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

项目总结/摘要 NIH的HEAL计划旨在支持学术界的临床研究专家与 行业加速开发高效，非成瘾性镇痛剂，用于明确定义的慢性 疼痛综合征罗切斯特大学（UR）及其拟议的UR轴辐式领导 在早期疼痛研究临床网络（EPPIC-Net）中，在设计和 开展小分子药物、器械和生物制剂的镇痛试验。这些审判包括两个 制药商发起的2期试验和参与多中心行业申办的临床试验，主要 重点关注表型良好的慢性腰痛（CLBP）综合征，这是该领域的首要任务之一 美国国立卫生研究院提出的EPPIC网络。目前，在UR Hub有13个已提交的潜在协议PI， 四个辐条。这些PI一起能够招募具有广泛疼痛状况的受试者， 以下专科：麻醉科、牙科、急诊医学、胃肠病学、妇科学， 神经病学、神经外科学、肿瘤学、整形外科学、儿科学、风湿病学和泌尿学。这一切成功都 承诺的潜在PI具有丰富的临床试验经验和现有的基础设施，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。此外该 拟议的UR-EPPIC-Net协作核心已做好充分准备，可以使用 成员的广泛的，区域和国家的止痛药研究人员网络。UR拥有多种资源， 促进有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小组和招募部门、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） 人类受试者保护办公室-质量改进部门。工发组织代表还拥有多种资源， 支持慢性疼痛患者的深层表型，包括（1）神经影像学核心，（2） 神经肌肉病理学实验室，（3）定量感觉测试专业知识，和（4）体育锻炼 运动机能学实验室该提案概述了一个领导和监督基础设施， 灵活、高效、高度完整地实施EPPIC-Net临床试验。机构领导 承诺包括使用中央机构审查委员会（IRB）和采用， 实施总试行协议模板。因此，拟议的UR-EPPIC-Net Hub和 辐条处于有利地位，可以与EPPIC网络数据和临床协调中心合作， 快速开展II期治疗试验，以广泛的疼痛条件，并制定新的标准 疼痛研究的概念、实施和传播。

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.