Data and Knowledge Manager, CluePoints
Safety monitoring generates substantial signal volume across risk-based quality management tools, but only 30% to 36% of signals correspond to confirmed issues, suggesting the need for better prioritization, signal consolidation, and alignment between detection and proportional action.
Quality tolerance limits work best as a small set of focused guardrails that prompt rapid investigation and documented action, not as documentation exercises, with early breaches expected when sample sizes are small.
Sylviane de Viron, data and knowledge manager at CluePoints, shares new data highlighting regional variations in clinical trial risks—and how proactive risk planning based on up-to-date data is needed to overcome them.
Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk indicator signals close on similar timelines, durability—not speed—is the defining differentiator in effective, risk-based quality management.
To maximize the impact of signal detection, KRI frameworks should follow a few guiding principles.
Exploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.
Study uncovers insights on the impact on safety, patient enrollment/retention, and compliance.
The long-held practice is effective in pinpointing the emergence of known and unknown risks to clinical development, study shows.
Recent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.
A review of industry methods and adoption trends in those trial segments.
Analysis confirms there is a relatively high degree of variability in risk planning results across studies.
New data shows the adoption of studies introducing quality tolerance limits continues to surge—and offers clues on focus of implementation.
Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.
Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.
Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.
Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.
As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.
Industry sees high increase in the use of QTLs.
Study indentifies trends in most commonly used KRIs.
March 2nd 2023
