Looking Back to Go Forward: Reintegrating Scientific Considerations Into eCOA Design and Implementation
Author(s)
Lindsay Hughes, PhD1, Erieta Bountouva, MSc2, Matthew Reaney, BSc, MSc, PhD3.
1IQVIA, Haleiwa, HI, USA, 2IQVIA, Madrid, Spain, 3IQVIA, Reading, United Kingdom.
1IQVIA, Haleiwa, HI, USA, 2IQVIA, Madrid, Spain, 3IQVIA, Reading, United Kingdom.
OBJECTIVES: Commoditization of eCOA has allowed for widespread adoption, offering significant potential for enhancing patient engagement and improving data quality. However, realizing this value depends on scientifically grounded strategies and context-sensitive operational execution. As eCOA becomes more ubiquitous, there is a growing risk that scientific and operational rigor may be deprioritized, undermining its full potential in clinical trials.
METHODS: We conducted a structured literature review to answer: (1) Is “modern” eCOA systematically informed by scientific research to ensure reliability and validity of eCOA data? (2) Are “modern” eCOA solutions designed to enhance patient engagement and reduce site burden? (3) How is “modern” eCOA monitored? Searches were performed in PubMed and Google Scholar, and publication libraries from relevant pre-competitive consortia using terms such as eCOA, ePRO, patient engagement, site training, and data completeness. Four reviewers screened abstracts and selected 65 English-language articles (1998-2025) for full review.
RESULTS: Modern eCOA is not systematically informed by scientific research. Early eCOA development relied on empirical evidence, emphasizing behavioral science to support compliance and data quality, but recent literature has moved away from hypothesis testing and toward repetition of best practices. User-friendly interfaces, flexible data collection, and real-time feedback were found to enhance patient engagement and reduce site burden. Incorporating patient feedback and tailored training improved compliance and data quality. Continuous remote monitoring and automated alerts supported early detection of missing data and improved data completeness.
CONCLUSIONS: Re-centering eCOA design on its scientific foundations—through rigorous research, patient and site feedback - and focusing on operational implementation such as continuous remote monitoring, will ensure that modern eCOA will produce reliable, valid and valuable data from clinical trials. Cutting corners leads to compromised data quality and integrity. By looking back at foundational principles, we can move forward with more robust, patient-centered, and scientifically grounded eCOA implementations.
METHODS: We conducted a structured literature review to answer: (1) Is “modern” eCOA systematically informed by scientific research to ensure reliability and validity of eCOA data? (2) Are “modern” eCOA solutions designed to enhance patient engagement and reduce site burden? (3) How is “modern” eCOA monitored? Searches were performed in PubMed and Google Scholar, and publication libraries from relevant pre-competitive consortia using terms such as eCOA, ePRO, patient engagement, site training, and data completeness. Four reviewers screened abstracts and selected 65 English-language articles (1998-2025) for full review.
RESULTS: Modern eCOA is not systematically informed by scientific research. Early eCOA development relied on empirical evidence, emphasizing behavioral science to support compliance and data quality, but recent literature has moved away from hypothesis testing and toward repetition of best practices. User-friendly interfaces, flexible data collection, and real-time feedback were found to enhance patient engagement and reduce site burden. Incorporating patient feedback and tailored training improved compliance and data quality. Continuous remote monitoring and automated alerts supported early detection of missing data and improved data completeness.
CONCLUSIONS: Re-centering eCOA design on its scientific foundations—through rigorous research, patient and site feedback - and focusing on operational implementation such as continuous remote monitoring, will ensure that modern eCOA will produce reliable, valid and valuable data from clinical trials. Cutting corners leads to compromised data quality and integrity. By looking back at foundational principles, we can move forward with more robust, patient-centered, and scientifically grounded eCOA implementations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR150
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance, Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas