THE ILLUSION OF COMPLIANCE: WHY ECOA-ONLY MONITORING FALLS SHORT IN DETECTING AND ADDRESSING DATA GAPS
Author(s)
Lindsay Hughes, PhD1, Christy Hoey2, Erik Degelman, BS3;
1IQVIA, Parsippany, NJ, USA, 2IQVIA, Scientific Manager, Durham, NC, USA, 3IQVIA, Pittsburgh, PA, USA
1IQVIA, Parsippany, NJ, USA, 2IQVIA, Scientific Manager, Durham, NC, USA, 3IQVIA, Pittsburgh, PA, USA
OBJECTIVES: Compliance monitoring in clinical trials often relies solely on electronic Clinical Outcome Assessment (eCOA) platforms; yet these represent only one component of a broader evidence ecosystem that includes Electronic Data Capture (EDC), laboratory systems, and Interactive Response Technology (IRT). Evaluating compliance in isolation can mask incongruencies, risking endpoint reliability, data completeness, and regulatory review. These gaps may remain undetected until database lock, compromising trial integrity.
This study aims to evaluate the limitations of eCOA-only compliance monitoring and identify cross-system data discrepancies across five studies spanning oncology (n=2), vaccines (n=1), autoimmune (n=1), and gastroenterology (n=1).
METHODS: Aligned datasets from eCOA, EDC, IRT, and other platforms were reviewed. Discrepancies included visit date mismatches (>1 day), missing assessments (scheduled but absent in one or more system), timing misalignments (outside protocol visit windows), and operational inconsistencies (e.g., dosing occurring after eCOA-assessment when same-day required). Metrics were calculated per 100 subject visits and impact assessed via endpoint missingness. Data were sourced from the IQVIA Patient Centered Solutions - Implementation (PCSI) monitoring activities.
RESULTS: Cross-system alignment revealed discrepancies invisible in eCOA alone: 5-15% of visits showed date mismatches; 8-15% of assessments were recorded in eCOA but absent in EDC; 8-11% of assessments that were marked as on time in eCOA violated the protocol-specified windows when matched to EDC dates. Lab data exposed delayed sample collections contradicting eCOA visit timing. Additional granular analyses will be discussed in presentation of this abstract, if accepted.
CONCLUSIONS: Findings demonstrate that eCOA-only monitoring can materially overestimate compliance. Integrated, cross-system monitoring enables detection of gaps earlier, strengthens endpoint validity, and aligns with regulatory expectations for comprehensive oversight.
This study aims to evaluate the limitations of eCOA-only compliance monitoring and identify cross-system data discrepancies across five studies spanning oncology (n=2), vaccines (n=1), autoimmune (n=1), and gastroenterology (n=1).
METHODS: Aligned datasets from eCOA, EDC, IRT, and other platforms were reviewed. Discrepancies included visit date mismatches (>1 day), missing assessments (scheduled but absent in one or more system), timing misalignments (outside protocol visit windows), and operational inconsistencies (e.g., dosing occurring after eCOA-assessment when same-day required). Metrics were calculated per 100 subject visits and impact assessed via endpoint missingness. Data were sourced from the IQVIA Patient Centered Solutions - Implementation (PCSI) monitoring activities.
RESULTS: Cross-system alignment revealed discrepancies invisible in eCOA alone: 5-15% of visits showed date mismatches; 8-15% of assessments were recorded in eCOA but absent in EDC; 8-11% of assessments that were marked as on time in eCOA violated the protocol-specified windows when matched to EDC dates. Lab data exposed delayed sample collections contradicting eCOA visit timing. Additional granular analyses will be discussed in presentation of this abstract, if accepted.
CONCLUSIONS: Findings demonstrate that eCOA-only monitoring can materially overestimate compliance. Integrated, cross-system monitoring enables detection of gaps earlier, strengthens endpoint validity, and aligns with regulatory expectations for comprehensive oversight.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO58
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Gastrointestinal Disorders, SDC: Oncology, SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain), STA: Multiple/Other Specialized Treatments, STA: Vaccines