This panel discussion, hosted by C-Path’s Electronic Clinical Outcome Assessment Executive Director Scottie Kern, features experts from industry and academia; Bill Byrom, Principal of eCOA Science at Signant Health, Melissa Mooney, Director of eCOA Solution Engineering at IQVIA, Thomas Moll, Senior Scientific Advisor at Clario, and Devin Pipert, Professor of Health Outcomes Research and 125th Anniversary Chair at the University of Birmingham, UK.
The conversation explores the evolving role and strategic integration of clinical outcome assessments, particularly those administered electronically, in oncology research. The episode highlights historical context, regulatory insights, practical implementation challenges, and future directions for clinical outcome assessment use in oncology clinical trials.
Key insights:
- Oncology has increasingly recognized the importance of a clear assessment strategies, moving beyond a cursory use of patient-reported outcomes, which have been part of cancer trials since the 1990s.
- The use of Bring Your Own Device (BYOD) approaches is favored for frequent at-home patient reported data collection, accommodating patient convenience and reducing burden.
- Successful clinical outcome assessment solutions require not only high-quality data collection and compliance, but also effective feedback mechanisms for clinical sites, including dashboards, alerts, and reports to maintain engagement and improve patient experience.
- Patients generally do not find completing patient-reported outcomes burdensome if the data collected is meaningful and leads to tangible clinical benefit.
- The importance of long-term follow-up, especially for advanced therapies (e.g., cell and gene therapies) and rare cancers and diseases, necessitates integration of clinical outcome assessment data into routine clinical care beyond traditional trial settings.
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