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.

项目摘要 /摘要 NIH的Heal倡议旨在支持学术界临床研究专家与 行业加速发展高效，非添加性止痛药的慢性镇痛药 疼痛综合征。罗切斯特大学（UR）及其提议的领导型枢纽和发言人 在早期疼痛调查中，临床网络（EPPIC-NET）在设计和 进行小分子药物，设备和生物制剂的镇痛试验。这些试验都包括 研究者发动的2期试验和参与多站点行业赞助的临床试验具有主要 专注于良好的慢性下背痛（CLBP）综合征，这是该综合症的首要任务之一 NIH提议的Eppic-Net。目前，在UR中心有13个潜在的PIS PIS， 四个辐条。这些PI共同能够从 以下亚种：麻醉学，牙科，急诊医学，胃肠病学，妇科学， 神经病学，神经外科，肿瘤学，骨科，儿科，风湿病学和泌尿科。每个 承诺的潜在PI具有丰富的临床试验经验和现有基础设施以支持患者 招聘和保留，及时，准确的数据输入以及监管文件。另外， 拟议的Ur-Eppic-Net协作核心有能力使用 成员广泛，区域和国家镇痛研究人员网络。 UR有多个资源可以 促进有效的受试者招聘和试验质量，包括（1）UR临床和转化科学 研究所的试用中心联络小组和招聘部门，社区参与工作室和临床 研究中心； （2）基于实践的区域初级保健实践研究网络； （3） 人类主题保护办公室 - 质量改进部门。 UR也有多个资源 支持慢性疼痛患者的深层表型，包括（1）神经成像核心，（2） 神经肌肉病理实验室，（3）定量感觉测试专业知识和（4）体育锻炼 活动运动学实验室。 This proposal outlines a leadership and oversight infrastructure to allow for the Eppic-NET临床试验的灵活，高效和高完整性实施。机构领导 承诺包括使用中央机构审查委员会（IRB）和采用和 实施总审判协议模板。结果，拟议的UR-Eppic-NET集线器和 辐条非常适合与Eppic-NET数据和临床协调中心一起设计和 在各种疼痛条件下快速进行II期治疗试验，并设定新标准 用于疼痛研究的概念，实施和传播。