eCOA: Has It Lived Up to the Promise? A Realistic Assessment for Today’s Trials

Despite two decades of technological advancement, the debate between paper and electronic clinical outcome assessments (eCOA) remains surprisingly unresolved; despite the evidence available. This session revisits the foundational assumptions that have shaped data collection strategies in clinical research, and asks whether current practice reflects the state of the science or the weight of institutional habit.

The early promise of eCOA was well-founded. Electronic instruments offered real-time data capture, reduced transcription error, improved compliance monitoring, and greater auditability. Yet adoption has been uneven, and resistance has persisted, often anchored to concerns that were legitimate in 2005 but have since been substantially addressed. This session examines that gap between perception and current capability.

A recurring point of inquiry is the framing of paper as the “standard we’ve always used” of outcome assessment. This, however, raises the legitimate question as to “are we holding paper COA to the same standards as electronic? Are we creating complexities that we don’t enforce with paper?”

Paper-based patient-reported outcome data capture does carry a known risk of incomplete and error-prone data capture. Illegible entries, missing data, protocol deviations identified only at database lock, and the fundamental impossibility of verifying when data was actually recorded. The industry has developed rigorous validation frameworks for electronic instruments, yet comparably systematic standards have not been applied to paper. This asymmetry deserves acknowledgment.

This is not to say that paper is obsolete; indeed, this session identifies the specific contexts in which paper remains a capable, defensible, and at times preferable modality – including some rare disease studies, small patient cohorts,  and populations with genuine device-use barriers, and instruments of limited complexity. The objective is precision, not advocacy.

On the technology side, the session surveys the distance travelled since the early days of provisioned handheld devices. Build timelines, translation workflows, and screenshot review processes have all been substantially transformed. The emergence of agentic AI has further accelerated eCOA development and deployment, reducing the manual burden that once made electronic implementation a significant operational undertaking.

Attendees will leave with an evidence-informed framework for modality selection, one grounded in current capabilities rather than assumptions formed when the field was still calibrating to a new paradigm.

Register for this webinar to learn how eCOA in clinical research can improve data quality, strengthen compliance monitoring and support evidence-informed modality selection.

Speakers

Mark Wade, Global Practice Leader & COA SME, TransPerfect Life Sciences

Mark P. Wade is the Global Practice Leader at TransPerfect Life Sciences, the largest language translation company globally, where he serves as the resident SME for all patient-facing clinical trial processes and translation. Mr. Wade has 20 years of experience in life sciences, including serving as International Regional Director for EMEA at Ethicon and Ethicon Endo-Surgery, a Johnson & Johnson company (NYSE: JNJ). For nearly 10 years, Mr. Wade served as Global Practice Leader at another global language translation company. He is a published expert in electronic clinical outcome assessments (eCOA), including two eBooks, as well as clinical services, patient recruitment and site selection. He has also authored clinical posters and numerous articles in trade journals. Mr. Wade has chaired sessions, presented and published posters at ISPOR and ISOQOL annual symposia, as well as numerous other internationally recognized conferences. He is a past industry Co-Director and an active Committee Member of the C-Path eCOA Consortium, the ISOQOL Translation & Cultural Adaptation (TCA) Special Interest Group (SIG) and the ISPOR Digital Health (DH) SIG.

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Paul O’Donohoe, Director, eCOA Product and Science, Medidata Solutions

Paul O’Donohoe is currently a Senior Director of eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata’s electronic clinical outcome assessment technologies and supporting internal teams and partners in implementing industry, regulatory and scientific best practices in clinical trials using mobile health technologies. Paul is passionate about advancing the field of eCOA and mobile health through research and active involvement in industry consortia. He previously served as Industry Vice-Director of the C-Path ePRO Consortium. Earlier in his career, Paul worked as a Research Psychologist at a child and adolescent mental health clinic in Dublin, Ireland. He later moved into the health consulting field with United BioSource Corporation, where he worked across health outcomes, health economics and health data capture groups. Prior to joining Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led the health outcomes team. He holds an MSc in Cognitive and Clinical Neuroscience.

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