By Jonathan Pritchard, Director Business Development, Cytel
The field of Electronic Clinical Outcome Assessments ( eCOA) encompasses clinician reported, caregiver reported, or patient-reported outcomes to assess and evaluate the patient experience. Electronic patient-reported outcomes ( ePRO) as part of this broader umbrella, are essentially a validated set of questionnaires that are given to patients to assess subjective experiences; for example their experience of pain, their mood, whether they feel that they can walk a longer distance, climb higher sets of stairs etc.
In recent years, the entire field of ECOA has significantly matured. Initially, we used paper-based surveys. As technology has progressed and evolved, we are now able to deploy sleek applications on the patient’s own smartphone or a device provided by the eCOA provider. Nowadays, we can connect other data sources, such as wearables, photo sensors, diabetes monitors, and glucose monitors to collect the data on an ongoing, real-time basis.
With many trials now incorporating ePRO, let's walk through three critical considerations for sponsors when implementing these solutions into their trials.