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

神经科学临床试验卓越网络（匹兹堡大学 CRS）

基本信息

批准号：
10163275
负责人：
Paula R Clemens
金额：
$ 31.1万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10163275
关键词：
Adult Advisory Committees Agreement Benchmarking Childhood Clinical Clinical Data Clinical Investigator Clinical Research Clinical Sciences Clinical Trials Clinical Trials Network Collaborations Communities Community Outreach Community Physician Data Coordinating Center Enrollment Fostering Goals Healthcare Infrastructure Institutes Institution Institutional Review Boards Intervention Leadership Maryland Medical center Mission Modeling Monitor National Institute of Neurological Disorders and Stroke Neurologic Neurosciences Ohio Participant Patient Care Patients Pediatric Neurology Pennsylvania Performance Physicians Program Development Provider Reporting Research Research Personnel Research Training Resources Running Site Standardization Structure Support Groups TimeLine Training Training Programs Translating Translational Research Translations Universities West Virginia Work base career career development clinical care clinical practice clinical research site community clinic experience follow-up innovation meetings member nervous system disorder outreach outreach program patient registry performance site pre-clinical programs recruit success therapeutic development working group

项目摘要

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 develop an administrative structure to rapidly implement NeuroNEXT trials across of 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. The NEXT-UP leadership plan reflects these goals with a Program Director (Paula R. Clemens, MD) and co-Program Director (Lawrence R. Wechsler, MD); an Advisory Committee 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 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.

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，尤其是在Neuronext中表现出色的良好表现记录。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，以在广泛的神经系统状况中快速实施神经网络试验；（2）在学术医师，社区医生，患者和患者支持小组中，在神经网络试验中培养和宣传；（3）通过将早期研究人员的临床研究培训与下一个活动相结合，以促进临床试验研究的职业。下一个领导计划与计划主任（Paula R. Clemens，MD）和联合计划主任（Lawrence R. Wechsler，MD）反映了这些目标；一个咨询委员会，将成人和儿科神经病学临床医生和患者的专业知识和联络员纳入了咨询委员会；早期的调查员；和计划协调员。合作将通过定期见面并与提供者和社区开展。招聘将通过大批推荐提供者和社区宣传进行。效率和监控将通过使用中央IRB和标准化试验协议来实现；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。在临床试验研究中促进职业将包括针对早期临床神经科学研究者的培训计划。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发展能够继续成为Neuronext网络中的模型网站，并有效地运行了将研究人员与社区提供者，患者和受训者整合在一起的临床试验。