Scholarlink

Background <p>The 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.</p> Objective <p>To 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.</p> Methods <p>We 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.</p> Results <p>Assessment 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.</p> Conclusions <p>Using 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.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 发表日期：

    2026年4月27日

查看全文
  • Takahiro Kuwahara,
  • Ryota Kidena,
  • Naoki Kato,
  • Rika Okamoto,
  • Naoko Hagimori,
  • Atsuhiko Kawamoto

摘要

Background

The 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.

Objective

To 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.

Methods

We 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.

Results

Assessment 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.

Conclusions

Using 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.