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: 10593615
• 负责人: James Dale Berry
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593615
• 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中心由马萨诸塞州总医院和布里格姆妇女医院密切合作组成。哈佛合作伙伴网站在网络的初期筹资期间一直是其成功的主要贡献者。在哈佛-合作伙伴对NeuroNEXT的主要贡献中，1）在一系列神经病学试验中成功有效地招募了参与者，实现了NeuroNEXT的第七高研究受试者入组总数和第四快的平均中心IRB批准至首次同意间隔，2）NeuroNEXT资助的两项试验由哈佛全面领导-合作伙伴研究者以及其他三个NeuroNEXT试验提案的启动，3）网络的管道发展委员会的领导，旨在行业推广，和4）启动两个NeuroNEXT试验数据的辅助分析。目前的建议是哈佛合作伙伴保持在NeuroNEXT网站的最前沿，在过去的成功基础上，增加新的举措和方法。Steven M.博士Greenberg（马萨诸塞州总医院神经病学副主席和NeuroNEXT管道开发委员会联合主席）和Anthony A. Amato（布里格姆妇女医院神经病学副主席和GNE肌病NeuroNEXT 109试验的总体PI）将继续担任研究中心主要研究者和网络负责人。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）管道发展委员会对神经疾病导向基金会的新推广工作，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，将由共同研究者詹姆斯博士领导。Berry和来自两个合作伙伴部门的资金承诺的补充，将包括如何执行和领导多中心临床试验的实践培训，以及试验方法和负责任的研究行为的定制课程。哈佛合作伙伴的成功记录，其主要研究者的领导力和积极的承诺，以及其杰出的临床研究者，可用的患者群体和研究基础设施，确保了未来成功的可能性很高，并继续为网络卓越做出重大贡献。