Barbara Arch, Principal Statistician at Phastar, discusses the use opportunities and challenges of using electronic patient reported outcomes (ePROs) for primary endpoints and shares learnings from three multi-centre multinational prevention trials in the field of childhood respiratory disease.

Patient reported outcomes (PROs) are gaining increasing importance in clinical trials, as part of a broader shift towards patient centred research. Because PROs come directly from the patient or carer, without interpretation by a clinician, they offer a unique real time perspective on the implications of treatment regarding aspects of health that are important to patients.

While paper-based PROs have been used in clinical trials for many years, electronic (ePRO) collection has only become possible more recently. We now have the means through simple to use apps on hand-held devices to take measurements on-the-spot. This brings the potential for precise identification of the start and duration of symptom-related medical events. However, there are also challenges, including under-reporting or mis-reporting and missing data.