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.

我们提出了耶鲁神经科学临床试验中心（耶鲁大学无限）的设计，作为NINDS神经科学临床试验卓越网络（NeurOnext）的临床部位。无穷大的设计是为神经元的充满活力和顶级入围的贡献者。耶鲁大学是美国第七大医院，耶鲁大学的神经病学在NIH资金中排名第六。耶鲁大学被广泛认为是神经病学领先的三级护理中心，具有强大的教师，并且在临床研究方面出色。首席研究员Kevin N. Sheth博士和联合主管研究员Serena Spudich博士为创建神经系统疾病创新的临床研究计划提供了一系列技能和经验。他们在耶鲁大学与神经病学主席戴维·哈夫勒（David Hafler）博士一起工作了多年，以及跨学科的热情教师干部，创造了一个高度协作的环境，专注于临床研究，多中心试验，机构审查委员会的成员资格，临床试验承诺，临床试验承诺，并在患者面向患者的研究中进行了广泛的心理。耶鲁大学NIH资助的CTSA（耶鲁大学临床调查中心 - YCCI）中有强大的神经病学代表，并且教职员工在其领域担任国际领导地位。耶鲁大学的教职员工曾在几项多中心研究和试验中担任首席研究人员，其中包括一项神经元素试验，即由理查德·诺瓦克（Richard Nowak）博士领导的NN103 BEAT MG研究，耶鲁无限限度的试验行动共同主席。该中心已经拥有现有的基础设施，并具有宣传，高质量的患者入学率，运营效率，研究培训和沟通的良好记录。 Yale临床网站通过以下特征得到加强：1）在整个成人和儿科神经系统疾病中，拥有全国认可的临床研究专业知识的才华横溢的研究人员，2）2）一个在康涅狄格州和南部新英格兰的地理位置各异的患者，目前尚未被现有神经网络捕获的新英格兰的地理位置各不相同，并在新英格兰捕获了许多人，这些人在现有神经网络中占有一致，许多人都在努力，这些人在YEREXT网络中占有一致，这些人在许多人中均在YEREXT网络中进行过特殊的经过竞争，这些人在YEREXT网络中均参与了Yale的特殊情况，Yale均在Yale中进行过依据。在临床试验，招聘和保留方面具有深厚经验的研究人员，以及特定于疾病的网络，4）特定且全国认可的生物标志物发展和验证方面的专业知识，5）YALE中心在任何相对范围内都可以在任何相对范围内的官员中为YALE中心促进YALE中心的持续临床研究，6）YALE中心在Infrative Inderted中为Infertion distiond of Artisted of Infertions，6）7）Y），7）7）7） IRB和大师审判协议，以及8）以专用空间和资源的形式做出的机构承诺，以及为Neuronext Fellows临床研究硕士学位的资助。耶鲁大学神经社区被毒死，为增强Ninds和Neuronext的使命做出了重大贡献，以减少神经系统疾病的燃烧。