Quality By Design: eCOA Improves Oversight & Data

Clinical outcome assessments (COAs) have played a significant role in measuring the efficacy of treatments tested in clinical trials for many years. In addition to showing the effectiveness of a particular treatment, COAs also reflect a participant's symptoms, general mental health, and quality of life.

As FDA commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”

Within the last decade, however, electronic clinical outcome assessments (eCOA) have begun replacing their hard copy forms. This shift from paper is attributed to eCOA's ability to facilitate data capture in a manner that better fits into participants’ lives while providing better data and easier experiences.

Learn how eCOA contributes to enhanced oversight and participant data quality through a quality-by-design approach.