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，临床试验必须与临床前发现保持同步。神经科学临床试验中遇到的障碍包括监管批准的延迟，招募缓慢，参与者失访以及将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，以及在临床试验中表现出色的良好记录，特别是在NeuroNEXT。匹兹堡大学拟议的神经科学试验卓越NINDS网络（NEXT-UP）的目标是：（1）继续并加强有效的管理结构，使其能够在广泛的神经系统疾病中快速实施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的NeuroNEXT试验的合作和推广;以及（3）通过将早期研究者的临床研究培训与NEXT- UP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发展。NEXT-UP领导计划反映了这些目标，并有一个项目总监（Paula R。Clemens，MD）;一个咨询委员会，包括专业知识和联络成人和儿童神经科临床医生和患者;一个早期阶段的调查员;和一个计划协调员。将通过定期举行会议和与提供者和社区进行外联来建立协作。将通过大量转诊提供者和社区外联进行征聘。将通过使用中心IRB和标准化试验协议实现效率和监测;为每项试验建立时间轴和基准;合作研究者向NEXT-UP领导层提交月度报告;以及针对遇到的挑战制定纠正措施计划。促进临床试验研究的职业生涯将包括为早期临床神经科学研究者提供培训计划。匹兹堡大学医学中心在医疗保健领域的区域主导地位，匹兹堡大学临床和转化科学研究所（CTSI）的资源以及这一创新提案的结合将使NEXT-UP继续成为NeuroNEXT网络中的一个模型站点，有效地运行临床试验，将研究者与社区提供者，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.