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

波士顿儿童医院和贝斯以色列女执事医疗中心 NeuroNEXT 临床研究基地

• 批准号: 10163923
• 负责人: BASIL T DARRAS
• 金额: $ 34.98万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 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/10163923
• 关键词: Adult; Age; Agreement; Biological Markers; Boston; Child; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Credentialing; Data Collection; Data Coordinating Center; Databases; Disease; Enrollment; Fellowship Program; Fragile X Syndrome; Funding; Future; Glioblastoma; Goals; Grant; Hospitals; Huntington Disease; Individual; Industry; Information Dissemination; Informed Consent; Infrastructure; Institution; Institutional Review Boards; Israel; Lead; Leadership; Medical; Medical center; Mentors; Monitor; Multi-Institutional Clinical Trial; Multiple Sclerosis; Muscular Dystrophies; Names; National Institute of Neurological Disorders and Stroke; Neurologic; Neurology; Neurosciences; Online Systems; Participant; Pathway interactions; Patients; Pediatric Hospitals; Peer Review; Physicians; Policies; Positioning Attribute; Procedures; Process; Protocols documentation; Publications; Rare Diseases; Research; Research Personnel; Research Project Grants; Residencies; Resources; Role; Safety; Services; Site; Source; Spinal Muscular Atrophy; Standardization; Sum; Testing; Training; Treatment Efficacy; career; clinical research site; clinical trial implementation; computerized data processing; cost; data quality; effective therapy; experience; innovation; member; nervous system disorder; patient population; phase II trial; phase III trial; program dissemination; programs; recruit; research study; skill acquisition; skills; success; therapeutic evaluation

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.

NeuroNEXT正在通过集中数据处理和机构审查委员会批准来加速神经系统疾病临床试验的实施，同时鼓励和开发强大而稳定的多中心基础设施。NeuroNEXT成功的关键是机构的参与，这些机构拥有专门的临床医生-研究人员，他们是各种神经学亚专业的专家，为患有各种疾病的患者提供服务。在这一竞争性延续申请中，波士顿儿童医院（BCH）与邻近的贝斯以色列女执事医疗中心（BIDMC）联手组建了一个单一的临床研究中心，可以参与各种疾病的成人和儿童的临床试验，包括肌肉萎缩症、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了现有的成功关系，其中两个组织在过去20年中共享神经病学住院医师和奖学金计划，以及过去7年的R 25培训补助金计划。此外，两家机构与两家医院的一些研究人员保持着密切的持续工作关系。我们的具体目标是：（1）推进BCH/BIDMC NeuroNEXT网站作为一个共享的基础设施平台，准备参与各种神经病学临床试验;（2）识别和招募符合条件的患者用于NeuroNEXT和其他NINDS资助的试验;（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CRS领导者;（4）与NeuroNEXT数据协调中心进行有效合作，同时展示研究结果出版和传播方面的专业知识;（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;和（6）培训新的临床研究者在临床研究中独立工作所需的技能，同时最大限度地提高研究中心的合作，研究者使用当地临床研究教育和支持服务。总之，BCH/BIDMC临床研究中心将作为外部研究者产生的未来研究的有效和热情参与者，同时也将成为创新思想的来源，这将有助于推动临床神经科学向前发展，并确定新的，有效的治疗神经系统疾病的方法。