Diaries used for electronically generated patient data are time-stamped, legible and logical. Because ePro makes information available in real time, it eliminates manual data entry and other data point changes and shortens trials, often making final data analysis available within days of a trial’s conclusion. By reducing data variance, fewer patients are required, especially in Phase II trials, making scientific outcomes more conclusive. Study leaders can even access patient data between patient visits. Though ePRO still requires accurate data review and monitoring, it enables trial sponsors to use fewer patients and reach go/no-go decisions more quickly.
ePRO is particularly valuable in multi-site international trials, because it makes it possible to monitor realtime status reporting, both overall and per site, as well as participant status tracking and on-demand subject randomization -- all via the Internet.