Harvard Partners Neurology NEXT Clinical Trial Site

哈佛合作伙伴神经病学 NEXT 临床试验网站

• 批准号: 10223444
• 负责人: Steven M Greenberg
• 金额: $ 33.92万
• 依托单位: MASSACHUSETTS GENERAL 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/10223444
• 关键词: Adult; Agreement; Berry; Clinical Investigator; Clinical Research; Clinical Trials; Consent; Course Content; Custom; Data; Data Analyses; Development; Enrollment; Environment; Fellowship; Fellowship Program; Foundations; Funding; Future; General Hospitals; Goals; Healthcare; Home; Hospitals; Industry; Infrastructure; Institutional Review Boards; International; Lead; Leadership; Massachusetts; Methodology; Multi-Institutional Clinical Trial; Multiple Sclerosis; Myasthenia Gravis; Myopathy; Neurologic; Neurology; Neurosciences; Patient Care; Patient Recruitments; Performance; Population; Principal Investigator; Procedures; Research Infrastructure; Research Personnel; Resources; Role; Schedule; Site; Stroke; Study Subject; Talents; Time; Training; Training Programs; Woman; base; clinical research site; clinical trial enrollment; improved; innovation; nervous system disorder; novel marker; novel therapeutics; outreach; patient oriented research; patient population; programs; responsible research conduct; success; training opportunity

The Harvard-Partners clinical research site in the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) is comprised of Massachusetts General Hospital and Brigham and Women's Hospital working in close partnership. The Harvard-Partners site has been a major contributor to the network's success throughout its initial funding period. Among Harvard- Partners' major contributions to NeuroNEXT have been 1) successful and efficient participant recruitment across a range of neurologic trials, achieving NeuroNEXT's 7th highest total of study subject enrollments and 4th fastest average central IRB approval-to-first consent interval, 2) overall leadership of two of NeuroNEXT's funded trials by Harvard-Partners investigators as well as initiation of three other NeuroNEXT trial proposals, 3) leadership of the network's Pipeline Development Committee aimed at industry outreach, and 4) initiation of two ancillary analyses of NeuroNEXT trial data. The current proposal is for Harvard-Partners to remain at the forefront of NeuroNEXT sites, building on past successes and adding new initiatives and approaches. Drs. Steven M. Greenberg (Vice Chair of Massachusetts General Hospital Neurology and Co- Chair of the NeuroNEXT Pipeline Development Committee) and Anthony A. Amato (Vice Chair of Brigham and Women's Hospital Neurology and overall PI for the NeuroNEXT109 trial for GNE Myopathy) will remain as site Principal Investigators and network leaders. New initiatives for the upcoming funding period will include 1) an innovative NeuroNEXT clinical research fellowship program, 2) a new outreach effort by the Pipeline Development Committee towards neurologic disease-oriented foundations, and 3) improved internal procedures for assuring data timeliness and accuracy. The Harvard-Partners NeuroNEXT Clinical Research Fellowship, to be led by Co-Investigator Dr. James D. Berry and supplemented by funding commitments from the two Partners departments, will encompass both hands-on training in how to perform and lead multisite clinical trials and custom-built course curricula in trial methodology and responsible conduct of research. Harvard-Partners' record of success, the demonstrated leadership and energetic commitment of its Principal Investigators, and its outstanding pool of committed and talented clinical investigators, available patient populations, and research infrastructure assure high likelihood of future success and continued major contributions to network excellence.

神经科学临床试验卓越网络（NeuroNEXT）中的哈佛合作伙伴临床研究站点由马萨诸塞州总医院和布里格姆妇女医院密切合作组成。在最初的融资阶段，哈佛合作伙伴网站一直是该网络成功的主要贡献者。在哈佛合作伙伴对NeuroNEXT的主要贡献中，1)成功有效地招募了一系列神经系统试验的参与者，实现了NeuroNEXT在研究受试者注册总数中排名第七，从中央IRB批准到首次同意的平均时间间隔排名第四；2)由哈佛合作伙伴研究人员全面领导了两项NeuroNEXT资助的试验，并启动了另外三项NeuroNEXT试验提案。3)领导该网络的管道开发委员会，旨在拓展行业；4)启动两项对NeuroNEXT试验数据的辅助分析。目前的提议是让哈佛合作伙伴继续走在NeuroNEXT网站的前沿，在过去成功的基础上，增加新的举措和方法。Drs。Steven M. Greenberg （Massachusetts General Hospital Neurology副主席兼NeuroNEXT管道开发委员会联合主席）和Anthony A. Amato （Brigham and Women's Hospital Neurology副主席兼NeuroNEXT109 GNE肌病试验总负责人）将继续担任项目的主要研究者和网络领导者。即将到来的资助期的新举措将包括1)创新的NeuroNEXT临床研究奖学金计划，2)管道开发委员会对神经疾病导向基金会的新推广努力，以及3)改进内部程序以确保数据的及时性和准确性。哈佛合作伙伴NeuroNEXT临床研究奖学金将由联合研究员James D. Berry博士领导，并由两个合作伙伴部门的资金承诺补充，将包括如何执行和领导多地点临床试验的实践培训，以及在试验方法和负责任的研究行为方面定制的课程课程。哈佛合作伙伴的成功记录，其主要研究人员的领导力和精力充沛的承诺，以及其杰出的有承诺和有才华的临床研究人员，可用的患者群体和研究基础设施确保了未来成功的高可能性，并继续为网络卓越做出重大贡献。