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

NINDS 神经科学卓越网络：加州大学戴维斯分校的临床研究中心

• 批准号: 10745254
• 负责人: Craig M. McDonald
• 金额: $ 44万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-06 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10745254
• 关键词: Address; Adult; Affect; Biological Markers; California; Capital; Cell Therapy; Characteristics; Childhood; Cities; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Communities; Community Outreach; Country; Data; Development; Disease; Disease Management; Electronics; Environment; Faculty; Foundations; Functional disorder; Funding; Future; Gene therapy trial; Goals; Health system; Industry; Infrastructure; Institution; Link; Medicine; Mission; National Institute of Neurological Disorders and Stroke; Natural History; Neurology; Neurosciences; Neurosciences Research; Outcome; Patient Recruitments; Patients; Personal Satisfaction; Persons; Phase II Clinical Trials; Population; Population Scientist Supplement (R25); Positioning Attribute; Preparation; Protocols documentation; Public Health; Public Health Informatics; Quality of life; Regenerative Medicine; Research; Research Infrastructure; Research Personnel; Research Training; Resource Informatics; Resources; Scientist; Site; Standardization; System; Testing; Therapy Clinical Trials; Time; Training; Translational Research; United States National Institutes of Health; Universities; Vision; Work; biomarker validation; burden of illness; career; clinical outcome measures; clinical research site; design; digital health; drug development; drug discovery; experience; functional improvement; gene therapy; gene therapy clinical trial; improved; innovation; nervous system disorder; new therapeutic target; novel therapeutics; outreach; patient retention; programs; recruit; response; skills; sound; success; supportive environment; telehealth; translational research program

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.

这一建议有助于NINDS网络卓越的神经科学（NeuroNEXT）通过更新位于加利福尼亚州萨克拉门托的加州戴维斯卫生系统大学的临床研究站点，加州大学戴维斯分校NeuroNEXT临床研究中心将通过减轻NINDS的负担，继续为NINDS的使命做出贡献NINDS的目标是为神经系统疾病的治疗提供一个基础设施，扩大NINDS测试有前途的新疗法的能力，提高临床试验的效率，并在新的机会出现时迅速做出反应，为神经系统疾病患者测试有前途的治疗方法。我们作为一个现有的NeuroNEXT网站的经验，在加州大学戴维斯分校的神经科学研究卓越-在加州系统的大学，一个强大的转化研究基础设施，在一个国家认可的，经验丰富的，有竞争力的更新NIH CTSA最全面的校园（加州大学戴维斯分校CTSC），神经科学研究和研究培训卓越，来自加州大学药物发现联盟的创新合作药物开发管道，该联盟是远程医疗战略定位的国家卓越中心，旨在促进社区外展，用于病例识别和电子外展的创新数字健康信息学，一个完善的R25，为学术科学家提供强大的神经治疗学发现和开发创新培训，新的机构承诺保护高达70%的时间用于NeuroNEXT研究员的研究培训，以及R25不同学员的管道，一个具有竞争力的更新和强大的阿尔法诊所基因和细胞治疗临床试验基础设施，这将有助于新的基因治疗联盟和基因治疗试验，并获得不同的神经系统疾病患者在一个高排名的区域卫生系统管理，具有积极的临床联系，所有的工作协同定位加州大学戴维斯分校继续成为一个杰出的和创新的临床研究网站的神经网络。UC Davis NeuroNEXT旨在：1）利用现有的资源和专业知识，作为NeuroNEXT中心，有效地实施科学合理的，可能生物标志物知情的探索性多中心神经科学临床试验，评估有前途的疗法，并提高在UC Davis NeuroNEXT进行的试验的效率和质量;（二）提供当地和区域社区外展服务，以改善患者招募和保留，并将社区合作伙伴充分纳入翻译研究型企业; 3）有效地利用，多样化，并利用创新的数字健康信息学资源进行试验; 4）为不同的早期职业研究人员提供协作和创新的临床研究培训和支持环境，以发展额外的研究技能并成为独立的临床研究者;和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。我们迄今为止在地方、区域和全国取得的成就为未来的成功奠定了坚实的基础。