With the need to incorporate remote ways of working and interacting with study participants, sponsors and contract research organizations (CROs) have turned to technology for critical study activities ranging from patient consent and consultation to site monitoring. A particular instance of increased technology uptake has been in the area of patient-reported outcome (PRO) data collected by electronic methods, known as electronic PRO (ePRO) data.
Background
The U.S. Food and Drug Administration (FDA) defines a PRO as “any report of the status of patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”1 Historically, PRO data has been used as an adjunct to primary data in the context of clinical trials. However, due in part to the emergence of the COVID-19 pandemic, sponsors have increased their reliance on PRO data in order to maintain trial continuity. In particular, the need to gather data remotely has catapulted ePRO data to the forefront.
Benefits of ePROs
Using ePRO data can help maintain clinical trial integrity and, even outside the context of COVID-19, will continue to be a valuable adjunct data collection tool for studies that aim to capture information about the patient experience.
ePROs are designed to optimize the objectivity of inherently subjective data. Compared to paper-based PROs, ePROs offer a number of potential advantages, such as: