Aim 2 is to continue to provide high-quality IT/development, data management, statistical, and protocol coordination support for all network clinical trials. Specific Aim 3 is to expand the pool of experienced clinical Investigators, research staff, and biostatisticians who are prepared to be leaders of multicenter clinical research trials.