Duke-Utah HEAL KIDS Pain Resource and Data Center

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.