Case Study

A New Model For Patient-Reported Outcomes

Source: Medidata Solutions
mobile-devices+cloud technology

Why in this day and age, with people connected 24x7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments.

Despite the site burden & costs
Although a known entity, paper is not an easy medium to work with. Sites have to concern themselves with the logistics, transcription and archiving of the physical assets. Sponsors have to budget for these activities as well as having monitors perform source data verification (SDV).

Despite regulatory guidance
Janet Woodcock, director of the Center for Drug Evaluation & Research (CDER), stated recently that “Data quality in general needs industry’s attention.” The FDA, for example, “promotes capturing source data in electronic form.”