Snapshot:
- Adoption of eCOA: The use of electronic clinical outcome assessments (eCOA) has increased, with sponsors expecting ePROs to make up 53% of COAs collected in the next two years.
- Implementation Challenges: Sponsors report frustrations with traditional eCOA implementations related to build, deployment, and integration with other eClinical technologies.
- Enhancing Patient Usability: Focus on user experience, design, and device compatibility is essential for improving patient usability of eCOA solutions, ultimately driving data accuracy and a better trial experience.
Enhancing ease of outcome reporting and data accuracy
As the clinical trial industry has adopted electronic clinical outcomes assessment (eCOA) methods over the last 20 years, we have been able to improve patient questionnaire compliance, to minimize transcription errors between paper and electronic systems, and to reduce time spent inputting data and aligning across paper and electronic platforms.1 eCOA is now firmly embedded within the clinical trial landscape, with sponsors reporting in the Industry Standard Research (ISR) that they have used eCOA in 53% of their trials over the last two years, and plan to use eCOA in 64% of trials over the next two years.2
Within this growth, there is a noticeable shift toward prioritizing patient-reported outcomes (PROs). Sponsors expect ePROs to make up 53% of the COAs collected in the next two years, compared to 45% over the last two years, which emphasizes an increasing value placed on patients’ voice and experience.
Use of eCOA in current and future trials
Source: Industry Standard Research. “eCOA/ePRO Benchmarking and Market Dynamics (5th Ed.).” September, 2023.
Although eCOA is widely adopted, it is also a technology tool that can cause frustrations during implementation. In conversations with sponsors, we have heard that traditional eCOA solutions can be challenging due to issues with build and deployment, implementation, and usability.
Common challenges in eCOA implementations
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Specifically, integrations are an issue that often comes up for sponsors. In a Suvoda LinkedIn poll, 39% of respondents said eClinical integrations are their biggest challenge in eCOA implementations.
Greatest challenges in eCOA implementations
Source: Suvoda. “What Are the Biggest Challenges in eCOA Implementations?” February, 2024.
ISR’s research found similar trends, with 47% of sponsors identifying improved integrations with eClinical technologies as an area for traditional eCOA improvement.3
Areas for desired eCOA improvements
Source: Industry Standard Research. “eCOA/ePRO Benchmarking and Market Dynamics (5th Ed.).” September, 2023.
Notably, 37% of sponsors identified patient usability as another opportunity for improvement in eCOA solutions.4 RWS Life Sciences, an expert in usability testing, identifies several characteristics of eCOA solutions that drive patient usability, including the user experience, design, and device.5
A framework for patient usability of eCOA solutions
User Experience |
Design |
Device |
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eCOA has been and will continue to be an important tool within the clinical trial industry. As we continue to develop powerful, unified, and easy to use solutions, we can strengthen data accuracy and drive increasing effectiveness in clinical outcome assessments collection. Just as important, this can improve the patient experience during trials while maintaining data integrity, leading to enhanced clinical trial efficiency and reliability.
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Resources
1“What Is Electronic Clinical Outcomes Assessment (ECOA) for Clinical Trials?,” Suvoda, November 20, 2023, https://www.suvoda.com/insights/blog/electronicclinical-outcomes-assessment-ecoa
2 eCOA/ePRO Benchmarking and Market Dynamics (5th Ed.) (ISR Reports, September 27, 2023), https://research.isrreports.com/reportaction/2023-ecoa-eprobenchmarking-market-dynamics/Marketing
3 eCOA/ePRO Benchmarking and Market Dynamics (5th Ed.) (ISR Reports, September 27, 2023), https://research.isrreports.com/reportaction/2023-ecoa-eprobenchmarking-market-dynamics/Marketing
4 eCOA/ePRO Benchmarking and Market Dynamics (5th Ed.) (ISR Reports, September 27, 2023), https://research.isrreports.com/reportaction/2023-ecoa-eprobenchmarking- market-dynamics/Marketing
5 “Suvoda ECOA Earns High Marks in Patient Usability Study,” Suvoda, November, 2023, https://www.suvoda.com/insights/all-news/suvoda-ecoa-earns-high-marksin- patient-usability-study