Harvard Partners Neurology NEXT Clinical Trial Site

描述（由申请人提供）：我们推荐一个哈佛合作伙伴临床站点，旨在为NINDS卓越神经科学临床试验网络（NEXT）提供顶级注册和科学活力的贡献者。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，这两家被广泛认可的三级护理中心拥有庞大的院系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医学博士（MGH）和联合首席研究员Anthony a . Amato医学博士（BWH）在创建创新和协作临床研究项目、积极参与多中心试验、广泛指导以患者为导向的神经学研究、机构审查和数据与安全监测委员会成员、以及在各自领域担任国家和国际领导职务方面具有互补的技能和经验。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，她是一位经验丰富的多中心临床试验协调员和经理，以及一个由MGH和BWH共同调查员组成的团队，他们在成人和儿童神经系统疾病方面具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)MGH和BWH研究人员之间密切的个人和机构联系，由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促进；2)广泛的临床人群，涵盖了所有常见和不常见的神经系统疾病，许多患者因为有机会参与前沿研究而被邀请到Partners就诊；3)有才华的候选现场调查员团队，在有效招募和保留受试者、成功参与特定疾病试验网络以及在研究启动和设计方面做出关键科学贡献方面具有良好的记录；4)大量正在进行的由nlnds资助的临床研究，哈佛合作伙伴团队可以在NEXT试验的任何相对不活跃的间隔期间做出贡献；5)众多现有的临床研究项目将提供给哈佛合作伙伴的现场调查人员，如神经病学临床试验单元、哈佛催化剂临床和转化科学奖（CTSA）项目和转化医学单元；6)获得一系列专门的临床研究资源，包括马蒂诺斯生物医学成像中心（美国第一个中风中心）、植入式神经技术脑门项目、布罗德研究所和哈佛神经发现中心；7)哈佛合作伙伴机构官员对中央IRB模型的全面认可，并在NEXT研究中使用主试验协议。哈佛合作伙伴完全分享NEXT的愿景，建立一个高效的临床研究中心联盟，并提供资源、专业知识和热情的承诺，以增强网络未来的成功。

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.