Harvard Partners Neurology NEXT Clinical Trial Site

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网站由马萨诸塞州总医院和布里格姆妇女医院密切合作组成。在最初的资助期内，哈佛合作伙伴网站一直是该网络成功的主要贡献者。哈佛伙伴对NeuroNEXT的主要贡献包括：1)在一系列神经学试验中成功而高效地招募参与者，实现了NeuroNEXT第七高的研究对象登记总数和第四快的中心IRB从批准到第一同意的平均间隔；2)哈佛伙伴研究人员全面领导了NeuroNEXT资助的两项试验，并启动了另外三项NeuroNEXT试验提案；3)领导了旨在行业拓展的网络管道开发委员会；以及4)启动了对NeuroNEXT试验数据的两项辅助分析。目前的提议是让哈佛合作伙伴继续站在NeuroNEXT网站的前沿，在过去成功的基础上再接再厉，增加新的倡议和方法。Steven M.Greenberg博士(马萨诸塞州总医院神经病学副主席和NeuroNEXT管道开发委员会联席主席)和Anthony A.Amato博士(布里格姆和妇女医院神经病学副主席和针对GNE肌病的NeuroNEXT109试验的总体PI)将继续担任现场首席研究员和网络领导者。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)管道开发委员会向面向神经疾病的基金会进行的新的外展努力，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调查员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站点临床试验的实践培训，以及试验方法和负责任的研究进行的定制课程。哈佛合作伙伴的成功记录、首席研究人员表现出的领导力和精力充沛的承诺，以及杰出的尽职尽责和才华横溢的临床研究人员、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和对网络卓越的持续重大贡献。

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.