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

我们建议指定耶鲁神经科学临床试验中心（Yale INFINITY）作为NINDS卓越神经科学临床试验网络（NeuroNEXT）的临床站点。INFINITY旨在为NeuroNEXT提供一个充满活力和最热门的贡献者。耶鲁大学是美国第七大医院，耶鲁神经病学是美国国立卫生研究院资助的第六大医院。耶鲁大学被广泛认为是神经病学领域领先的三级医疗中心，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博士在创建神经疾病创新临床研究项目方面具有互补的技能和经验。他们与耶鲁大学神经学主席大卫·哈夫勒（David Hafler）博士以及一群热情的跨学科教师一起合作多年，创造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、临床试验委员会成员，以及以患者为导向的研究的广泛指导。在耶鲁国立卫生研究院资助的CTSA（耶鲁临床研究中心- YCCI）中有强大的神经病学代表，教师在他们的领域中担任国际领导地位。耶鲁大学的教职员工在多个多中心研究和试验中担任主要研究人员，其中包括由耶鲁INFINITY试验运营联合主席理查德·诺瓦克博士领导的NeuroNEXT试验之一NN103 BEAT MG研究。该中心已经拥有现有的基础设施，具有良好的外展记录，高质量的患者登记，运营效率，研究培训和沟通。耶鲁大学临床中心有以下特点：1)一群在成人和儿童神经系统疾病的整个范围内具有全国公认的临床研究专业知识的有才华的研究人员；2)康涅狄格州和新英格兰南部地区地域多样化的大量患者，目前尚未被现有的NeuroNEXT网络所覆盖，其中许多人专门在耶鲁大学接受治疗，以参与尖端试验；3)在临床试验方面具有丰富经验的有才华的研究团队；招募和保留，以及疾病特定网络，4)在生物标志物开发和验证方面的特定和国家认可的专业知识，5)在任何相对不活跃的时期，耶鲁中心都可以为ninds资助的大量正在进行的临床研究做出贡献，6)INFINITY领导层内部的患者和社区参与，7)耶鲁机构官员对参与中央IRB和主试验协议的坚定承诺，8)机构承诺提供专门的空间和资源，以及资助NeuroNEXT研究员获得临床研究硕士学位。耶鲁大学神经学界准备为加强和深化NINDS和NeuroNEXT减轻神经系统疾病负担的使命做出重大贡献。

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.