EPPIC-Net Hub at University of Washington

项目摘要 同时出现的阿片类药物滥用和相关的过量死亡流行的公共卫生危机，以及疼痛管理选择不足，都需要创新、深远、安全和有效的解决办法。帮助结束成瘾长期(Heal)倡议的早期疼痛调查临床网络(EPPIC-NET)是一个独特的机会，通过快速发现和验证生物标记物和止痛疗法，以及深入的表型，影响疼痛的管理。华盛顿大学疼痛医学部(UW Pain)已经做好准备，将成为EPPIC-Net内的一个专业临床中心，代表太平洋西北地区和其他地区。UW Pain(“HUB”)包括四个核心临床站点：UW医学中心、港景医学中心、西雅图儿童医院和西雅图癌症护理联盟。该中心将由经验丰富的核心团队推动，以利用现有的基础设施和资源，并已确定了一个灵活、多样化和强大的辐条站点网络，以满足EPPIC-Net的广泛需求。我们的主要研究人员团队在所有阶段进行多点临床试验和深度表型分析方面拥有丰富的相关经验，例如行为和心理特征分析、定量感觉测试、神经成像和生物标记物研究。我们的合作研究人员是在临床试验指导和不同临床人群的多维表型方面经验丰富的科学家。一支由经验丰富的临床研究人员组成的多元化跨专业团队将在我们的咨询委员会中服务，以制定努力以优化我们的中心辐射式网络，而临床站点主管将促进访问各自临床站点的患者。该团队将得到研究协调员的进一步支持，并将与密歇根大学的转化健康科学研究所(ITHS)密切合作，该研究所是密歇根大学临床和转化科学奖的举办地。威斯康星州大学的相关部门将提供针对疾病的专业知识和患者群体，承诺的发言人包括特殊护理诊所、初级保健诊所、外部学术医疗中心和卫生系统。我们的网络跨越多个州和专科，使您能够接触到地理和人口统计学上不同的(包括代表性不足和服务不足的)患者群体，以及广泛的内外科疾病，其中疼痛是临床上重要的组成部分。为了实现Hear计划的EPPIC-Net目标，我们将：(1)建立UW EPPIC-Net枢纽和Spokes基础设施，提供科学领导和行政监督，并应用我们在设计和进行高质量多学科第二阶段临床试验和生物标记物验证研究方面的专业知识；(2)为UW Pain EPPIC-Net Hub和Spokes针对特定疼痛情况快速设计、启动、招募、进行和关闭高质量多学科第二阶段临床试验和生物标记物验证研究制定政策和程序；以及；(3)建立UW-EPPIC-Net中心和Spokes的沟通、教育和培训以及绩效评估机制，以确保高效和及时地利用资源，以最有效地进行招聘。

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 Help End Addiction Long-term (HEAL) initiative's Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a unique opportunity to impact the management of pain, through expeditious discovery and validation of biomarkers and analgesic therapies, and in-depth phenotyping. The University of Washington's (UW) Division of Pain Medicine (UW Pain) is well poised to become 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 will be driven by an experienced core team to leverage existing infrastructure and resources and has identified a flexible, diverse, and robust network of spoke sites to 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. Our Co-Investigators are scientists with experience in clinical trial conduct and multidimensional phenotyping across varied clinical populations. A diverse interprofessional team of seasoned clinical researchers will serve on our Advisory Board to strategize efforts to optimize our hub and spoke network, while Clinical Site Chiefs will facilitate access to patient at their respective clinical site. The team will be 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 will afford access to disease-specific expertise and patient populations, Committed spokes include specialty care clinics, primary care clinics, external academic medical centers and health systems. 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 will: (1) Establish 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) Develop 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) Establish 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.