Harvard Partners Neurology NEXT Clinical Trial Site

描述（由申请人提供）：我们提出了一个哈佛合作伙伴的临床网站，旨在作为一个顶级的招生和科学充满活力的贡献者的NINDS网络卓越的神经科学临床试验（NEXT）。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，这两个广泛认可的三级保健中心拥有大量的师资力量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）和联合首席研究员Anthony A.阿马托，医学博士（BWH）带来了一套互补的技能和经验，创造创新和合作的临床研究计划，积极参与多中心试验，在以患者为导向的神经学研究，对机构审查和数据和安全监测委员会的成员，以及在各自领域的国家和国际领导地位的广泛指导。哈佛合作伙伴研究中心将得到研究护士协调员Darlene Sawicki的进一步支持，Darlene Sawicki是一位经验丰富的多中心临床试验协调员和经理，MGH和BWH合作研究者团队在成人和儿童神经系统疾病领域具有国家认可的临床研究专业知识。本提案中利用的哈佛合作伙伴研究中心的优势包括1）MGH和BWH研究者之间的密切个人和机构联系，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提供便利; 2）大量的临床人群，涵盖了所有常见和不常见的神经系统疾病，许多患者特别是有机会参与尖端研究，因此有动力在Partners就诊; 3）有才能的候选研究中心研究者团队，具有有效招募和保留受试者的良好记录，成功参与疾病特异性试验网络，以及对研究启动和设计的关键科学贡献; 4）大量正在进行的NIDS资助的临床研究，哈佛合作伙伴团队可以在NEXT试验中的任何相对不活跃的间隔期间对其做出贡献; 5）将提供给哈佛合作伙伴研究中心研究者的众多现有临床研究项目，如神经病学临床试验单位、哈佛催化剂临床和转化科学奖（CTSA）项目和转化医学单位; 6）获得一系列专业的临床研究资源，包括Martinos生物医学成像中心、美国第一个Telestroke中心、植入式神经技术的Brain Gate项目、Broad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心IRB模型的完全认可，并将主试验协议用于NEXT研究。哈佛合作伙伴完全赞同NEXT的愿景，即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，以增强该网络未来的成功。

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.