Boston Children's Hospital and Beth Israel Deaconess Medical Center NeuroNEXT Clinical Research Site

NeuroNEXT正在通过集中数据处理和机构审查委员会的批准，同时鼓励和发展强大而稳定的多中心基础设施，加快神经疾病临床试验的实施。NeuroNEXT成功的关键是机构的参与，这些机构拥有专职的临床医生和研究人员，他们是各种神经病学亚专业的专家，为各种疾病的大量患者提供服务。在这项相互竞争的延续申请中，波士顿儿童医院(BCH)与邻近的贝丝以色列女执事医疗中心(BIDMC)联手成立了一个单一的临床研究网站，可以参与各种疾病的成人和儿童的临床试验，这些疾病包括肌肉营养不良、多发性硬化症和亨廷顿病。这个新的双机构临床研究网站建立在现有的成功关系的基础上，在过去的20年里，两个组织共享了神经学住院医师和奖学金计划，以及过去7年的R25培训资助计划。此外，这两个机构都有密切的持续工作关系，两家医院的一些研究人员都获得了证书。我们这项建议的具体目标是：(1)推进BCH/BIDMC NeuroNEXT网站作为共享基础设施平台，随时准备参与各种神经病学临床试验；(2)为NeuroNEXT和其他由NINDS资助的试验识别和招募符合条件的患者；(3)为网络审查生成创新的试验申请，目标是在未来的NeuroNEXT研究中被命名为牵头CRS；(4)与NeuroNEXT数据协调中心有效合作，同时展示在出版和传播研究结果方面的专长；(5)遵守标准化的网络政策，同时也标准化机构、部门、部门和个人的合作协议；以及(6)培训新的临床研究人员，使其掌握独立临床研究生涯所需的技能，同时最大限度地利用当地的临床研究教育和支持服务。总而言之，BCH/BIDMC临床研究网站将成为外部研究人员未来研究的有效和热情参与者，同时也将成为创新想法的来源，这些创新想法将有助于推动临床神经科学向前发展，并确定针对整个疾病谱的神经疾病的新的、有效的疗法。

NeuroNEXT is accelerating the implementation of clinical trials in neurological disease by centralizing data processing and institutional review board approval while also encouraging and developing a strong and stable multi-center infrastructure. Critical to the success of NeuroNEXT is the participation of institutions with dedicated clinician-researchers expert in a wide variety of neurological subspecialties serving a wealth of patients with a diverse array of conditions. In this competing continuation application, Boston Children's Hospital (BCH) joins forces with neighboring Beth Israel Deaconess Medical Center (BIDMC) to form a single clinical research site that can participate in clinical trials in adults and children across the disease spectrum, with conditions ranging from muscular dystrophy to multiple sclerosis to Huntington's disease. This new dual- institution clinical research site builds off an existing successful relationship in which both organizations have shared neurology residency and fellowship programs for the past 20 years as well as an R25 training grant program for the past seven years. Moreover, both institutions have had a close ongoing working relationship with a number researchers being credentialed at both hospitals. Our specific aims of this proposal are: (1) to advance the BCH/BIDMC NeuroNEXT site as a shared infrastructure platform poised for the ready participation in a variety of neurology clinical trials; (2) to identify and recruit eligible patients for NeuroNEXT and other NINDS-funded trials; (3) to generate innovative trial applications for Network review, with the goal of being named lead CRS in a future NeuroNEXT study; (4) to collaborate effectively with the NeuroNEXT Data Coordinating Center, while demonstrating expertise in publication and dissemination of research results; (5) to abide by standardized Network policies, while also standardizing institutional, divisional, departmental, and individual collaborative agreements; and (6) to train new clinical investigators in skills required for an independent career in clinical research while maximizing site co-investigator use of local clinical research educational and support services. In summary, the BCH/BIDMC clinical research site will serve as an effective and enthusiastic participant in future studies generated by outside investigators while will also being a source for innovative ideas that will help propel clinical neuroscience forward and the identification of new, effective therapies for neurological disorders across the disease spectrum.