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

描述（由申请人提供）：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。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）开发一个管理结构，以快速实施广泛的神经系统疾病的NEXT试验;（2）促进社区医生，患者和患者支持团体之间的NEXT试验的合作和推广;以及（3）通过将培训与NEXT-UP活动相结合，促进临床试验研究的职业发展。NEXT-UP领导力计划反映了这些目标，并有一位项目总监（Lawrence R. Wechsler，MD）和联合项目总监;由成人神经学家、儿科神经学家、神经外科医生和具有试验特定专业知识的轮换成员组成的咨询委员会;以及项目协调员。将通过定期会议和反馈会议建立合作关系。招募将通过大量转诊提供者、积极监测和社区外联进行。外联包括NEXT-UP学院，注册，网站和研究合作伙伴计划。将通过以下方式实现效率和监测：一级联合IRB模型;标准化试验协议;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涉及所有职业水平的培训计划，包括：NEXT-UP研讨会，NEXT-UP选修课，以及与更高级的合作研究者一起实施NEXT试验的实践经验。匹兹堡大学医学中心在医疗保健领域的区域主导地位和这一创新提案的结合将使NEXT-UP成为NEXT网络中的一个模范网站，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。

DESCRIPTION (provided by applicant): 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. 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 NEXT trials across of wide range of neurological conditions; (2) to foster collaboration and outreach in NEXT trials among community physicians, patients and patient support groups; and (3) to promote careers in clinical trial research by integrating training with NEXT-UP activities. The NEXT-UP leadership plan reflects these goals with a Program Director (Lawrence R. Wechsler, MD) and co-Program Director; an Advisory Committee with an adult neurologist, pediatric neurologist, neurosurgeon and rotating member with trial-specific expertise; and a Program Coordinator. Collaboration will be established by meeting regularly and feedback sessions. Recruitment will occur through high-volume referral providers, active surveillance and community outreach. Outreach includes the NEXT-UP Academy, registry, website and Study Partner Program. Efficiency and monitoring will be accomplished through: a tier-1 federated IRB model; 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 involving all career levels including: NEXT-UP workshops, a NEXT-UP elective, and hands on-experience implementing a NEXT trial with a more senior co-investigator. The combination of the University of Pittsburgh Medical Center's regional dominance in healthcare and this innovative proposal will allow NEXT-UP to become a model site in the NEXT network with efficiently run clinical trials integrating investigators with community providers, patients and trainees.