Network of Excellence in Neuroscience Clinical Trials (University of Pittsburgh CRS)

为了将神经治疗发展的快速进展转化为患者护理，临床试验必须跟上临床前发现的步伐。在神经科学临床试验中遇到的障碍包括监管机构批准的延迟、招募的缓慢、参与者失去随访以及将研究结果转化为临床实践的缓慢。匹兹堡大学拥有独特而重要的资源，在临床试验中表现优异，特别是在NeuroNEXT方面。匹兹堡大学（University of Pittsburgh）拟议的NINDS神经科学试验卓越网络（NEXT-UP）的目标是：(1)建立一个管理结构，以快速实施跨广泛神经系统疾病的NeuroNEXT试验；(2)促进学术医生、社区医生、患者和患者支持团体之间在NeuroNEXT试验中的合作和推广；(3)将早期研究者临床研究培训与NEXT-UP活动相结合，促进临床试验研究事业的发展。NEXT-UP领导力计划通过项目总监（Paula R. Clemens，医学博士）和联合项目总监（Lawrence R. Wechsler，医学博士）来反映这些目标；咨询委员会包括专业知识和联络成人和儿童神经内科医生和患者；早期调查者；和一个项目协调员。合作将通过定期会议和向提供者和社区外展来建立。招聘将通过大量转诊提供者和社区外展进行。效率和监测将通过使用中央审计委员会和标准化试验协议来实现；为每次试验制定时间表和基准；联合调查员每月向NEXT-UP领导层提交报告；以及针对遇到的挑战制定的纠正措施计划。促进临床试验研究的职业将包括早期临床神经科学研究人员的培训计划。匹兹堡大学医学中心在医疗保健领域的地区优势与这一创新提议的结合，将使NEXT-UP继续成为NeuroNEXT网络中的一个示范站点，有效地开展临床试验，将研究人员与社区提供者、患者和受训人员整合在一起。

To translate the rapid progress in neurological therapeutic developments to patient care, clinical trials must keep pace with preclinical discoveries. Hurdles encountered in neuroscience clinical trials include delays in regulatory approvals, slow recruitment, participants lost to follow-up and slow translation of findings to clinical practice. The University of Pittsburgh has unique and significant resources and a proven track record of excellent performance in clinical trials, and in NeuroNEXT in particular. The aims of the proposed NINDS Network of Excellence in Neuroscience Trials at the University of Pittsburgh (NEXT-UP) are: (1) to develop an administrative structure to rapidly implement NeuroNEXT trials across of wide range of neurological conditions; (2) to foster collaboration and outreach in NeuroNEXT trials among academic physicians, community physicians, patients and patient support groups; and (3) to promote careers in clinical trial research by integrating clinical research training of early-stage investigators with NEXT-UP activities. The NEXT-UP leadership plan reflects these goals with a Program Director (Paula R. Clemens, MD) and co-Program Director (Lawrence R. Wechsler, MD); an Advisory Committee incorporating expertise and liaison to adult and pediatric neurology clinicians and patients; an early stage investigator; and a Program Coordinator. Collaboration will be established by meeting regularly and outreach to providers and the community. Recruitment will occur through high-volume referral providers and community outreach. Efficiency and monitoring will be accomplished through use of a central IRB and standardized trial agreements; establishing a timeline and benchmarks for each trial; monthly reports to the NEXT-UP Leadership from co-Investigators; and Corrective Action plans for challenges encountered. Promotion of careers in clinical trial research will include a training plan for early stage clinical neuroscience investigators. The combination of the University of Pittsburgh Medical Center's regional dominance in healthcare and this innovative proposal will allow NEXT-UP to continue to be a model site in the NeuroNEXT network with efficiently run clinical trials integrating investigators with community providers, patients and trainees.