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.

Project Narrative The University of Washington's (UW) Division of Pain Medicine (UW Pain) is well poised to become a Specialized Clinical Center within the HEAL Initiative's Early Phase Pain Investigation Clinical Network. Its breadth and depth of pain expertise, functional infrastructure, accessible resources, established UW affiliated networks and inter-state collaborations that provide access to geographically and demographically diverse patient populations, and a broad range of medical and surgical disorders for which pain is a clinically significant component provide support for UW Pain as a highly effective Specialized Clinical Center. The UW EPPIC-Net Hub and Spokes infrastructure will provide scientific leadership and administrative oversight of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies, develop policies and procedures for rapid design, initiation, recruitment, conduct, and closure of these studies throughout the hub-spoke network, and establish mechanisms for communication, education and training, and performance assessment to assure efficient and timely utilization of resources.