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与领先的研究团队在所有阶段的人类临床试验，人类研究保护，试验设计创新以及招募和保留的新策略方面的丰富集体经验结合在一起。该机构致力于卓越的临床转化研究，强大的现有临床试验基础设施，以及大学内从事临床和转化研究的各个研究单位之间的无缝整合，橙子县的（种族和人种）多样化人口（49%的西班牙裔和20%的亚洲人）将UCI置于一个独特和有希望的位置，在实施一个网络进行科学合理的，生物标志物知情的，高效的，神经科学的探索性临床试验，不仅将推进NINDS的使命，以推进一般人群中神经系统疾病的治疗，而且还将独特地服务于橙子和邻近县的大量少数民族人群，传统上在此类试验中代表性不足。UCI在临床试验招募方面有着良好的记录，并且在此类临床试验中招募种族多样的少数群体方面非常成功。UCI-NEXT的具体目标是：1）通过NeuroNEXT基础设施，每年招募和保留多项试验的受试者，持续7年; 2）促进高度多样化的受试者入组; 3）确保及时启动所有NeuroNEXT试验，包括人类受试者批准和合同谈判; 4）确定和招募杰出的临床医生-科学家担任NeuroNEXT试验的研究中心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）通过UC Irvine内部及其各个研究单位的转化药物发现和设备开发的独特能力增强NEXT联盟，7）继续创新招募和保留策略，以增强网络在NEXT试验中充分和快速招募的能力，和8）通过在橙子和邻近县培训新一代神经科学医生试验者来扩大神经系统疾病特异性临床试验的范围。

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.