UCI-NEXT, a NeuroNEXT site

UCI-NEXT将UCI在神经科学、干细胞生物学和设备开发方面的卓越研究成果与人类临床试验所有阶段、人类研究保护、试验设计创新以及招募和保留新战略方面的主要研究团队的丰富集体经验结合在一起。UCI致力于卓越的临床转译研究，强大的现有临床试验基础设施，大学内从事临床和转译研究的各个研究部门之间的无缝整合，再加上奥兰治县独特的(种族和种族)多元化人口(49%是西班牙裔，20%是亚裔)，这使UCI处于一个独特而有希望的位置，可以非常成功地实施一个网络，进行科学合理、生物标志物信息丰富、高效、探索性的神经科学临床试验，这不仅将推进NINDS的使命，在普通人群中推进神经疾病的治疗，而且将独特地服务于橙县和邻近县传统上代表较少的大量少数族裔人口。UCI在招募良好的临床试验方面有着良好的记录，并在此类临床试验中非常成功地招募了不同种族的少数群体。UCI-NEXT的具体目标是1)通过NeuroNEXT基础设施每年招募和保留多个试验的受试者，为期7年，2)促进高度多样化参与者的登记，3)确保所有NeuroNEXT试验的及时启动，包括人类受试者批准和合同谈判，4)确定和招募优秀的临床医生和科学家作为NeuroNEXT试验的现场PI，5)将NeuroNEXT试验的启动时间表与UCI的其他神经科学试验进行比较，6)增强下一个财团在加州大学欧文分校内及其各种研究单位在转译药物发现和设备开发方面的独特能力，7)继续创新招募和保留战略，以增强网络全面和快速招募下一项试验的能力；以及8)通过在奥兰治和邻近县培训新一代神经科学医生试验者，扩大神经疾病特定临床试验的覆盖范围。

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.