NINDS Network for Excellence in Neuroscience: Clinical Research Site at UC Davis

该提案通过更新位于加利福尼亚州萨克拉门托的加州大学戴维斯健康系统的临床研究站点，为NINDS神经科学卓越网络（NeuroNEXT）做出贡献，萨克拉门托是美国人口最多的州的首府，也是美国最多样化和综合的城市之一。加州大学戴维斯分校NeuroNEXT临床研究站点将继续通过减轻神经系统疾病的负担来为NINDS的使命做出贡献。并提供基础设施，以扩大NINDS测试有希望的新疗法的能力，提高临床试验的效率，并在出现新的机会时迅速作出反应，以测试有希望的神经系统疾病患者治疗方法。我们作为现有的NeuroNEXT站点的经验，加州大学戴维斯分校卓越的神经科学研究-加州大学系统中最全面的校园，强大的转化研究基础设施，位于全国公认的，经验丰富的，具有竞争力的更新NIH CTSA（加州大学戴维斯分校CTSC），卓越的神经科学研究和研究培训，来自加州大学药物发现联盟的创新合作药物开发管道，国家远程医疗卓越中心，战略定位于促进社区外展，创新的数字健康信息学，用于病例识别和电子外展，完善的R25为学术科学家提供强大的神经治疗发现和开发创新培训，新的机构承诺为NeuroNEXT研究员提供高达70%的研究培训时间，以及R25多样化的学员管道。一个具有竞争力的更新和强大的Alpha诊所基因和细胞治疗临床试验基础设施，将有助于一个新的基因治疗联盟和基因治疗试验，并获得在一个具有积极临床关系的高排名区域卫生系统中管理的各种神经系统疾病患者，所有这些协同工作将使加州大学戴维斯分校继续成为NeuroNEXT网络的杰出和创新的临床研究基地。加州大学戴维斯分校NeuroNEXT的目标是：1)利用现有的资源和专业知识，作为一个NeuroNEXT中心，有效地实施科学合理的、可能含有生物标志物的探索性多中心神经科学临床试验，评估有前景的疗法，并提高加州大学戴维斯分校NeuroNEXT进行的试验的效率和质量；2)提供本地和区域社区外展，以改善患者招募和保留，并将社区合作伙伴充分融入转化研究企业；3)有效利用、多样化和利用创新的数字卫生信息学资源进行试验；4)为不同的早期职业研究者提供协作和创新的临床研究培训和支持性环境，以发展额外的研究技能并成为独立的临床研究者；5)与NeuroNEXT基因治疗联盟和加州大学戴维斯分校阿尔法诊所合作，有效地进行基因治疗试验。迄今为止，我们在本地、区域和全国取得的成就为未来的成功奠定了良好的基础。

This proposal contributes to the NINDS Network for Excellence in Neuroscience (NeuroNEXT) by renewing a clinical research site at the University of California Davis Health System located in Sacramento, CA, the capital of the most populous state in the country and one of the most diverse and integrated cities in the U.S. The UC Davis NeuroNEXT clinical research site will continue to contribute to the mission of NINDS by reducing the burden of neurologic diseases, and contribute an infrastructure which expands the NINDS capability to test promising new therapies, increase the efficiency of clinical trials, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders. Our experience as an existing NeuroNEXT site, neuroscience research excellence at UC Davis - the most comprehensive campus in the University of California system, a robust translational research infrastructure housed in a nationally recognized, experienced, and competitively renewed NIH CTSA (the UC Davis CTSC), neuroscience research and research training excellence, an innovative collaborative drug development pipeline from University of California Drug Discovery Consortium, a national center of excellence in telehealth strategically positioned to promote community outreach, innovative digital health informatics for case identification and electronic outreach, a well-established R25 offering strong innovative training in Neurotherapeutics Discovery and Development for Academic Scientists, new institutional commitment to protect up to 70% time for research training for NeuroNEXT Fellows and a R25 pipeline of diverse trainees, a competitively renewed and robust Alpha Clinic gene and cell therapy clinical trial infrastructure which will contribute to a new Gene Therapy Consortium and gene therapy trials, and access to diverse patients with neurological disorders managed in a highly ranked regional health system with active clinical affiliations, all work synergistically to position UC Davis to continue to be an outstanding and innovative Clinical Research Site for the NeuroNEXT network. UC Davis NeuroNEXT aims to: 1) Leverage existing resources and expertise to serve as a NeuroNEXT hub for efficiently implementing scientifically sound, possibly biomarker-informed exploratory multicenter neuroscience clinical trials evaluating promising therapies, and increase the efficiency and quality of trials conducted at UC Davis NeuroNEXT; 2) Provide local and regional community outreach to improve patient recruitment and retention and fully integrate community partners into the translational research enterprise; 3) Efficiently utilize, diversify, and leverage innovative digital health informatics resources for trials; 4) Provide collaborative and innovative clinical research training and a supportive environment for diverse early-career investigators to develop additional research skills and become independent clinical investigators; and 5) Partner with the NeuroNEXT Gene Therapy Consortium and UC Davis Alpha Clinic to efficiently conduct gene therapy trials. Our accomplishments to date – locally, regionally, and nationally – provide an outstanding foundation for future success.