UCI-NEXT brings together UCI?s research excellence in neurosciences, stem cell biology and device development with the vast collective experiences of the lead investigative team in human clinical trials at all stages, human research protection, innovations in trial design, and novel strategies for recruitment and retention. The institutional commitments towards excellence in clinical translational research, the robust existing clinical trials infrastructure, and the seamless integration between the various research units within the University engaged in clinical and translational research combined with the uniquely (ethnically and racially) diverse population of Orange County (49% Hispanic and 20% Asian) places UCI in a unique and promising position to be highly successful in implementing a network for conducting scientifically sound, biomarker- informed, highly efficient, exploratory clinical trials in neurosciences that will not only advance the mission of NINDS to advance therapeutics in neurological disorders in general population, but also will uniquely serve the large minority populations in Orange and neighboring Counties, traditionally underrepresented in such trials. UCI has an excellent track record in recruiting well into clinical trials and have been very successful in recruiting ethnically diverse minority populations in such clinical trials. The specific goals of the UCI-NEXT aims are to 1) recruit and retain subjects for multiple trials a year for 7 years through the NeuroNEXT infrastructure, 2) facilitate enrollment of highly diverse participants, 3) ensure the timely start-up of all NeuroNEXT trials including human subject approval and contract negotiation, 4) Identify and recruit outstanding clinician- scientists to serve as site PI for NeuroNEXT trials, 5) compare the start-up timelines for NeuroNEXT trials to other neuroscience trials at UCI, 6) enhance the NEXT consortium with the unique capabilities for translational drug discovery and device development within UC Irvine and through its various research units, 7) continue to innovate in recruitment and retention strategies to enhance the network?s capacity to enroll fully and rapidly in the NEXT trials, and 8) extend the reach of neurological disease-specific clinical trials by training new generation of neuroscience physician trialists in Orange and neighboring counties.
The NEXT Network of 25 collaborating sites have demonstrated excellence in rapid, efficient, well-enrolled, biomarker-informed, phase 2 clinical trials in neurosciences and have paved the way for finding evidence- based treatments for patients with neurological diseases. UCI-NEXT plans to carry out this tradition and help and test new strategies to optimize individual trials. Inclusion and enrollment of minorities and underserved population, traditionally not included in clinical trials, will be the overarching goal of the UCI-NEXT.
