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 be a clinical site in the NlNDS-funded Network for Excellence in Neuroscience Clinical Trials (NEXT) network. The objective of the proposed application is to obtain infrastructural support to facilitate the implementation and optimize the quality of clinica trials conducted at the CinciNEXT site for the NEXT Network. Specific goals of CinciNEXT are to streamline startup, enhance recruitment, maximize retention and optimize study conduct of NEXT Network studies. Another goal is to actively contribute to the overall success of the NEXT network by participating in network governance, working groups (e.g. focused on planning and implementation of protocols), and network activities. The third goal is to implement ongoing training of new/junior clinical investigators/study coordinators to help them develop skills and experience to participate and/or lead future NEXT and other NINDS trials. These goals will be achieved by the combination of our experienced CinciNEXT leadership team (two co-Pls and two full-time research study coordinators), 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 NEXT Network by agreeing to use a standardized Master Trial Agreement, employ a Tier 1 level of centralized IRB review, and provide additional institutional funds to support two full-time CinciNEXT study coordinators (one pediatric-focused and one adult-focused). The CinciNEXT clinical site anticipates providing outstanding recruitment, retention and quality for NEXT Network trials, and thereby advancing treatments for neurological disorders. CinciNEXT proposes to be a key partner in this NINDS network that will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations.
Clinical trials determine whether a neuroscience discovery can improve the health of people with neurological disorders. They are frequently hampered by regulatory or budgetary issues, difficulties with patient recruitment, and other inefficiencies. Th proposed CinciNEXT clinical site will partner with the NEXT network to improve clinical-trial efficiency to bring more treatments to people with neurological diseases.
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