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

为了将神经学治疗发展的快速进展转化为患者护理，临床试验必须与临床前的发现保持同步。神经科学临床试验中遇到的障碍包括监管审批延迟、招募缓慢、参与者无法跟进以及将研究结果转化为临床实践缓慢。匹兹堡大学拥有独特而重要的资源，在临床试验中，特别是在NeuroNEXT方面，有着良好的业绩记录。匹兹堡大学拟议的NINDS神经科学试验卓越网络(NEXUP)的目标是：(1)继续并加强有效的管理结构，有能力在各种神经疾病中迅速实施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试验中的合作和拓展；以及(3)通过将对早期研究人员的临床研究培训与后续活动相结合，并将其与有效的指导相结合，促进临床试验研究的职业生涯。下一步的领导计划反映了这些目标，其中包括一名项目主任(马里兰州Paula R.Clemens)、一个纳入专业知识并与成人和儿科神经病学临床医生和患者联系的咨询委员会、一名早期调查员和一名项目协调员。将通过定期会晤以及与供应商和社区进行接触来建立协作。招聘将通过大量转介提供者和社区外联进行。将通过以下方式实现效率和监测：使用中央内部审查委员会和标准化的试验协议；为每项试验确定时间表和基准；联合调查员向下一级领导层提交的月度报告；以及针对遇到的挑战的纠正行动计划。促进临床试验研究的职业发展将包括对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主导地位、匹兹堡大学临床与转化科学研究所(CTSI)的资源以及这一创新提议的结合，将使Next-Up继续成为NeuroNEXT网络中的样板站点，高效地运行临床试验，将研究人员与社区提供者、患者和受训者整合在一起。

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 continue and enhance an effective administrative structure with the capacity to rapidly implement NeuroNEXT trials across the 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 and pair them with effective mentoring. The NEXT-UP leadership plan reflects these goals with a Program Director (Paula R. Clemens, MD); an Advisory Board 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, resources from the Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh 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.