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，并且在临床试验中表现优异。匹兹堡大学拟议的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NEXT试验；(2)促进NEXT试验在社区医生、患者和患者支持团体之间的合作和推广；(3)将培训与NEXT-UP活动相结合，促进临床试验研究事业的发展。NEXT-UP领导力计划反映了这些目标，包括项目总监（Lawrence R. Wechsler，医学博士）和联合项目总监；一个咨询委员会，由成人神经科医生、儿科神经科医生、神经外科医生和具有特定试验专业知识的轮换成员组成；和一个项目协调员。合作将通过定期会议和反馈会议来建立。招聘将通过大量转诊提供者、积极监测和社区外展进行。外展活动包括NEXT-UP学院、注册中心、网站和学习伙伴计划。效率和监测将通过以下方式实现：一级联邦IRB模型；标准化试用协议；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生涯将包括一个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地区优势与这一创新提议的结合，将使NEXT- up成为NEXT网络中的一个示范站点，有效地将研究人员、社区提供者、患者和学员整合在一起进行临床试验。

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. PUBLIC HEALTH RELEVANCE: Potential treatments for neurological disorders are rapidly developing. However delays occur in translating this to care for patients due to the lack of efficiency of clinical trials. The proposed NINDS Network of Excellence in Neuroscience trials at the University of Pittsburgh will creatively leverage its extensive resources to rapidly implement clinical trials with academic investigators, community providers and patients.