Impact of monitoring approaches on data quality in clinical trials

AimsSource data verification (SDV) has been reported to account for up to 25% of the budget in clinical trials (CT) and cost-benefit of SDV has been questioned. Guidelines for risk-based monitoring (RBM) were published in 2013 by agencies and in 2016, ICH-GCP-E6-(R2) added a requirement for risk-based approaches. This report will perform a comparison of the impact of RBM vs classic monitoring (CM) on data quality (defined as accuracy of data reporting from source data to final trial data) and expected impact on costs of CTs. MethodsData on residual errors from four, large comparable randomised CTs were examined by post-trial SDV. Observed discrepancies were analysed in the categories of overall data, major efficacy and major safety. In each category, the residual error rate was calculated as the number of discrepancies divided by the number of data-fields verified. ResultsA total of 1 716 087 data points were verified using CM and 323 174 using RBM. The overall error rate was 0.40% for RBM and 0.37% for CM (P < 0.01). For major efficacy, defined by risk assessment, the error rate was 0.15% and 0.28% (P < 0.0001); in major safety, defined by risk assessment, the error rate was 0.49% and 0.67% (P = 0.15), both in favour of the RBM approach. ConclusionThese empirical data, directly comparing RBM with CM, suggest that RBM improves data quality regarding data-points of major importance to trial outcomes, efficacy and major safety. Overall, the RBM approach showed a correlation to reduced amount of data collection errors with major relevance for interpretation of study results and subject safety as well as reducing on-site monitoring and data cleaning resources.

Automated summary

This study compared the impact of risk-based monitoring (RBM) and classic monitoring (CM) on data quality in clinical trials (CTs) and analyzed the expected impact on CT costs. The results showed that RBM had lower error rates in major efficacy data and major safety data compared to CM, indicating that RBM improves the accuracy of trial results and subject safety.