Clinical Coordinating Center for the Acute to Chronic Pain Signatures Program

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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.