Abstract

The emergence of technologies that enable the direct electronic capture of patient-reported outcome (PRO) data has been a profoundly significant innovation in PRO endpoint assessment in clinical trials. Based on evidence that has been mounting over the past 20 years, paper-based self-reports of measurements (e.g., peak flow values) and experiences or sensations (e.g., symptoms) are far from optimal compared with data collected electronically. As stated by Ganser et al., paper-based approaches to patient-reported data collection can “result in untimely, unreadable, missing, illogical or otherwise faulty data” . In contrast, electronic data collection systems can lead to more accurate and complete data, avoidance of secondary data entry errors, easier implementation of skip patterns, less administrative burden, and potential cost savings