University of Miami NeuroNEXT Trial Site

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The development of new therapeutics for patients with neurological disorders, which critically hinges on the efficiency of clinical trials, may be greatly facilitated by clinical trials consortia. The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) aims to conduct multiple; scientifically sound, possibly biomarker informed, exploratory clinical trials of the most promising therapies. This proposal outlines the University of Miami's application to serve as a clinical trial site in the NeuroNEXT consortium, in partnership with Nemours Children's Hospital for pediatric studies. The experience and expertise of the investigative team at the University of Miami (UM) and Nemours, the commitment, infrastructure and investment of the Department of Neurology and the School of Medicine in clinical and translational research, and the ethnic and racial diversity (66% Hispanic, 19% Black) of the south Florida community, uniquely position us to contribute to the mission of NINDS to reduce the burden of neurological disease that is borne by every segment of society. In addition to serving as an efficient and productive member of the NeuroNEXT consortium, we have the capacity and expertise to make a significant contribution to the enrollment of Hispanics and Blacks in NeuroNEXT trials, a demographic that has historically been underrepresented in NINDS sponsored trials. The specific goals of our NeuroNEXT team are to continue service as an effective site in the NeuroNEXT network, leveraging our unique strengths and expertise for the benefit of the broader network; and to continue development our clinical-translational workforce, providing young investigators and research staff with educational, training and career growth opportunities. Specific components of the research strategy focus on the efficiency of the process of clinical research implementation, the use of a culturally sensitive approaches to recruitment of the Hispanic population, education and training of new clinical investigators, recognition of the pivotal role that research coordinators play in the clinical trials process and a commitment to provide expertise and assistance to investigators engaged in other NINDS sponsored trials.