In a recent LinkedIn Live session, Derk Arts, CEO of Castor, and eCOA expert Lisa Charlton explored a provocative question: Has the evolution of eCOA from simple data collection to complex patient engagement platforms actually made things worse?
The Early Days: Simplicity That Worked
Remember the beeping Palm Pilots? While technologically primitive, these single-purpose devices achieved something remarkable – they got the job done. With compliance rates driven by persistent audible reminders and a locked-down, focused interface, these early eCOA solutions delivered reliable data collection without the complexity we see today.
“Those early devices were very good at driving compliance because of the audible aspect… it was very challenging to ignore,” noted Charlton. “The concept of symptom-based collection of ePRO at home was much simpler because what we could accommodate was just focused around the assessment and the assessment alone.”
The Complexity Trap
Modern eCOA platforms have evolved far beyond their original purpose. What started as straightforward assessment tools have morphed into comprehensive patient engagement platforms incorporating eConsent, televisits, scheduling, and more. This expansion has introduced new challenges:
- Implementation Complexity
- Multiple decision points increase risk and deployment time
- Additional design documentation requirements
- Growing translation needs
- Complex UAT processes
- Data Quality Concerns
- Review screens presenting summarized responses for all questions prior to submission, and the impact of measurement properties or intended use of the validated assessment
- Retrospective diary capabilities compromising real-time data integrity
- Paper backup systems undermining the digital-first approach
- Site Burden
- Increased responsibility for technical support
- Managing multiple platforms and interfaces
- Navigation between various features and functions
The BYOD Dilemma
While Bring Your Own Device (BYOD) represents the future of eCOA, its implementation has revealed new challenges. “We’ve interpreted some guidances in manners that have increased the complexity of the solution design,” Charlton explained. The assumption that smartphone familiarity equals successful implementation has proven overly simplistic.
Path Forward: Engineering Elegance in Complexity
As Charlton emphasized, legacy eCOA solutions cannot support today’s complex trial designs and decentralized workflows. Modern trials demand sophisticated yet seamless solutions. The discussion revealed three key areas where complexity meets elegant design:
- Intelligent Support Architecture
- Shift from site-managed to direct vendor-patient technical engagement
- Create clear boundaries between technical and clinical workflows
- Deploy AI strategically to automate complex background processes while maintaining simple user interactions
- Invisible Integration
- Embed trial activities within patients’ existing digital ecosystems rather than adding new layers
- Design interaction patterns that feel native to modern technology use
- Handle complex protocol requirements behind intuitive user interfaces
- Allow flexibility between web, app, and potential voice interfaces based on patient preference
- Scientific Innovation
- Leverage real-world evidence to validate flexible approaches like BYOD in complex trial settings
- Pioneer new data collection methods that match natural behaviors while maintaining scientific rigor
- Reimagine traditional assessments for modern trial designs without compromising validity
- Balance methodological requirements with participant experience
Strategic Implementation Priorities
To achieve elegant solutions for complex trials, several critical areas require immediate focus:
- Scale Management
- Rethinking the economics of assessment licensing for modern trial designs
- Developing dynamic libraries that adapt to protocol complexity
- Creating scalable implementation frameworks for varied trial designs
- Decentralized Trial Architecture
- Building adaptive solutions that flex between site-based and remote settings
- Automating complexity management to reduce site and participant burden
- Designing unified data capture systems that work across all trial touchpoints
- AI-Enhanced Operations
- Deploying AI to manage complex backend processes while maintaining simple frontends
- Building regulatory-compliant automation frameworks
- Creating human-AI partnerships that optimize trial execution
The Future State
Tomorrow’s eCOA platforms won’t just manage complexity – they’ll make it invisible. This means creating well-integrated solutions that participants barely notice they’re using dedicated clinical trial technology.
“A trial participant answering their PRO should be as natural as picking up their kid from school,” Arts noted. “It’s just another thing you do as part of your daily life.”
Conclusion
The eCOA industry isn’t just at a crossroads – it’s at the frontier of redefining how we handle clinical trial complexity. Rather than choosing between capability and usability, the path forward lies in sophisticated solutions that make the complex feel simple. Success will come from platforms that can handle increasingly complex trial designs while delivering experiences that feel natural to both participants and sites.
Watch the full conversation between Derk and Lisa to dive deeper into these insights and join the discussion about the future of eCOA. Access the on-demand replay here.