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

描述(由申请人提供)：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和重要的资源，以及在临床试验中出色表现的可靠记录。建议的匹兹堡大学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，以快速实施涵盖各种神经疾病的NEXT试验；(2)促进社区医生、患者和患者支持团体在NEXT试验中的合作和推广；以及(3)通过将培训与后续活动相结合，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，包括一名计划主任(马里兰州劳伦斯·R·韦克斯勒)和联合计划主任；一个咨询委员会，由一名成人神经科医生、儿科神经科医生、神经外科医生和具有试验专门知识的轮值成员组成；以及一名计划协调员。将通过定期会议和反馈会议来建立协作。招聘将通过大量转介提供者、积极监测和社区外联进行。外展范围包括下一步的学院、注册、网站和学习伙伴计划。将通过以下方式实现效率和监测：第一级联合IRB模式；标准化试验协议；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一项涉及所有职业水平的培训计划，包括：下一阶段研讨会、下一阶段选修课，以及与更资深的合作研究员一起实施下一项试验的实践经验。匹兹堡大学医疗中心在医疗保健领域的地区主导地位与这一创新提议的结合，将使NEXT-UP成为下一个网络中的样板站点，该网络将高效地运行临床试验，将研究人员与社区提供者、患者和受训人员整合在一起。

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.