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

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）的临床研究中心。INFINITY旨在成为NeuroNEXT充满活力和顶级注册的贡献者。耶鲁大学是美国第七大医院，耶鲁大学神经病学在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和共同首席研究员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。他们已经在耶鲁大学一起工作了多年，沿着与大卫哈夫勒博士，神经病学主席，和一个热情的跨学科教师干部，创造一个高度合作的环境，专注于临床研究，多中心试验，在机构审查委员会，临床试验委员会的成员，并在以患者为导向的研究广泛的指导。在耶鲁大学NIH资助的CTSA（耶鲁大学临床研究中心- YCCI）中有强大的神经病学代表，教师们在各自领域担任国际领导职务。耶鲁大学的教师曾担任多项多中心研究和试验的主要研究者，包括NeuroNEXT试验之一，NN 103 BEAT MG研究，由耶鲁大学INFINITY试验运营联合主席Richard Nowak博士领导。该中心已经拥有现有的基础设施，具有既定的外展记录，高质量的患者招募，运营效率，研究培训和通信。耶鲁大学临床研究中心通过以下特点得到加强：1）一批才华横溢的研究人员，在整个成人和儿科神经系统疾病领域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地区地理位置多样化且数量庞大的患者群，目前尚未被现有的NeuroNEXT网络捕获，他们中的许多人专门在耶鲁大学参加尖端试验，3）在临床试验，招募和保留以及疾病特异性网络方面具有丰富经验的才华横溢的研究人员团队，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）正在进行的NINDS资助的临床研究的大型队列，耶鲁中心可以在任何相对不活跃的时期做出贡献，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IRB和主试验协议的坚定承诺，以及8）以专用空间和资源形式的机构承诺，以及为NeuroNEXT研究员提供临床研究硕士学位的资金。耶鲁大学神经学社区准备作出重大贡献，以加强和进一步的NINDS和NeuroNEXT的使命，以减少神经疾病的负担。

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.