U of R Hub and Spokes for the EPPIC Network - Specialized Clinical Center

里约大学 EPPIC 网络的中心和分支 - 专业临床中心

• 批准号: 10888509
• 负责人: Jennifer Gewandter
• 金额: $ 9.06万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10888509
• 关键词: Academia; Acceleration; Address; Adoption; Agreement; Analgesics; Anesthesiology; Biological; Biological Markers; Biological Products; Caring; Chronic low back pain; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Network; Collaborations; Conceptions; Data; Dentistry; Development; Devices; Documentation; Emergency Medicine; Foundations; Gastroenterology; Goals; Gynecology; Helping to End Addiction Long-term; Industry; Infrastructure; Institution; Institutional Review Boards; Kinesiology; Laboratories; Leadership; Link; Medical center; Neurology; Oncology; Orthopedics; Pain; Pain Research; Pathology; Patient Recruitments; Pediatrics; Pharmaceutical Preparations; Phase; Phenotype; Physical Exercise; Positioning Attribute; Protocols documentation; Research; Research Infrastructure; Research Personnel; Resources; Rheumatology; Sensory; Site; Syndrome; Testing; Therapeutic Trials; Translational Research; United States National Institutes of Health; Universities; Urology; Work; chronic pain; chronic pain patient; clinical center; clinical investigation; community engagement; design; drug development; experience; human subject protection; improved; member; multidisciplinary; neuroimaging; neuromuscular; neurosurgery; novel; participant enrollment; patient retention; patient subsets; phase II trial; practice-based research network; primary care practice; recruit; small molecule

PROJECT SUMMARY / ABSTRACT The NIH's HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, non-addictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its proposed leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), have extensive expertise in designing and conducting analgesic trials of small molecule drugs, devices, and biologics. These trials have included both investigator-initiated phase 2 trials and participation multi-site industry-sponsored clinical trials with a main focus on well-phenotyped chronic low back pain (CLBP) syndromes, which is one of the top priorities for the NIH's proposed EPPIC-Net. Currently, there are thirteen committed potential protocol PIs at the UR Hub and four Spokes. Together these PIs have the ability to recruit subjects with a broad range of pain conditions from the following subspecialties: anesthesiology, dentistry, emergency medicine, gastroenterology, gynecology, neurology, neurosurgery, oncology, orthopedics, pediatrics, rheumatology, and urology. Each of these committed potential PIs has extensive clinical trial experience and existing infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation. In addition, the proposed UR-EPPIC-Net Collaboration Core is well equipped to recruit additional Spoke sites using the members' broad, regional and national network of analgesic researchers. UR has multiple resources to promote efficient subject recruitment and trial quality, including (1) the UR Clinical and Translational Science Institute's Trial Hub Liaison Team and Recruitment Unit, Community Engagement Studios, and Clinical Research Center; (2) the Practice-Based Research Network of regional primary care practices; and (3) the Office for Human Subject Protection – Quality improvement division. The UR also has multiple resources to support deep phenotyping of chronic pain patients, including (1) the Neuroimaging Core, (2) the Neuromuscular Pathology Laboratory, (3) quantitative sensory testing expertise, and (4) the Physical Exercise Activity Kinesiology Laboratory. This proposal outlines a leadership and oversight infrastructure to allow for the nimble, efficient, and high integrity implementation of EPPIC-Net clinical trials. Institutional leadership commitments include the use of a central Institutional Review Board (IRB) and the adoption and implementation of master trial agreements templates. As a result, the proposed UR-EPPIC-Net Hub and Spokes are well positioned to work with the EPPIC-Net Data and Clinical Coordination Centers to design and rapidly conduct phase II therapeutic trials across a broad range of pain conditions, and to set new standards for conception, implementation, and dissemination of pain research.

项目概要/摘要 NIH 的 HEAL Initiative 旨在支持学术界和临床研究专家之间的合作 行业加速开发高效、非成瘾性镇痛药，用于治疗明确的慢性病 罗切斯特大学 (UR) 及其提议的 UR Hub 和 Spokes 领导层 在早期疼痛调查临床网络 (EPPIC-Net) 内，在设计和设计方面拥有丰富的专业知识 进行小分子药物、装置和生物制剂的镇痛试验这些试验包括这两种药物。 研究者发起的 2 期试验和参与多地点行业赞助的临床试验，主要 重点关注表型良好的慢性腰痛 (CLBP) 综合征，这是该研究的首要任务之一 NIH 提议的 EPPIC-Net 目前，UR 中心有 13 个承诺的潜在协议 PI。 这些 PI 总共有能力从四个辐条中招募患有各种疼痛状况的受试者。 以下专科：麻醉科、牙科、急诊医学、胃肠科、妇科、 神经病学、神经外科、肿瘤学、骨科、儿科、风湿病学和泌尿科。 忠诚的潜在 PI 拥有丰富的临床试验经验和现有基础设施来支持患者 招聘和保留、及时准确的数据输入以及监管文件。 拟议的 UR-EPPIC-Net 协作核心配备齐全，可以使用 UR 成员广泛的区域和国家镇痛研究人员网络拥有多种资源。 促进高效的受试者招募和试验质量，包括 (1) UR 临床和转化科学 研究所的试验中心联络团队和招聘部门、社区参与工作室和临床 研究中心；(2) 区域初级保健实践研究网络；以及 (3) 人类受试者保护办公室 – 质量改进部门 UR 还拥有多种资源。 支持慢性疼痛患者的深层表型分析，包括 (1) 神经影像核心，(2) 神经肌肉病理学实验室，(3) 定量感觉测试专业知识，以及 (4) 体育锻炼 该提案概述了活动运动机能学实验室的领导和监督基础设施。 灵活、高效、高度诚信地实施 EPPIC-Net 临床试验的机构领导力。 承诺包括使用中央机构审查委员会（IRB）以及采用和 因此，拟议的 UR-EPPIC-Net Hub 和 Spokes 能够很好地与 EPPIC-Net 数据和临床协调中心合作来设计和 快速开展针对广泛疼痛病症的 II 期治疗试验，并制定新标准 用于疼痛研究的构思、实施和传播。