Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites)

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CinciNEXT is a unique collaboration between the free-standing Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati (UC) that aims to continue to be a productive clinical site in the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) network. The objective of the proposed application is to secure the infrastructural support needed to maintain the outstanding quality of clinical trials that the CinciNEXT site has conducted for the NEXT Network during the first and second cycles of support. Specific goals of CinciNEXT are to facilitate the implementation, enhance recruitment, maximize retention, and optimize study conduct of NeuroNEXT network studies. A second goal is to actively contribute to the overall success of the NeuroNEXT network by participating in network governance, network committees, and network activities. The third goal is to implement a new/junior investigator career advancement program to help them develop skills and experience to participate and/or lead future NeuroNEXT and other NINDS trials. These goals will be achieved by the combination of our experienced CinciNEXT leadership team (two co-PIs and one fulltime research study coordinator with over 9 years of NeuroNEXT experience working together), enthusiastic research collaborators, existing outstanding research infrastructure (including a CTSA), robust breadth and depth of patients available to participate in trials, and two supportive research administrations. Both institutions have shown their commitment to the NeuroNEXT Network by agreeing to continue to use a standardized Master Trial Agreement and employ a Tier 1 level of centralized IRB review. The CinciNEXT clinical site anticipates continuing to provide outstanding recruitment, retention, and quality for NeuroNEXT network trials, and thereby advancing treatments for neurological disorders. CinciNEXT proposes to be a key partner in this NINDS network that has provided a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations.