Paper-based patient-reported outcomes (pPROs) remain a popular means of data collection in clinical trials due to their lower setup costs when compared to electronic PROs (ePROs), although the cost-saving benefits of ePROs rapidly eclipse the initial savings made through pPROs. Furthermore, compliance rates for ePROs range from 90% to 97%, compared to the 30% or lower compliance rate seen for pPROs.
The US Food and Drug Administration (FDA) has made it clear that electronic capture of clinical trial source data over paper-based data collection is the preferred option.
It has been almost a decade since the FDA made their preferences known, so why do sponsors and contract research organisations (CROs) continue to choose pPROs, when the evidence suggests that ePROs are cheaper and more effective in the long term?