Harvard Partners Neurology NEXT Clinical Trial Site

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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.