ISPOR Europe 2025
ISPOR Europe 2025, taking place between 9-12 November in Glasgow, Scotland, is a leading conference focused on advancing value and access in healthcare through patient-centered collaboration. The event will bring together global experts in health economics and outcomes research (HEOR), featuring presentations on innovative methodologies such as indirect treatment comparisons, real-world evidence studies, and causal inference techniques. Barbara Bakonyvári, Scientific Advisor, eCOA Science at Clario will present a poster on “Key risk indicators in eCOA – Considerations for improving eDiary data quality and regulatory compliance”. Be sure to pass by the poster area for the presentation and discussion period.
Session information:
Title: Key risk indicators in eCOA – Considerations for improving eDiary data quality and regulatory compliance
Date: Tuesday, November 11, 2025
Time: 10:30 – 13:30 BST
Discussion Period: 12:30 – 13:30 BST
Abstract:
The abstract discusses the importance of Key Risk Indicators (KRIs) in electronic Clinical Outcome Assessments (eCOAs), particularly electronic diaries (eDiaries), which are essential for capturing accurate patient-reported outcomes in clinical trials.
It highlights the challenges of data quality due to variability in patient adherence and reporting, and notes that regulatory agencies expect risk-based monitoring approaches.
The authors present considerations for developing effective KRIs, including metric definitions, detection of inconsistencies, and integration into monitoring strategies, using examples from ulcerative colitis and insomnia trials.
The structured process involves selecting metrics, setting thresholds, establishing feedback loops, and planning corrective actions, with a focus on protocol-specific customization.
The implementation of KRIs is shown to enhance data quality, regulatory compliance, and trial efficiency by enabling early detection of data issues and supporting timely decision-making.
Speaker
Barbara Bakonyvári, MA
Scientific Advisor, eCOA Science at Clario
Barbara Bakonyvári is a researcher psychologist with experience in clinical trial and clinical psychological social study data analysis, patient reported outcome (PRO) development and assessment validation (psychometric analysis). She currently works as a Scientific Advisor of eCOA Neuroscience and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on eCOA design/use, best practices for study protocol, custom site rater training, participant training and central monitoring from an academic perspective to drive achieving the highest scientific standards.