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

神经科学临床试验卓越网络（匹兹堡大学 CRS）

• 批准号: 8729029
• 负责人: Paula R Clemens
• 金额: $ 30.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8729029
• 关键词: Academy; Address; Adult; Advisory Committees; Agreement; Benchmarking; Childhood; Clinic; Clinical; Clinical Data; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Communities; Community Outreach; Community Physician; Conduct Clinical Trials; Data Coordinating Center; Disease; Educational workshop; Enrollment; Evaluation; Feedback; Fellowship Program; Fostering; Frequencies; Goals; Hand; Healthcare; Institutes; Institution; Institutional Review Boards; Intervention; Leadership; Low Prevalence; Maryland; Medical center; Mission; Modeling; Monitor; National Institute of Neurological Disorders and Stroke; Neurologic; Neurologist; Neurosciences; Neurosurgeon; Ohio; Participant; Patient Care; Patients; Pennsylvania; Performance; Phase; Physicians; Process; Provider; Registries; Reporting; Research; Research Infrastructure; Research Personnel; Residencies; Resources; Running; Site; Structure; Support Groups; Time; TimeLine; Training; Translating; Translational Research; Translations; Universities; West Virginia; base; career; career development; clinical care; clinical practice; clinical research site; cost; design; experience; follow-up; innovation; meetings; member; nervous system disorder; outreach; outreach program; patient registry; pre-clinical; programs; therapeutic development; web site; working group

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.

描述（由申请人提供）：为了将神经系统治疗发展的快速进步转化为患者护理，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部门批准的延迟，缓慢的招聘，参与者失去了随访以及对临床实践的发现缓慢的转化。匹兹堡大学拥有独特而大量的资源，并在临床试验中具有出色表现的良好表现。匹兹堡大学（下一步）拟议的NINDS神经科学试验卓越卓越网络的目的是：（1）开发一种行政结构，以迅速实施各种神经系统状况的下一个试验； （2）在社区医师，患者和患者支持小组中进行下一次试验中促进合作和宣传； （3）通过将培训与接下来的活动相结合来促进临床试验研究的职业。下一个领导计划与计划主任（Lawrence R. Wechsler，MD）和联合计划主任反映了这些目标；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于试验专业知识的旋转成员的咨询委员会；和计划协调员。合作将通过定期见面和反馈会议来建立。招聘将通过大批量推荐提供者，积极的监视和社区外展活动进行。外展包括下一个学院，注册表，网站和学习合作伙伴计划。效率和监视将通过：联合IRB模型来实现：标准化审判协议；为每个试验建立时间表和基准；每月向共同投资者的下一个领导层报告；以及遇到挑战的纠正行动计划。 促进临床试验研究中的职业将包括一项涉及所有职业级别的培训计划，包括：下一个讲习班，下一个选修课以及与更高级的共同投资者实施下一次试验的手动体验。匹兹堡大学医学中心在医疗保健领域的区域优势和这项创新提案的结合将使接下来的建立成为下一个网络中的模型地点，并有效地运行了临床试验，将研究人员与社区提供者，患者和受训者整合在一起。