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: 10684372
• 负责人: CHRISTOPHER S. COFFEY
• 金额: $ 7.73万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10684372
• 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; biopsychosocial factor; 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; pain chronification; 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.

项目摘要/摘要 从急性到慢性疼痛的过渡已经使研究人员多年了，这可能是由于其复杂的性质和 固有的个人变异性。识别有风险的人的能力以及风险降低的人的能力 使用生物标志物过渡到慢性疼痛将提高个性化的急性疼痛治疗策略，减少 依赖阿片类药物疗法，并有助于识别新型的治疗靶标，从而改变了 急性疼痛事件的管理。急性到慢性疼痛特征（A2CPS）计划旨在识别 生物标志物及其集体生物签名（几种单个生物标志物的组合）预测 通过急性疼痛事件后，对慢性疼痛发展的敏感性或韧性 大型财团的发展。多站点观察研究的优点是它们的能力 在相对较多的多个生物心理社会领域中，全面的表型人群大群人队列 短时间。该应用程序描述了强大的疼痛科学家之间的伙伴关系（Sluka，Frey 法律）和临床试验统计和数据管理中心（Coffey，Ecklund） 爱荷华州。拟议的CCC采用彻底且组织良好的原则来促进，支持和增强 关键利益相关者在识别急性的关键生物标志物方面的科学严谨性和有效性 慢性疼痛转变，使用以下基于任务的特定目的：1）领导发展和 实施临床方案。 2）提供监督和管理协作活动 联盟支持A2CP的整体目标。 3）促进透明有效的沟通 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 设计以帮助识别生物标志物进行研究包容；通过开发提高效率和质量 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）；并召集数据安全和监视 董事会（DSMB）。 CCC将跟踪协议质量控制程序和安全监控；执行中心 监视和现场监视访问；并监视朝着A2CP的里程碑，尤其是站点 - 特定的注册和保留目标，这是A2CPS计划成功的关键组成部分。这 A2CPS计划的成功取决于有效管理和协调活动 财团。我们已经组建了一个跨越疼痛科学的专业知识，患者的临床试验 疼痛和其他条件以及成功的大型多站点试验协调。爱荷华大学有一个 与强大的疼痛科学研究人员高度协作环境，使我们做好了成功的准备 执行A2CPS临床协调中心的许多必要角色。