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

我们建议将耶鲁大学神经科学临床试验中心(Yale Infinity)指定为NINDS卓越神经科学临床试验网络(NeuroNEXT)的临床站点。Infinity的设计初衷是成为NeuroNEXT充满活力和排名靠前的贡献者。耶鲁大学是美国第七大医院，耶鲁大学神经科在美国国立卫生研究院的资助中排名第六。耶鲁大学被广泛认为是神经学领域领先的三级护理中心，拥有强大的教师队伍和卓越的临床研究能力。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计划方面带来了一套互补的技能和经验。多年来，他们与神经学主席David Hafler博士以及各学科热情的教职员工一起在耶鲁大学共同工作，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、临床试验委员会以及以患者为中心的研究方面的广泛指导。耶鲁国立卫生研究院资助的CTSA(耶鲁临床调查中心-YCCI)有强大的神经学代表，教职员工在各自领域承担了国际领先地位。耶鲁大学教职员工曾在多个多中心研究和试验中担任首席研究员，其中包括NeuroNEXT试验之一的NN103 Beat MG研究，该研究由耶鲁无限的试验操作联席主席Richard Nowak博士领导。该中心已经拥有现有的基础设施，并在外展、高质量的患者登记、运营效率、研究培训和沟通方面建立了良好的记录。耶鲁临床网站因以下特点而得到加强：1)在成人和儿科神经疾病的整个范围内拥有国家公认的临床研究专业知识的有才华的研究人员库；2)康涅狄格州和新英格兰南部的地理多样化的大量患者池，目前没有被现有的NeuroNEXT网络捕获，其中许多人在耶鲁大学专门为了参与尖端试验而被看到；3)在临床试验、招募和保留以及疾病特定网络方面具有深厚经验的有才华的研究人员团队，4)在生物标记物开发和验证方面的特定和国家公认的专业知识，5)一大批NINDS资助的正在进行的临床研究，耶鲁中心可以在任何相对不活跃的时期为其做出贡献，6)无限领导层中嵌入的患者和社区参与，7)耶鲁大学机构官员对参与中央IRB和主试验协议的坚定承诺，8)以专用空间和资源的形式的机构承诺，以及为NeuroNEXT研究员的临床研究硕士学位提供资金。耶鲁大学神经学界已做好准备，为加强和推进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.