Patient-reported outcome (PRO) endpoints are often necessary to adequately evaluate the treatment benefit provided by new medical products (e.g., drugs) in clinical trials.

The movement from paper-based to electronic PRO (ePRO) data collection has enhanced the integrity and accuracy of PRO data in clinical trials.

The US Food and Drug Administration has made it clear that electronic capture of clinical trial source data is preferred over paper-based data collection.

The bring your own device (BYOD) approach to ePRO data collection in clinical trials has considerable promise, but a number of questions need to be answered prior to its routine adoption.