We propose a Harvard Partners clinical site, designed to serve as a top-enrolling and scientifically vibrant contributor to the NINDS Network of Excellence in Neuroscience Clinical Trials (NEXT). The Harvard Partners site will be constituted by Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH), two widely recognized tertiary-care centers with large faculties and high levels of enthusiasm for the clinical investigation of neurologic disease. Principal Investigator Steven M. Greenberg, MD, PhD (MGH) and Co-Principal Investigator Anthony A. Amato, MD (BWH) bring a complementary set of skills and experience in creating innovative and collaborative clinical-research programs, active participation in multicenter trials, extensive mentoring in patient-oriented neurologic research, membership on Institutional Review and Data and Safety Monitoring Boards, and positions of national and international leadership in their fields. The Harvard Partners site will be further supported by Research Nurse Coordinator Darlene Sawicki, an experienced coordinator and manager of multicenter clinical trials, and a team of MGH and BWH Co-Investigators with nationally recognized clinical research expertise across the spectrum of adult and pediatric neurologic disorders. Strengths of the Harvard Partners site to be leveraged in this proposal include 1) the close personal and institutional ties between the MGH and BWH investigators, facilitated by a shared Partners Institutional Review Board (IRB), Office of Human Research Affairs, and advanced information technology infrastructure;2) large clinical populations spanning the full range of common and uncommon neurologic diseases, with many patients motivated to be seen at Partners specifically by the opportunity to participate in cutting-edge research;3) talented teams of candidate site investigators with proven track records for efficient subject recruitment and retention, successful participation in disease-specific trial networks, and key scientific contributions to study initiation and design;4) a larg body of ongoing NlNDS-funded clinical studies to which the Harvard Partners team can contribute during any relatively inactive intervals in NEXT trials;5) numerous existing clinical research programs that will be available to Harvard Partners site investigators, such as the Neurology Clinical Trials Unit, the Harvard Catalyst Clinical and Translational Science Award (CTSA) program, and the Translational Medicine Unit;6) access to a range of specialized clinical study resources, including the Martinos Center for Biomedical Imaging, the nation's first Telestroke center, the Brain Gate program for implantable neurotechnologies, the Broad Institute, and the Harvard NeuroDiscovery Center;and 7) full endorsement by Harvard Partners institutional officials of the central IRB model and the use of Master Trial Agreements for NEXT studies . Harvard Partners fully shares the NEXT vision for a consortium of efficient clinical research centers and offers the resources, expertise, and enthusiastic commitment to enhance the network's future success.
The Harvard Partners site will be comprised of MGH and BWH, the two flagship hospitals of Partners HealthCare and homes to two vibrant neurology departments with internationally recognized patient care and patient-oriented research programs. The proposed Harvard Partners site fully shares the vision of creating a core of sites capable of efficiently performing key clinical trials for neurological diseases and has the resources, commitment, and record of excellence to help bring this vision to life.