Yale Clinical Site: Investigations For Improved Neurological Treatments at Yale (INFINITY)

耶鲁临床中心：耶鲁改善神经治疗的调查（INFINITY）

• 批准号: 9981450
• 负责人: SERENA S SPUDICH
• 金额: $ 33.5万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981450
• 关键词: Academic Medical Centers; Adult; Advocacy; Agreement; Basic Science; Biological Markers; Caliber; Characteristics; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Communication; Communities; Community Hospitals; Conduct Clinical Trials; Connecticut; Development; Discipline; Disease; Enrollment; Ensure; Environment; Ethics; Faculty; Funding; Future; Geography; Goals; Hospitals; Immunobiology; Infrastructure; Institutional Review Boards; International; Intervention; Investigation; Knowledge; Laboratories; Lead; Leadership; Master' s Degree; Medicine; Mentors; Minority; Mission; Modeling; Multicenter Studies; Multicenter Trials; National Institute of Neurological Disorders and Stroke; Neurologic; Neurologist; Neurology; Neurosciences; Neurosurgeon; New England; Participant; Patient Recruitments; Patients; Positioning Attribute; Principal Investigator; Provider; Research; Research Personnel; Research Project Grants; Research Training; Resources; Rural; Science; Site; Structure; System; Talents; Training; Training Support; Translating; Translational Research; United States National Institutes of Health; Universities; Vision; Woman; Work; base; biomarker development; biomarker discovery; biomarker validation; biomedical referral center; clinical biomarkers; clinical center; clinical investigation; clinical research site; cohort; collaborative environment; data management; design; ethnic diversity; experience; follow-up; genome analysis; human subject protection; improved; innovation; investigator training; member; nervous system disorder; novel; operation; outreach; patient oriented research; patient population; programs; racial diversity; recruit; skills; socioeconomics; success; tertiary care; translational impact; translational scientist; translational study

We propose the designation of a Yale Neuroscience Clinical Trials Center (Yale INFINITY) as a Clinical Site in the NINDS Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT). INFINITY has been designed to serve as a vibrant and top-enrolling contributor to NeuroNEXT. Yale is the 7th largest hospital in the US, and Yale Neurology is 6th highest in NIH funding. Yale is widely recognized as a leading tertiary care center in neurology with a robust faculty and excellence in clinical research. Principal Investigator Dr. Kevin N. Sheth and Co-Principal Investigator Dr. Serena Spudich bring a complementary set of skills and experience in creating innovative clinical research programs in neurological disease. They have worked together at Yale for years, along with Dr. David Hafler, Neurology chair, and an enthusiastic cadre of faculty across disciplines, to create a highly collaborative environment focused on clinical research, multicenter trials, membership on Institutional Review Boards, clinical trial committees, and extensive mentoring in patient-oriented research. There is robust neurology representation in the Yale NIH-funded CTSA (Yale Center for Clinical Investigation – YCCI), and faculty have assumed positions of international leadership in their fields. Yale faculty have served as principal investigators in several multicenter studies and trials, including one of the NeuroNEXT trials, the NN103 BEAT MG Study, led by Dr. Richard Nowak, Trial Operations Co-Chair for Yale INFINITY. The Center already has existing infrastructure with an established track record of outreach, high quality patient enrollment, operational efficiency, research training, and communications. The Yale Clinical Site is strengthened by the following characteristics: 1) A pool of talented investigators with nationally recognized clinical research expertise across the entire spectrum of adult and pediatric neurological disorders, 2) a geographically diverse and large pool of patients in Connecticut and Southern New England currently not captured by the existing NeuroNEXT network, many of whom are seen at Yale specifically in order to participate in cutting edge trials, 3) talented teams of investigators with deep experience in clinical trials, recruitment and retention, and disease specific networks, 4) specific and nationally recognized expertise in biomarker development and validation, 5) a large cohort of ongoing NINDS-funded clinical studies to which the Yale Center can contribute to during any relative inactive period, 6) patient and community engagement embedded within the INFINITY leadership, 7) strong commitment from Yale institutional officials for participation in a central IRB and Master Trial Agreements, and 8) institutional commitments in the form of dedicated space and resources, as well as funding for a master's degree in clinical research for NeuroNEXT fellows. The Yale Neurological community is poised to make significant contributions to enhance and further the mission of NINDS and NeuroNEXT to reduce the burden of neurological disease.

我们建议指定耶鲁大学神经科学临床试验中心 (Yale INFINITY) 作为 NINDS 神经科学临床试验卓越网络 (NeuroNEXT) 的临床中心。 INFINITY 旨在成为 NeuroNEXT 充满活力的顶级贡献者。耶鲁大学是美国第七大医院，耶鲁神经病学在 NIH 资助中排名第六。耶鲁大学被广泛认为是神经病学领域领先的三级护理中心，拥有强大的师资力量和卓越的临床研究。首席研究员 Kevin N. Sheth 博士和联合首席研究员 Serena Spudich 博士在创建神经系统疾病创新临床研究项目方面带来了一套互补的技能和经验。他们与神经病学系主任 David Hafler 博士和一群热情的跨学科教职人员在耶鲁大学合作多年，创建了一个高度协作的环境，专注于临床研究、多中心试验、机构审查委员会成员资格、临床试验委员会以及以患者为导向的研究的广泛指导。耶鲁大学 NIH 资助的 CTSA（耶鲁临床研究中心 - YCCI）拥有强大的神经病学代表，并且教师在各自领域担任国际领导职务。耶鲁大学教师曾担任多项多中心研究和试验的主要研究者，其中包括 NeuroNEXT 试验之一，即由耶鲁大学 INFINITY 试验运营联席主席 Richard Nowak 博士领导的 NN103 BEAT MG 研究。该中心已经拥有现有的基础设施，在外展、高质量患者登记、运营效率、研究培训和沟通方面都有良好的记录。耶鲁大学临床基地具有以下特点：1) 一批才华横溢的研究人员，他们在成人和儿童神经系统疾病的整个范围内拥有全国公认的临床研究专业知识，2) 康涅狄格州和新英格兰南部目前尚未被现有 NeuroNEXT 网络捕获的地理多样化的大量患者，其中许多人专门在耶鲁大学就诊，以便参与前沿试验，3) 才华横溢的团队 在临床试验、招募和保留以及疾病特定网络方面拥有丰富经验的研究人员，4）生物标志物开发和验证方面的具体且全国公认的专业知识，5）一大批正在进行的 NINDS 资助的临床研究，耶鲁中心可以在任何相对不活跃的时期为这些研究做出贡献，6）INFINITY 领导层中嵌入的患者和社区参与，7）耶鲁机构官员对参与中央研究的坚定承诺 IRB 和主试验协议，以及 8) 以专用空间和资源形式做出的机构承诺，以及为 NeuroNEXT 研究员的临床研究硕士学位提供资金。耶鲁大学神经病学界准备为加强和推进 NINDS 和 NeuroNEXT 的使命做出重大贡献，以减轻神经系统疾病的负担。