NeuroNEXT Clinical Research Site at the University of Michigan

神经科学临床试验卓越网络(NeuroNEXT)由NINDS赞助，旨在创建加速儿童和成人神经系统疾病临床试验的基础设施。该项目将在密歇根大学(UM)建立一个临床试验站点，作为NeuroNEXT财团的一部分。UM在包括临床试验在内的临床神经科学研究方面有着深厚的传统，并拥有丰富的机构资源来促进临床试验。这些措施包括集中化的临床试验支持办公室、强大的临床研究协调员队伍、对临床试验的坚定机构承诺、接触广泛和多样化的患者群体以及不同的有经验的临床研究人员群体。这些特点使密歇根大学有资格成为富有成效的NeuroNEXT网站。作为一家NeuroNEXT网站，我们的目标是在5年的时间里参与至少4项NeuroNEXT试验，为NINDS赞助的其他试验提供实质性支持，协调我们在密歇根大学的机构资源和共享的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，以培养下一代神经疾病临床试验人员。为了实现这些目标，我们将遵守主临床试验协议，并使用集中式IRB。UM NeuroNEXT网站将由两名经验丰富的首席调查人员领导，他们在NINDS支持的临床试验、基金会支持的临床试验和药物支持的临床试验中有记录，并将由一个运营委员会管理。运行委员会将负责运行UM NeuroNEXT计划所需的主要决策，包括审查从NINDS收到的批准的临床方案，从UM NeuroNEXT现场教职员工中选择合适的首席研究员来承担试验责任，提供临床和行政支持以快速有效地进行试验，以及定期跟踪并向NINDS报告试验情况。UM NeuroNEXT网站还将提供一项培训计划，包括导师计划、教学学习经验和临床试验参与，以帮助早期临床研究人员发展从事学术临床研究所需的技能。

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.