Risk-Based Monitoring: A Strategic Approach to Enhancing Data Quality in Clinical Trials (Motivated by the Comparative Study of Monitoring Methods in Phase 2–3 Trials by Andersen et al.)

As clinical trials become increasingly complex and resource-intensive, traditional monitoring approaches—characterized by exhaustive source data verification and uniform site visits—have come under scrutiny for their inefficiency and limited added value. Risk-based monitoring has emerged as a promising alternative that emphasizes the strategic allocation of oversight resources based on the potential impact of specific data points and processes on trial outcomes and participant safety. This report examines risk-based monitoring as a structured, data-driven methodology, motivated by a comparative analysis of four large, multicenter trials conducted by Andersen et al. In this analysis, one trial employed a risk-based strategy while three used conventional monitoring. Post-trial error assessments revealed that risk-based monitoring achieved equal or lower error rates in data categories of major importance—such as primary efficacy and safety—while significantly reducing oversight in lower-risk areas. The report includes representative tables and visualizations to illustrate performance differences and operational efficiencies between approaches. It further explores the required dataset characteristics, the importance of targeted verification, and future directions for enhancing monitoring precision through emerging technologies. Collectively, these findings underscore the value of risk-based monitoring as a modern best practice for improving clinical trial data quality while optimizing cost and resource allocation.