Paper Vs ePRO: Clinical Data Collection Methods

By Bill Byrom, Ph.D., Principal, eCOA Science, Signant Health UK

Patient-reported outcomes (PROs) are a type of clinical outcome assessment (COA) that measure how a patient feels, functions, or survives. Patient-reported outcome measures (PROMs) are reports directly from patients about their health conditions, without interpretation by clinicians or others. For certain symptoms like pain, fatigue, or nausea, only the patient can accurately assess their condition. However, the utility of PROMs extends beyond these areas, increasingly being incorporated into drug development programs to capture patients' perspectives on their well-being, functioning, and treatment experiences. PROMs are also being used more frequently to support labeling claims.

Traditionally, PRO data was collected using paper questionnaires during site visits or paper diaries completed at home. Today, with the widespread availability of smartphones, tablets, and other mobile devices, over 50% of clinical trials collecting PRO data use electronic data capture solutions. While paper-based PRO data is still accepted by regulatory bodies, the quality and integrity of this data—particularly from unsupervised at-home symptom diaries—are facing greater scrutiny.

This article reviews the limitations of using paper to collect PRO data and explores the advantages of electronic data collection.