Randomized clinical trials are considered the gold standard in clinical research. However, they often require a great deal of time and cost, and may not be feasible to conduct in vulnerable populations such as premature infants.
To overcome these difficulties, the Pediatric Trials Network (PTN) developed a repository of electronic health record (EHR) data gathered from nearly 265,000 pediatric patients to better guide research.
“This real-world data can be used to target drugs, conditions, and subpopulations for clinical studies that will maximize public health benefit and help identify areas for future study,” said Dr. Christoph Hornik of the Duke Department of Pediatrics, who led the development of the data repository.
The Best Pharmaceuticals for Children Act (BPCA) mandates the National Institutes of Health to prioritize areas where there is a critical need for information to guide medical treatments in children. With funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the PTN conducts studies designed to determine the dosing, safety, and efficacy of drugs that have been approved for adults but lack information for the pediatric population.
The repository, which includes data collected from 9 participating sites from 2013 to 2017, will aid in PTN’s mission by providing a multicenter data source to support its studies. It will facilitate both trial planning and the analysis of the uses and effects of a variety of medications in infants and children.
“Findings from this initiative will benefit children receiving care by not only shedding light on existing treatment practices, but also determining best practices for the future,” Hornik said.
The data collection, validation, and storage process was managed by Duke Health Technology Services and conducted in accordance with the Federal Information Security Management Act.