Harvard Partners Neurology NEXT Clinical Trial Site

哈佛合作伙伴神经病学 NEXT 临床试验网站

基本信息

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
项目类别：
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

项目摘要

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密切合作的马萨诸塞州总医院和布莱根妇女医院组成。哈佛合作伙伴网站在其最初的资助期间一直是该网络成功的主要贡献者。哈佛合作伙伴对 NeuroNEXT 的主要贡献包括 1) 在一系列神经学试验中成功、高效地招募了参与者，实现了 NeuroNEXT 的研究受试者注册总数排名第七，中央 IRB 平均批准到首次同意间隔排名第四，2)全面领导哈佛合作伙伴研究人员资助的两项 NeuroNEXT 试验以及发起其他三项 NeuroNEXT 试验提案，3) 领导该网络针对行业的管道开发委员会外展；4) 启动 NeuroNEXT 试验数据的两项辅助分析。目前的建议是让哈佛合作伙伴保持在 NeuroNEXT 网站的前沿，在过去的成功基础上增加新的举措和方法。博士。 Steven M. Greenberg（马萨诸塞州总医院神经科副主席兼 NeuroNEXT 管道开发委员会联合主席）和 Anthony A. Amato（布莱根妇女医院神经科副主席兼 GNE 肌病 NeuroNEXT109 试验的总体 PI）将留任作为站点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) 管道开发委员会针对神经系统疾病基金会的新外展工作，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 临床研究奖学金由联合研究员 James D. Berry 博士领导，并得到两个合作伙伴部门的资金承诺的补充，该奖学金将包括如何执行和领导多站点临床试验的实践培训和关于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、其首席研究员所表现出的领导力和积极的承诺、以及其杰出的忠诚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，确保了未来成功的可能性很高，并持续为卓越网络做出重大贡献。