Clinical Coordinating Center for the Acute to Chronic Pain Signatures Program

项目摘要/摘要 多年来，研究人员一直未能从急性疼痛过渡到慢性疼痛，这可能是由于其复杂的性质和 与生俱来的个体差异。识别处于风险中的个人以及风险降低的个人的能力 使用生物标记物过渡到慢性疼痛将推进个性化急性疼痛治疗策略，减少 依赖阿片类药物治疗，并帮助确定新的治疗靶点，从而转变 急性疼痛事件的管理。急性到慢性疼痛信号(A2CPS)计划旨在识别 生物标记物及其集体生物签名(几个单独生物标记物的组合) 对急性疼痛事件后慢性疼痛发展的敏感性或弹性通过 发展一个大型财团。多点观测研究的优势在于它们能够 跨多个生物、心理和社会领域的综合表型大群体队列 做爱。这个应用程序描述了一组强大的疼痛科学家(Sluka，Frey 法学院)和临床试验统计和数据管理中心(科菲，埃克伦德) 爱荷华州。拟议的协调中心采用周密和有组织的原则，以促进、支持和加强 关键利益相关者在确定急性到非传染性疾病关键生物标志物方面的科学严谨性和有效性 慢性疼痛过渡，使用以下基于任务的特定目标：1)领导发展和 执行临床方案。2)监督和管理跨部门的协作活动 支持A2CPS总体目标的财团。3)促进透明和有效的沟通 在财团成员之间。CCC将支持研究设计，带来疼痛和适应性方面的专业知识 帮助确定纳入研究的生物标记物的设计；通过开发 里程碑、标准操作程序(SOP)、个性化招聘计划和员工培训 协议。CCC将负责监管程序，包括：标准化电子健康 记录；协调中央机构审查委员会(CIRB)；召开数据安全和监测会议 主板(DSMB)。CCC将跟踪协议质量控制程序和安全监控；执行中央 监测和现场监测访问；监测实现A2CPS里程碑的进展情况，特别是现场-- 具体的登记和保留目标，这是A2CPS倡议成功的关键组成部分。这个 A2CPS计划的成功取决于对以下各项活动的有效管理和协调 财团。我们已经组建了一支拥有疼痛科学、患者临床试验等专业知识的团队 配合疼痛等条件，成功进行大剂量多点试验配合。爱荷华大学有一项 与强大的疼痛科学研究人员高度协作的环境，使我们为成功做好准备 履行A2CPS临床协调中心所需的许多角色。

PROJECT SUMMARY/ABSTRACT The transition from acute to chronic pain has eluded researchers for years, likely due to its complex nature and the inherent individual variability. The ability to identify individuals at risk, and those with reduced risk, for the transition to chronic pain using biomarkers will advance personalized acute pain treatment strategies, reduce reliance on opioid pharmacotherapy, and help identify novel therapeutic targets, thereby transforming the management of acute pain events. The Acute to Chronic Pain Signatures (A2CPS) Program aims to identify biomarkers and their collective biosignatures (a combination of several individual biomarkers) that predict susceptibility or resilience to the development of chronic pain after an acute pain event through the development of a large consortium. The advantage of multisite observational studies is their ability to comprehensively phenotype large population cohorts across multiple biopsychosocial domains in a relatively short time. This application describes a partnership between a strong group of pain scientists (Sluka, Frey Law) and the Clinical Trials Statistical and Data Management Center (Coffey, Ecklund) at the University of Iowa. The proposed CCC applies thorough and well-organized principles to facilitate, support and enhance the scientific rigor and effectiveness of key stakeholders for the identification of critical biomarkers for the acute to chronic pain transition, using the following task-based specific aims: 1) Lead the development and implementation of clinical protocols. 2) Provide oversight and management of collaborative activities across the consortium to support the overall goals of A2CPS. And 3) Facilitate transparent and effective communication between consortium members. The CCC will support study design, bringing expertise in pain and adaptive designs to help identify biomarkers for study inclusion; promote efficiency and quality through development of milestones, Standard Operating Procedures (SOPs), individualized recruitment plans, and staff training protocols. The CCC will be responsible for regulatory procedures including: standardizing the electronic health record; coordinating a central Institutional Review Board (cIRB); and convening a Data Safety and Monitoring Board (DSMB). The CCC will track protocol quality control procedures and safety monitoring; perform central monitoring and on-site monitoring visits; and monitor progress towards A2CPS milestones, particularly site- specific enrollment and retention targets, a critical component in the success of the A2CPS initiative. The success of the A2CPS Program is dependent on effective management and coordination of activities across the Consortium. We have assembled a team with expertise spanning pain science, clinical trials in patients with pain and other conditions, and successful large multi-site trial coordination. The University of Iowa has a highly collaborative environment with strong pain science researchers, making us well prepared to successfully perform the many needed roles of the A2CPS Clinical Coordination Center.