PROJECT SUMMARY/ABSTRACT Thousands of children in the United States receive treatment for acute pain each year, and even more experience pain that is unrecognized. The majority of those who are treated receive interventions that have not been proven to be safe or effective in children. Inadequately treated acute pain can lead to chronic pain and multiple adverse outcomes. Rigorous trials performed under a structured research and data ecosystem that address acute pediatric pain are urgently needed. To address this critical, unmet public health need, we will establish the Duke-Utah HEAL Kids Pain Resource and Data Center (Duke-Utah RDC). Our RDC will support multi-site clinical trials within the HEAL KIDS Acute Pain Clinical Trials (APCT) with the overarching goal of harmonizing these trials in an integrated program with shared objectives, procedures, and tools to maximize knowledge gained in pediatric pain. The Duke University Clinical Research Institute (DCRI) and The University of Utah, two powerhouses in clinical trial and data coordination with an established history of collaboration, are uniquely positioned to establish this RDC. We will leverage the capacity and experience of the world’s largest academic research organization, DCRI, and the pediatric trial and informatics expertise of the Utah DCC to integrate high-quality logistics and operations, experienced communications management, and sophisticated data and informatics solutions for the HEAL KIDS program. The faculty on our proposal, who include pediatricians with subspecialty expertise (Greenberg, Benjamin, Watt) and experts in informatics (Sward), will provide coordination, support, and consultation to HEAL KIDS program investigators and trial data coordinating centers, building their capacity to implement well-designed, efficient trials that produce high-quality, easily accessible data. To achieve this vision, we will establish 2 RDC cores: 1) a Data Curation and Harmonization Core; and 2) an Administrative and Communications Core. These cores will engage proactively with the ACPT trial teams, data coordinating centers, NIH, and other stakeholders to accomplish the following specific aims: 1) Create and sustain a harmonized HEAL KIDS Pain research and data ecosystem; 2) Facilitate compliant data sharing and seamless accessibility to maximize future research; and 3) Support effective communication within the program and to the broader research community. Our HEAL KIDS Pain research and data ecosystem will lay the foundation for the generation of harmonized data. We will ensure that these data are submitted to public use repositories and easily accessible to investigators through the use of sophisticated informatics tools. The Duke-Utah RDC will fuel the successful completion of the awarded APCT trials while maximizing the impact of the resulting data to ensure forward progress in the management of pediatric pain conditions. Our infrastructure will serve as a model and foundation for future pediatric pain trials.

PROJECT NARRATIVE Pain in children is common and inadequately treated due to the paucity of rigorous clinical trials and the absence of a sustainable research and data ecosystem for pediatric pain. This proposal represents a partnership between Duke Clinical Research Institute and The University of Utah. We will leverage our complementary strengths to establish the Duke-Utah HEAL KIDS Pain Resource and Data Center to ensure successful completion of pediatric acute pain trials and generation of high-quality, accessible data.