Heartland Unit for Neuroscience Trials

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DESCRIPTION (provided by applicant): The University of Kansas (KU) has a rich history and portfolio of neurological clinical and translational research, with over 150 active neuroscience-related clinical trials. Clinical and translational research in Kansas City has accelerated in recet years, and KU's Institute for Advancing Medical Innovations has become a national leader in drug development. KU will capitalize on this momentum and form the Heartland Unit for Neuroscience Trials (HUNT) to provide infrastructure, centralized resources, access to patients, and coordination of our region's neuroscience investigators, thereby increasing their responsiveness to NEXT trials and efficiency in conducting those trials. The HUNT will integrate with and draw on existing institutional resources to form two specific cores dedicated to efficiently meet study requirements: a Regulatory Core (RC) and an Outreach Core (OC). The RC will provide full-service regulatory and contractual support, while the OC will expand the pool of potential research participants and work with investigators to exceed recruitment goals. For the last two decades, KU's Research Institute has supported investigators with comprehensive regulatory and contractual support. More recently, KU developed a Research-Participant-Registration Program deployed across outpatient clinics and supported by a new Bioinformatics program. These existing resources position us well to develop the HUNT as an integrated and cohesive unit for supporting the region's specialist neuroscience investigators. Specifically, the HUNT aims to 1) increase the efficiency and quality of neurological-disease-specific clinical trials by providing a coordinated regional team of specialist investigators with an RC for comprehensive regulatory support and an OC for expanding the pool of potential study participants; 2) extend the reach of neurological-disease-specific clinical trials by training new investigators across the region and the state of Kansas; and 3) enhance the NEXT consortium with unique capabilities for translational drug development.