As patient-centerd research continues to shape clinical trial design, electronic patient-reported outcomes (ePROs) are increasingly being considered for use as primary endpoints. In a new article for the Journal of Clinical Studies, Barbara Arch, Principal Statistician at Phastar, examines the opportunities and challenges of using ePRO data in this way, drawing on learnings from three multi-center, multinational prevention trials in pediatric respiratory disease.
”While paper-based PROs have been used in clinical trials for many years, electronic (ePRO) collection has only become possible more recently. We now have the means through simple to use apps on hand-held devices to take measurements on-the-spot. This brings the potential for precise identification of the start and duration of symptom-related medical events. However, there are also challenges, including under-reporting or mis-reporting and missing data.”