Electronic clinical outcome assessment (eCOA) has become an essential tool for capturing patient data, but one critical challenge continues to arise. Many eCOA platforms are developed with a technology-first mindset, building solutions that seem impressive on the surface, but fail to address real-world needs. Reversing this approach and tailoring eCOA to trials enables greater success and creates systems that benefit sponsors, site staff, and patients alike.
The pitfalls of putting technology first
A common approach has been to develop eCOA technology, then try to retrofit it into existing trial structures. This method often results in solutions that meet basic requirements but fail to adapt to the unique challenges of specific trial types or patient populations.
One-size-fits-all solutions and generic interfaces may not resonate with diverse patient groups, leading to poor compliance and high dropout rates. Additionally, when tools are not intuitive or user-friendly, the reliability and completeness of collected data can suffer. Complex or poorly designed systems can also increase the workload for site staff, potentially impacting trial efficiency.
A better approach is to start with the user experience and work backward. This ensures the development of technology that truly solves the problems trial sponsors, site staff, and patients have. Achieving this objective requires a fundamental shift in how eCOA solutions are conceived and developed.
Shifting to a trial-specific design philosophy
To address these challenges, Datacubed Health adopts a flexible, personalized approach to eCOA design.
This methodology involves:
- Starting with patient needs: Understanding the patient journey and designing solutions that address real-world challenges faced by trial participants
- Incorporating behavioral science: Leveraging insights from psychology and human behavior to create engaging and intuitive interfaces
- Adaptive design: Developing flexible platforms that can be customized for different therapeutic areas and patient populations
- Continuous feedback loops: Regularly gathering input from patients, site staff, and sponsors to refine and improve eCOA tools
Patient-centric eCOA in action
Several case studies demonstrate the value of a more tailored approach to eCOA.
Age-appropriate engagement in pediatric trials
In a global pediatric trial involving participants aged 6-16, Datacubed Health faced the challenge of maintaining engagement over time while accommodating participants who might age out of certain questionnaires.
The solution included:
- Age-appropriate questionnaires that automatically updated over time
- Gamification to maintain interest and motivation
- Support and guidance for both patients and caregivers
This approach demonstrates how eCOA can be tailored to meet the specific needs of younger participants, improving data quality and retention rates.
Revolutionizing frontotemporal dementia (FTD) research
Collaborating with the University of California, San Francisco, Datacubed Health developed a tool for remote data collection in FTD studies. This rare, early-onset form of dementia presents unique challenges due to its cognitive and behavioral symptoms.
Datacubed Health’s solution addressed:
- Reduced travel burden for patients
- More frequent data collection for improved accuracy
- Increased diversity in trial participation
- Sensitive measures to detect early-stage symptoms
A cycle-based approach for oncology trials
Recognizing the limitations of milestone-based eCOA in oncology trials, Datacubed Health developed a cycle-based approach.
This allows for:
- Customization to each patient’s unique disease progression
- Adaptability to changing treatment cycles
- Improved data collection relevant to the patient’s current status
By designing the eCOA solution around the realities of oncology treatment, researchers can gather more meaningful and accurate data.
Global adaptability
Understanding the importance of geographic and cultural considerations, Datacubed Health has invested in creating locally adapted versions of its platform. One example is their work in China, where they collaborated with authorities to develop a compliant application that can serve a potential patient pool of over a billion people.
The future of eCOA: Integration and innovation
As the clinical trial landscape evolves, the most effective eCOA solutions will likely be those that prioritize integration and innovative features tailored to patient needs. This extends not only to the trial types mentioned previously, but to any kind of clinical research.
The future success of eCOA in clinical trials depends on the industry’s ability to shift from a technology-first approach to one that prioritizes real-world needs. As Kyle Hogan, CEO of Datacubed Health, notes, “If you have a problem you’re looking to solve when it comes to data capture, it’s crucial to start with the patient experience.” This approach could increase patient engagement and ultimately lead to more efficient and effective research.
If you have a data capture problem, Datacubed Health has a personalized solution. Download the document below to learn more.
