NeuroNEXT Clinical Research Site at the University of Michigan

由NINDS赞助的神经科学临床试验卓越网络（NeuroNEXT）旨在创建基础设施，加速儿童和成人神经系统疾病的临床试验。该项目将在密歇根大学（UM）建立一个临床试验中心，作为NeuroNext联盟的一部分。UM在临床神经科学研究方面有着悠久的传统，包括临床试验，以及促进临床试验的优秀机构资源。其中包括一个集中的临床试验支持办公室，一个强大的临床研究协调员库，对临床试验的强有力的机构承诺，接触广泛和多样化的患者人群，以及一组多样化的有成就的临床研究者。这些属性使密歇根大学有资格成为富有成效的NeuroNEXT网站。 我们作为NeuroNEXT网站的目标是在5年的奖励过程中参与至少4个NeuroNEXT试验，为其他NINDS赞助的试验提供实质性支持，协调我们在UM的机构资源与共享的NeuroNEXT网络基础设施，以提高效率，并为临床研究培训提供支持和资源，以培养下一代神经系统疾病临床试验者。为了实现这些目标，我们将遵守临床试验主协议并使用集中IRB。UM NeuroNEXT研究中心将由两名经验丰富的主要研究者领导，他们在NINDS、基金会和药物支持的临床试验中有跟踪记录，并将由运营委员会管理。运营委员会将负责UM NeuroNEXT项目运营所需的重大决策，包括审查从NINDS收到的获批临床方案，在UM NeuroNEXT研究中心教职员工中选择适当的首席研究者承担试验责任，提供临床和管理支持以快速有效地开展试验，以及定期向NINDS跟踪和报告试验性能。包括导师计划，教学学习经验和临床试验参与的培训计划也将是UM NeuroNEXT网站的一部分，以帮助早期临床研究人员发展在学术临床研究中追求职业所需的技能。

The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT), sponsored by NINDS, is designed to create infrastructure accelerating clinical trials for neurologic diseases in children and adults. This project will establish a Clinical Trials Site at the University of Michigan (UM) as part of the NeuroNext consortium. UM has a strong tradition in clinical neurosciences research, including clinical trials, and outstanding institutional resources to facilitate clinical trials. These include a centralized Clinical Trials Support Office, a robust pool of clinical research coordinators, strong institutional commitment to clinical trials, access to broad and diverse patient populations, and a diverse group of accomplished clinical investigators. These attributes qualify the University of Michigan as a productive NeuroNEXT site. Our goals as a NeuroNEXT site are to participate in a minimum of 4 NeuroNEXT trials over the course of the 5 year award, to provide substantial support for other NINDS sponsored trials, to coordinate our institutional resources at UM with the shared NeuroNEXT network infrastructure to increase efficiency, and to provide support and resources for clinical research training in order to develop the next generation of neurologic disease clinical trialists. To accomplish these goals, we will abide by a master clinical trial agreement and use a centralized IRB. The UM NeuroNEXT site will be led by two experienced Principal Investigators with track records in NINDS-, foundation- and pharmaceutical-supported clinical trials and will be administered by an Operating Committee. The Operating Committee will be responsible for the major decisions required in operating the UM NeuroNEXT program, including reviewing the approved clinical protocols received from NINDS, selecting the appropriate lead investigator among the UM NeuroNEXT site faculty to assume responsibility for the trial, providing the clinical and administrative support to conduct the trial rapidly and efficiently, as well as tracking and reporting trial performance to NINDS on a regular basis. A Training Program consisting of a mentorship program, a didactic learning experience, and clinical trial participation will also be part of the UM NeuroNEXT site to assist early stage clinical investigators in developing the skills needed to pursue careers in academic clinical research.