Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

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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 adults and children with neurological disorders through partnerships with government, academia, private foundations and industry. Recent discoveries in basic neuroscience have directly led to major breakthroughs in the understanding of disease processes in neurological disorders, many which impose an enormous burden on individuals, families and communities. Yet there are several organizational and logistical challenges to testing these new therapies in multicenter clinical trials, including inefficiencies in regulatory and institutional approvals, barriers to recruitment and retention of study participants and a dearth of individuals trained and prepared to be the leaders of multicenter clinical research 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 by providing efficient methodological, organizational, statistical and logistical support. NeuroNEXT is comprised of 25 clinical sites, a Clinical Coordinating Center and a Data Coordinating Center. NeuroNEXT innovations include establishing a trial network that requires the use of a central institutional review board, a master contract process for all network- funded studies, centralized safety review of all studies by a single Data Safety Monitoring Board, broad sharing of Standard Operating Procedures and knowledge, state-of-the-art early development trial design approaches, and the use of the NINDS common data elements for data collection. Applicants who seek to use the network can be novice or experienced trialists, thereby greatly expanding the pool of experienced clinical investigators trained and prepared to lead multicenter trials. Nine studies involving partnerships with industry, foundations, academia and the government were funded in the first six years of the network. Specific Aim 1 is to work closely with the Data Coordinating Center to continue to support an open, collaborative network community that efficiently conducts high-quality clinical trials for neurological disorders. Specific Aim 2 is to greatly expand the pool of experienced clinical Investigators and research staff who are prepared to be leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Specific Aim 3 is to continue to provide high-quality project management and regulatory coordination for all Network clinical trials.