Early Phase Pain Investigation Clinical Network Hub at the University of Washington

项目摘要 阿片类药物滥用与相关的过量死亡流行病和不适当的 疼痛管理的选择需要创新、深远、安全和有效的解决方案。大学 华盛顿（UW）疼痛医学部（UW疼痛）是EPPIC网络内的专业临床中心， 代表太平洋西北地区和其他地区。UW Pain（“枢纽”）包括四个核心临床站点： 医疗中心，哈博维尤医疗中心，西雅图儿童医院和西雅图癌症护理联盟。的 Hub由经验丰富的核心团队驱动，该团队充分利用了现有的基础架构和资源， 确定了一个灵活、多样和强大的分支站点网络，以帮助满足EPPIC网络的广泛需求。 我们的主要研究者团队在开展多中心临床试验方面具有丰富的相关经验 在所有阶段和深表型，如行为和心理分析，定量 感官测试、神经成像和生物标记物研究。该团队得到了研究的进一步支持 协调员，并将与华盛顿大学的转化健康科学研究所（CIMIS），华盛顿大学的网站密切合作。 临床和转化科学奖。相关的UW部门提供获得疾病特异性 专业知识和患者群体。我们的网络跨越多个州和专业，允许访问 地理和人口统计学上多样化（包括代表性不足和服务不足）的患者人群 以及疼痛是其临床重要组成部分的广泛的内科和外科疾病。到 为了实现HEAL倡议的EPPIC网络的目标，我们已经：（1）建立了UW EPPIC网络中心， 轮辐式基础设施，提供科学领导和行政监督，并运用我们的专业知识， 设计和开展高质量的多学科II期临床试验和生物标志物验证研究;（2） 制定了快速设计、启动、招聘、开展和关闭高质量 UW Pain针对特定疼痛状况的多学科II期临床试验和生物标志物验证研究 （3）建立通信、教育和培训机制， UW-EPPIC-Net Hub and Spokes的性能评估，以确保有效和及时地利用 以最有效地招募参与者。

PROJECT SUMMARY The concurrent public health crises of opioid misuse with associated overdose death epidemic and inadequate options for pain management require innovative, far-reaching, safe and effective solutions. The University of Washington’s (UW) Division of Pain Medicine (UW Pain) is a Specialized Clinical Center within EPPIC-Net, representing the Pacific Northwest region and beyond. UW Pain (“hub”) includes four core clinical sites: UW Medical Center, Harborview Medical Center, Seattle Children’s Hospital, and Seattle Cancer Care Alliance. The hub is driven by an experienced core team that has leveraged existing infrastructure and resources and identified a flexible, diverse, and robust network of spoke sites to help meet the broad needs of EPPIC-Net. Our team of principal investigators has extensive relevant experience in conducting multi-site clinical trials across all phases and in deep phenotyping, such as behavioral and psychological profiling, quantitative sensory testing, neuroimaging, and biomarker research. The team is further supported by research coordinators and will work closely with UW’s Institute for Translational Health Sciences (ITHS), the site of UW’s Clinical and Translational Science Award. Relevant UW departments affords access to disease-specific expertise and patient populations. Our network spans multiple states and specialties, allowing access to geographically and demographically diverse (including underrepresented and underserved) patient populations and a broad range of medical and surgical disorders for which pain is a clinically significant component. To achieve the goals of the HEAL initiative’s EPPIC-Net, we have: (1) Established UW EPPIC-Net Hub and Spokes infrastructure, provide scientific leadership and administrative oversight, and apply our expertise in design and conduct of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies; (2) Developed policies and procedures for rapid design, initiation, recruitment, conduct, and closure of high quality multidisciplinary Phase 2 clinical trials and biomarker validation studies for specific pain conditions at UW Pain EPPIC-Net Hub and Spokes, and; (3) Established mechanisms for communication, education and training, and performance assessment of the UW-EPPIC-Net Hub and Spokes, to assure efficient and timely utilization of resources to most effectively recruit participants.