Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical Trials.

backgroundThe introduction of Quality Management Systems and Risk-Based Approaches (RBA) in clinical trials has been promoted. In RBA risk assessment, Risk Priority Numbers (RPNs), similar to Failure Mode and Effects Analysis (FMEA), are widely used. However, as FMEA has issues with consistency and reliability between assessors, there are similar concerns with RBA.

objectiveTo address the issues of consistency and reliability of risk assessment in clinical trials, we developed a novel risk assessment scale (TRI scale) and investigated its effectiveness.

methodsWe developed the TRI scale by defining the Severity, Occurrence Frequency, and Detectability of risk events in clinical trials, which are components for RPN calculation. We compared assessment results using the TRI scale with those using conventional risk assessment scales in three occupational groups. We created a predefined list of potential causal factors for risk events and incorporated it into the process, allowing each evaluator to select relevant factors from the list. We compared the selection trends of these causal factors among the three groups.

resultsAssessment scores were higher using the TRI scale than the conventional assessment scale. Variance in scores among occupational groups increased after TRI scale introduction. The tendency to select causal factors differed depending on the occupational group.

conclusionsUsing specific criteria, the TRI scale suppresses variability caused by conventional subjective evaluation and reduces uncertainty in the assessment process; it may therefore be a useful decision-support tool for RBA in clinical trials.