Statistical data monitoring (SDM) plays a crucial role in maintaining the integrity and quality of clinical trial data. By employing various statistical tests on patient data across different study sites, SDM is designed to detect unusual data patterns that may indicate underlying systemic issues in how the trial is being conducted.
Impact of SDM on Clinical Trial Quality
Quantitative analyses of central monitoring's impact on clinical trial quality remain rare. A recent analysis explored the impact of SDM on improving quality metrics in clinical trials, comparing results to studies conducted without the use of central monitoring to assess its effectiveness. The analysis, published in Therapeutic Innovation & Regulatory Science, includes data collected from the CluePoints Central Monitoring platform between September 2015 and November 2024. It focuses on 2,044 atypical sites across 300 completed studies from a range of therapeutic areas and study phases. A site’s atypicality is assessed using the platform’s "Data Inconsistency Score" (DIS), where DIS scores above 1.3 indicate atypical behavior. For comparison, the same analysis was conducted on 43 atypical sites from two studies that did not use central monitoring.
Key Objectives and Findings
The primary objective was to determine the proportion of sites with improving quality, defined as a decrease in the DIS score after SDM intervention (DISC < DISO). The study found that 81% of sites demonstrated improvement in quality when SDM was applied, compared to only 56% of sites not using any central monitoring. This difference was statistically significant, highlighting the impact of SDM on improving site quality.
Another objective was to measure the extent of quality improvement by examining the relative change between the DISO and the DISC. On average, sites using SDM showed a 43% improvement in their quality scores. This improvement was consistent across different therapeutic areas and study phases. In contrast, sites not using central monitoring demonstrated a much smaller average improvement of only 17%, further emphasizing the effectiveness of SDM in driving quality enhancements.
Distribution of DIS Scores
The distribution of the DISO for sites using SDM and sites not using any central monitoring is quite similar. However, when examining the DISC, a stark contrast emerges. Sites using SDM show a much narrower distribution, with 61% of sites no longer considered atypical. In contrast, sites without central monitoring have a broader distribution, with 51% still deemed atypical at the end of the study. Furthermore, for many sites, the DISC was even higher than the DISO, indicating that issues left unaddressed early on tend to persist and even worsen in subsequent data snapshots. This highlights the value of SDM, as it enables the identification of emerging issues, allowing the study team to take corrective actions and adapt their approach, preventing the same problems from impacting future data collected during the trial.
Importance of Proactive Engagement
Sylviane de Viron, data and knowledge manager at CluePoints, and Steve Young, chief scientific officer, emphasize that the effectiveness of SDM depends on a study team that is not only ready to adopt SDM but also committed to investigating potential issues, taking appropriate corrective actions, and ensuring proper follow-up. It is this proactive and engaged approach that maximizes the impact of SDM in enhancing trial quality.
