The rise of eCOAs in the patient-centered health-care


Published 08 July 2019



Bill Byrom
Vice President, CRF Bracket , United Kingdom


Willie Muehlhausen
Digital Innovator, Managing Director/Founder
Muehlhausen Consulting, Ireland

Clinical research and patient care rely more and more on patient feedback. Real World Evidence data often includes a large amount of Patient Reported Data. New patient-focused drug development guidances demand greater inclusion of the patient voice in clinical research and patient-reported outcomes are more integral in labeling and market access activities for new treatments. For more than 20 years, the clinical research industry has utilized electronic systems to capture questionnaires from patients directly. Many aspects of this process have changed over time as we better understand patient motivation and as technology availability improves across patient populations.

This ever-evolving area of electronic Clinical Outcomes Assessments (eCOA) constantly requires from all of us involved to stay educated on the topic.

While there is a constant change in our understanding of the patient interaction with technology and the science behind migration across digital platforms, there are some operational constants and general research findings which we can use as a foundation to build from. Some general concepts have been established over many years and answers to questions like “Can elderly patients use eDiaries at home?” are well known, but not always easily accessible. Some newer concepts include Bring Your Own Device (BYOD) and Wearable Devices to capture data from patients directly.

Implementing eCOA in any clinical trial can be a complex and challenging process. Besides the technical aspects there are many more that need to be considered, such as author license agreements, translations, migrations and device distributions, to name just a few.


Bill and Willie have been involved in all aspects of eCOA implementation for more than 20 years and have helped organizations across the globe to successfully include eCOA in clinical research projects. They have also contributed significantly to the knowledge around new concepts i.e. Bring Your Own Device (BYOD), wearable technology and machine learning/artificial intelligence.