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

华盛顿大学早期疼痛调查临床网络中心

基本信息

批准号：
10903640
负责人：
Michele Curatolo
金额：
$ 11.41万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-30 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10903640
关键词：
Affect Alaska Ambulatory Care Analgesics Behavioral Bioethics Biological Markers Caring Childhood Clinical Clinical Research Clinical Trials Clinical and Translational Science Awards Collaborations Communication Conduct Clinical Trials Consultations Data Development Dimensions Disease Elderly Epidemic Family Practice Geography Goals Health Helping to End Addiction Long-term Idaho Illinois Infrastructure Inpatients Laboratories Leadership Medical Medical center Medicine Military Personnel Monitor Montana Multi-Institutional Clinical Trial Operative Surgical Procedures Oregon Outpatients Pacific Northwest Pain Pain Clinics Pain Disorder Pain management Participant Patient Recruitments Patients Pediatric Hospitals Performance Phase Phase II Clinical Trials Phenotype Policies Population Principal Investigator Procedures Public Health Recording of previous events Research Research Personnel Research Support Resources Rural Population Safety Science Sensory Site Testing Training Training and Education Translational Research Underserved Population Universities Washington Work Writing Wyoming biomarker validation biopsychosocial cancer care clinical biomarkers clinical center clinical investigation clinical research site clinically significant design experience flexibility innovation medical specialties multidisciplinary neuroimaging opioid epidemic opioid misuse overdose death participant enrollment patient population phase II trial psychologic quality assurance recruit response skills translational health science validation studies

项目摘要

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.

项目概要阿片类药物滥用与相关的过量死亡流行和不充分的同时发生的公共卫生危机疼痛管理的选择需要创新、影响深远、安全和有效的解决方案。华盛顿大学 (UW) 疼痛医学科 (UW Pain) 是 EPPIC-Net 内的专业临床中心，代表太平洋西北地区及其他地区的华盛顿大学疼痛中心（“中心”）包括四个核心临床中心：华盛顿大学医疗中心、港景医疗中心、西雅图儿童医院和西雅图癌症护理联盟。 hub 由经验丰富的核心团队驱动，该团队利用现有基础设施和资源，确定了一个灵活、多样化且强大的分支站点网络，以帮助满足 EPPIC-Net 的广泛需求。我们的主要研究人员团队在进行多中心临床试验方面拥有丰富的相关经验跨越所有阶段和深度表型分析，例如行为和心理分析、定量该团队得到了感官测试、神经影像和生物标志物研究的进一步支持。协调员，并将与华盛顿大学转化健康科学研究所（ITHS）密切合作，该研究所是华盛顿大学转化健康科学研究所的所在地华盛顿大学相关部门提供临床和转化科学奖。我们的网络跨越多个州和专业，允许访问。地理和人口结构多样化（包括代表性不足和服务不足）的患者群体以及一系列以疼痛为临床重要组成部分的内科和外科疾病。为了实现 HEAL 计划 EPPIC-Net 的目标，我们： (1) 建立了 UW EPPIC-Net Hub 并辐射基础设施，提供科学领导和行政监督，并将我们的专业知识应用于设计和进行高质量的多学科 2 期临床试验和生物标志物验证研究 (2) 制定快速设计、启动、招聘、实施和结束高质量的政策和程序 UW Pain 针对特定疼痛状况的多学科 2 期临床试验和生物标志物验证研究 EPPIC-Net 中心和辐射点，以及 (3) 建立沟通、教育和培训机制，以及对 UW-EPPIC-Net Hub 和 Spoke 进行性能评估，以确保高效、及时地利用最有效地招募参与者的资源。