Why Choose Electronic Capture Of Patient-Reported Outcomes Data Instead Of Using Pen And Paper

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

Patient-reported outcomes (PROs) constitute a type of clinical outcome assessment (COA) designed to gauge a patient's feelings, functionality, or survival. Patient-reported outcome measures (PROMs) reflect the patient's health status directly, with no interpretation from clinicians or others.¹ Some symptoms, such as pain, fatigue, or nausea, can only be accurately assessed by the patient. Although initially used primarily for such symptoms, PROMs are now integral to drug development programs, offering insights into patients' perspectives on well-being, functionality, and treatment experiences. These measures are also gaining traction in supporting labeling claims.

Traditionally, PRO data was gathered through paper questionnaires during site visits or patient-completed paper diaries at home. However, with the prevalence of smartphones, tablets, and other mobile devices, electronic data capture solutions are now employed in over 50% of clinical trials collecting PRO data.

While regulatory bodies still accept PRO data collected on paper, the quality and integrity of such data, especially in unsupervised conditions like at-home completion of symptom diaries, are increasingly scrutinized. See how this method reduces data integrity and reliability with real-world examples in this recently updated white paper.