Harvard Partners Neurology NEXT Clinical Trial Site

描述(由申请者提供)：我们建议建立一个哈佛合作伙伴临床网站，旨在成为NINDS神经科学临床试验卓越网络(NEXT)的顶级参与者和具有科学活力的贡献者。哈佛合作伙伴网站将由马萨诸塞州总医院(MGH)和布里格姆妇女医院(BWH)组成，这两家公认的三级护理中心拥有庞大的教职员工和对神经系统疾病临床研究的高度热情。首席研究员Steven M.Greenberg，MD，PhD(MGH)和共同首席研究员Anthony A.Amato，MD(BWH)带来了一系列互补的技能和经验，包括创建创新和协作的临床研究计划，积极参与多中心试验，在以患者为导向的神经学研究中提供广泛的指导，在机构审查和数据和安全监测委员会的成员，以及各自领域的国内和国际领先职位。哈佛合作伙伴网站将得到研究护士协调员Darlene Sawicki的进一步支持，Darlene Sawicki是一名经验丰富的多中心临床试验协调员和经理，以及一支由MGH和BWH联合调查员组成的团队，他们在成人和儿童神经疾病领域拥有全国公认的临床研究专业知识。哈佛合作伙伴网站的优势包括：1)在共享的合作伙伴机构审查委员会(IRB)、人类研究事务办公室和先进的信息技术基础设施的推动下，MGH和BWH研究人员之间密切的个人和机构联系；2)涵盖各种常见和不常见的神经系统疾病的大量临床人群，许多患者特别因为有机会参与尖端研究而被激励在合作伙伴网站上看到他们；3)具有经过证明的记录的候选人现场调查人员团队，他们在有效招募和保留受试者、成功参与针对疾病的试验网络以及对研究启动和设计的关键科学贡献方面做出了关键的科学贡献；4)由NlNDS资助的大量正在进行的临床研究，哈佛合作伙伴团队可以在下一次试验中任何相对不活跃的时间段对其做出贡献；5)哈佛合作伙伴现场调查人员将可获得的大量现有临床研究计划，如神经学临床试验单位、哈佛催化临床和转化科学奖(CTSA)计划和转化医学单位；6)获得一系列专门的临床研究资源，包括Martinos生物医学成像中心、全国第一个远程中风中心、植入性神经技术的大脑门计划、布罗德研究所和哈佛神经发现中心；以及7)哈佛合作伙伴机构官员对中央IRB模式的完全认可，并在下一步研究中使用主试验协议。哈佛合作伙伴完全赞同建立一个高效的临床研究中心联盟的下一个愿景，并提供资源、专业知识和热情承诺，以加强网络未来的成功。

DESCRIPTION (provided by applicant): 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.