W-28: Main Difference between Quality Tolerance Limits and Key Risk Indicators

Poster Presenter

David Lacagnina

President
The Eclinical Agency
United States

Objectives

Define the main benefits of risk-based quality measurement using Quality Tolerance limits (QTLs) and Key Risk Indicators (KRIs).

Method

Application of quality control method was done on large oncological Phase III study. The project group has devoted a year to the evaluation and optimization of Risk-Based Quality Managemetn (RBQM) for the study.

Results

Number of Metrics: 29 Number of KRIs: 19 Number of QTLs: 5 Number of Identified Risk Escalations: 1,011 The majority of risk escalations happens on the Site and Country level and the number of root-elements is proportionally higher. The high number of escalations is associated either with too strict thresholds or with difficulties in the study. Thus, in the current study, the issues with enrollment, protocol deviations (PD) and queries take the first leading positions in the rating of risk escalations. On the site level, the risk escalations are not equally distributed, which gives a large potential for optimizations of monitoring activities and focusing on “troublemakers”. The focus on sites who collect dirty data and show high recruitment would also very positively influence the chance to reach statistical significance at the end of the study, as the sources of dirty data will be timely highlighted. Still, there is a large group of sites who were not really involved actively in the study. They have not yet captured data and cannot be assessed from the data quality perspective. Therefore, it is essential to continue monitoring of the study in order to assess the newly activated sites.

Conclusion

The main benefits of risk-based quality management are: Compliance with ICH GCP E6(R2). Failure to comply with ICH GCP E6(R2) could lead to a rejection of the study by authorities (FDA and/or EMA). Predictable Success of the Study. Delaying the study by 7 to 8 months will result in additional costs in the mid 7-digit range, especially if additional patients need to be enrolled in the study. Corporate Knowledge Management. Many lessons had already been learned by staff during the study pilot. This knowledge could be applied to the next study and within a short timeframe. Efficient Vendor Management. The number of manual queries in the study are in the magnitude of > 20.000, which is above and beyond the industry standard.