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 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 NeuroNEXT Network during the first cycle of support. Specific goals of CinciNEXT include to streamline startup, 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 and network committees. The third goal is to implement ongoing training of new/junior clinical investigators 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 two fulltime 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 NeuroNEXT by agreeing to continue to use a standardized Master Trial Agreement, employ central 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 continuing to provide outstanding recruitment, retention and data quality for NeuroNEXT trials, and thereby advance treatments for neurological disorders. The CinciNEXT site is an ideal location to continue to conduct NINDS clinical trials as part of the NeuroNEXT network.
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. The proposed CinciNEXT clinical site will partner with the NeuroNEXT network to improve clinical trial efficiency to bring more treatments to people with neurological diseases.
