ePRO Systems Validation- Clearly Defining the Roles of Clinical Trial Teams and ePRO System Providers

Jun 1, 2013, 00:00 AM
10.1016/j.jval.2013.04.006
https://www.valueinhealthjournal.com/article/S1098-3015(13)01804-4/fulltext
Section Title : Editorials
Section Order : 27
First Page : 457
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
https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(13)01804-4&doi=10.1016/j.jval.2013.04.006
HEOR Topics :
  • Patient-Centered Research
  • Patient-reported Outcomes & Quality of Life Outcomes
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Regions :
  • Global