Electronic COAs were meant to protect data quality and capture the patient voice. But missing baseline data, poor site preparation, and unrealistic timelines continue to break studies. In a frank discussion hosted by Castor, Derk Arts (Castor), Katja Rudell (Kielo Research), and Ari Gnanasakthy (RTI Health Solutions) unpacked where the breakdowns really happen — and how to address them practically.
“When you have 40% missing at baseline, you pretty much lost the study.” Ari Gnanasakthy
What Goes Wrong, Repeatedly in eCOA Clinical Trials
For over 20 years, eCOA has been positioned as a fix for data quality in clinical trials. But under pressure to launch quickly, the fundamentals still fail. Platforms aren’t validated in time. Sites are unprepared to train patients. Devices get stuck in customs. Sponsors overload studies with endpoints without checking whether sites can realistically execute them.
Ari gave a stark example: nearly half of baseline data lost because provisioned devices didn’t arrive on time. That kind of problem can destroy confidence in the entire trial, yet it keeps happening because sponsors focus on checklists rather than operational readiness.
“Defaulting to ePRO is fine. But when execution fails, confidence collapses.”
eCOA Organizational Friction and Clinical Operations
Many of these issues have little to do with the technology itself. They are organizational. Procurement departments pick eCOA vendors without involving scientific leadership. Clinical teams don’t leave enough time between protocol sign-off and first-patient-in. Multiple business units push conflicting priorities: commercial, HTA, regulatory, patient engagement — all pulling studies in different directions.
Katja noted even well-designed eCOA systems collapse when no one is coordinating translations, site training, device shipments, and ongoing data monitoring. When those hand-offs fail, secondary endpoints suffer, leaving massive data gaps no statistician can fix after the fact.
“Different teams chase different goals. That’s how data gets lost.” Katja Rudell
Practical Steps to Simplify eCOA Implementation
Derk challenged the group to question the myth of unavoidable complexity. In industries like aviation, change and surprises are planned for systematically. Clinical trials tolerate known failure points again and again — customs delays, missing devices, untrained staff — and act surprised every time.
The panelists pointed to several actionable ways forward:
- Fewer, higher-impact questionnaires
- Clearer and simpler language
- Repeated participant training, not one-time sessions
- Early, proactive data checks
- Backup strategies for BYOD if provisioned devices fail
Sponsors should also push vendors for true contingency planning. There is no excuse for having no Plan B in a study with critical endpoints.
“We act surprised every time these issues happen. That’s on us.” Derk Arts
A Path to Consistency and Patient-Reported Outcomes Success
No one suggested eCOA is fundamentally flawed. Quite the opposite: when done well, it supports high-quality patient-reported outcomes that add enormous value to a study. Ari reminded the audience that many trials do succeed — but those that fail, fail for predictable, preventable reasons.
Sponsors, CROs, and vendors should share lessons across studies, build repeatable playbooks, and train site staff continuously. Patients will only deliver quality data if their participation is practical and realistic — no matter what the protocol says on paper.
“If you expose patients to a product, you owe it to them to ask how they feel about it.” Katja Rudell
Key Takeaways
- eCOA failures are mostly organizational, not purely technical
- Missing baseline data is still a major, fixable risk
- Simplify questionnaires and instructions for patients
- Prioritize realistic site training and support
- Plan BYOD or hybrid fallback strategies early
- Review data continuously, not just at lock
Watch the full webinar on-demand here for unfiltered, practical insights you can apply to your next clinical trial.
