Clinical Coordinating Center for the Acute to Chronic Pain Signatures Program

急性至慢性疼痛特征计划临床协调中心

• 批准号: 9812471
• 负责人: CHRISTOPHER S. COFFEY
• 金额: $ 101.31万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9812471
• 关键词: Acute; Acute Pain; Acute pain management; Animals; Basic Science; Biological Markers; Clinical; Clinical Protocols; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Communication; Complex; Development; Effectiveness; Electronic Health Record; Electronic Mail; Enrollment; Event; Future; Goals; Human; Image; Individual; Institutional Review Boards; Iowa; Islets of Langerhans Transplantation; Laws; Lead; Leadership; Logistics; Monitor; Musculoskeletal Pain; Nature; Observational Study; Opioid; Pain; Pain management; Parkinson Disease; Patient Outcomes Assessments; Patients; Persons; Pharmacotherapy; Phenotype; Population; Positioning Attribute; Postoperative Pain; Predisposition; Procedures; Protocols documentation; Quality Control; Recording of previous events; Research; Research Design; Research Personnel; Risk; Role; Sampling Studies; Science; Scientific Advances and Accomplishments; Scientist; Sensory; Site; Site Visit; Spinal Muscular Atrophy; Standardization; Techniques; Teleconferences; Testing; Time; Training; United States National Institutes of Health; Universities; Update; Visit; base; biopsychosocial; biosignature; candidate marker; chronic pain; clinical implementation; cohort; collaborative environment; data management; design; experience; high throughput screening; individual variation; meetings; member; multi-site trial; new therapeutic target; opioid abuse; prevent; procedure safety; programs; progression marker; psychologic; recruit; resilience; success; symposium; synuclein; tool; translational clinical trial; treatment strategy; virtual

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.

项目总结/摘要 从急性疼痛到慢性疼痛的转变多年来一直困扰着研究人员，这可能是由于其复杂的性质， 固有的个体差异。识别风险个体和风险降低个体的能力， 使用生物标志物向慢性疼痛过渡将推进个性化的急性疼痛治疗策略， 依赖阿片类药物治疗，并帮助确定新的治疗靶点，从而改变 急性疼痛事件的管理。急性至慢性疼痛特征（A2 CPS）计划旨在识别 生物标志物和它们的集体生物特征（几个单独的生物标志物的组合）， 急性疼痛事件后，通过 发展一个大财团。多中心观察性研究的优势在于， 综合表型的大型人群队列跨越多个生物心理社会领域， 短时间该应用程序描述了一个强大的疼痛科学家（Sluka，Frey 法律）和临床试验统计和数据管理中心（科菲，埃克隆德）在大学 爱荷华州。拟议的共同核心承诺采用全面和组织良好的原则，以促进、支持和加强 关键利益相关者的科学严谨性和有效性，以确定急性心肌梗死的关键生物标志物， 慢性疼痛过渡，使用以下基于任务的具体目标：1）领导发展和 实施临床方案。2)监督和管理跨部门的协作活动 支持A2 CPS的总体目标。（3）促进透明和有效的沟通 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， 有助于识别研究纳入的生物标志物的设计;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：电子健康标准化 记录;协调中央机构审查委员会（cIRB）;并召开数据安全和监测委员会会议 委员会（DSMB）。CCC将跟踪方案质量控制程序和安全性监测; 监测和现场监测访问;并监测A2 CPS里程碑的进展情况，特别是现场- 具体的招生和保留目标，在A2 CPS计划的成功的关键组成部分。的 A2 CPS计划的成功取决于有效管理和协调跨部门的活动， 财团。我们组建了一个专业团队，涵盖疼痛科学，患者临床试验， 具有疼痛等条件，并成功进行大型多部位试验协调。爱荷华州大学有一个 高度协作的环境与强大的疼痛科学研究人员，使我们做好准备，成功地 履行A2 CPS临床协调中心的许多必要角色。