University of Pennsylvania Center for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT)

宾夕法尼亚大学神经科学临床试验卓越网络中心 (NeuroNEXT)

• 批准号: 10458532
• 负责人: Brenda Banwell
• 金额: $ 29.49万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10458532
• 关键词: Adult; Agreement; Area; Biometry; Caring; Child; Cities; Clinical; Clinical Investigator; Clinical Nursing Research; Clinical Research; Clinical Trials; Cohort Studies; Collaborations; Data Coordinating Center; Development; Disease; Enrollment; Ensure; Faculty; Fellowship Program; Goals; Health system; Hospitals; Individual; Industry; Innovative Therapy; Institutional Review Boards; International; Investigational Drugs; K-Series Research Career Programs; Laboratories; Leadership; Longevity; Medical center; Medicine; Mentors; Methods; Monitor; Multi-Institutional Clinical Trial; Neurologist; Neurology; Neurosciences; Pathology; Patient Recruitments; Pediatric Hospitals; Pennsylvania; Persons; Philadelphia; Physical Medicine; Physicians; Population; Postdoctoral Fellow; Presbyterian Church; Procedures; Protocols documentation; Psychiatry; Research; Research Infrastructure; Research Personnel; Residencies; Resources; SECTM1 gene; Scientist; Services; Site; Structure; Talents; Teaching Hospitals; Training; Training Programs; Universities; University Hospitals; Work; career; clinical center; clinical epidemiology; data quality; design; early experience; experience; human old age (65+); infancy; interest; medical schools; metropolitan; nervous system disorder; neurosurgery; participant retention; patient population; programs; recruit; success

The goal of the proposed Penn Center for Excellence in Neuroscience Clinical Trials (Penn NeuroNEXT) is to bring together and optimize the contributions of a large group of experienced investigators focused in the clinical neurosciences at the University of Pennsylvania Perelman School of Medicine (UPennSOM), across four major teaching hospitals: the Hospital of the University of Pennsylvania (HUP), the Children's Hospital of Philadelphia (CHOP), Pennsylvania Hospital (PAH) and Penn Presbyterian Medical Center (PPMC). UPennSOM has long been a leading Center for clinical research in the neurosciences, and internationally recognized leaders in neurology, neurosurgery, neuroradiology, and psychiatry have a strong track record of collaboration, evidenced by existing multiple program projects, collaborative agreements, successful participation in federally and industry-sponsored multi-center clinical trials, and a large number of investigator- initiated studies. The expertise of Penn NeuroNEXT investigators covers the lifespan, and they have been leading contributors to our understanding of and development of innovative therapies for neurological disorders from infancy through old age. Penn NeuroNEXT will leverage existing clinical research infrastructure and resources to efficiently Penn NeuroNEXT will contribute to NeuroNEXT by leveraging the expertise of senior leaders in the clinical neurosciences at Penn, as well as the enthusiasm and hard work from a large number of ambitious trainees and junior faculty. These goals are operationalized through the following three Specific Aims: Specific Aim 1: To be an outstanding enrolling site for NeuroNEXT trials. Penn NeuroNEXT will participate in a minimum of 4 NeuroNEXT clinical trials over the next 5 years. We intend to meet or exceed recruitment and retention goals. Specific Aim 2: To optimize efficiency of clinical research in neurosciences at UPennSOM. Penn NeuroNEXT will closely monitor progress of all NeuroNEXT trials, from site qualification, IRB submission, staff training, participant recruitment and retention, data quality assessment, and study closeout. Barriers to success will be identified early, and the experience and institutional influence of Penn NeuroNEXT leadership will be leveraged to overcome such barriers. We will insure that all ancillary services needed for successful participation in Network trials are available for each trial. These include the Investigational Drug Service (IDS), Center for Clinical Epidemiology and Biostatistics, Neuroradiology, Pathology and Laboratory Medicine. Specific Aim 3: To promote career enhancement of early stage clinical investigators. The University of Pennsylvania and our four hospitals are recognized as leading training centers in the clinical neurosciences, and we have been particularly successful in attracting talented young people interested in obtaining the necessary experience for launching academic careers.

拟议的宾夕法尼亚大学神经科学临床试验卓越中心(Penn NeuroNEXT)的目标是汇集并优化宾夕法尼亚大学佩雷尔曼医学院(UPennSOM)临床神经科学领域一大批经验丰富的研究人员的贡献，这些研究人员横跨四家主要教学医院：宾夕法尼亚大学医院(HUP)、费城儿童医院(CHOP)、宾夕法尼亚医院(PAH)和宾夕法尼亚长老会医学中心(PPMC)。长期以来，UPennSOM一直是神经科学临床研究领域的领先中心，神经学、神经外科、神经放射学和精神病学领域的国际公认领导者拥有良好的合作记录，现有的多个项目、合作协议、成功参与联邦和行业赞助的多中心临床试验以及大量由研究人员发起的研究证明了这一点。宾夕法尼亚大学神经NEXT研究人员的专业知识涵盖了生命周期，他们一直是我们了解和开发从婴儿期到老年的神经疾病创新疗法的主要贡献者。宾夕法尼亚州立大学NeuroNEXT将利用现有的临床研究基础设施和资源，高效地为NeuroNEXT做出贡献，利用宾夕法尼亚大学临床神经科学的高级领导者的专业知识，以及大量雄心勃勃的实习生和初级教员的热情和努力工作。这些目标通过以下三个具体目标得以实现：具体目标1：成为NeuroNEXT试验的杰出招募地点。宾夕法尼亚大学NeuroNEXT将在未来5年内参与至少4项NeuroNEXT临床试验。我们打算达到或超过招聘和留住目标。具体目标2：优化UPennSOM神经科学临床研究的效率。宾夕法尼亚州立大学NeuroNEXT将密切关注所有NeuroNEXT试验的进展，从现场资格、IRB提交、员工培训、参与者招募和保留、数据质量评估和研究结束。成功的障碍将被及早发现，宾夕法尼亚州立大学NeuroNEXT领导层的经验和机构影响力将被用来克服这些障碍。我们将确保成功参与网络试验所需的所有辅助服务可用于每一次试验。这些机构包括药物调查处、临床流行病学和生物统计学中心、神经放射学、病理学和检验医学。具体目标3：促进早期临床研究人员的职业提升。宾夕法尼亚大学和我们的四家医院被公认为临床神经科学领域的领先培训中心，我们在吸引有兴趣获得学术生涯所需经验的有才华的年轻人方面尤其成功。