Risk Planning: A Review of Industry Trends

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An essential component of risk-based quality management (RBQM), as detailed in both the ICH E8 (R1) and ICH E6 (R2) GCP guidelines, is to perform proactive assessments of risk starting with the initial design of a study, again during study planning, and as needed throughout study execution. Important risks identified at each stage should result in actions (“mitigations”) designed to minimize the likelihood or impact of those risks to patient safety and/or reliability of the study results.

A risk planning solution was released in December 2016 on the CluePoints RBQM platform and has been used extensively. In this article, we present a number of risk planning trends compiled from a selection of 250 studies representing 35 different research organizations. A summary of the results can be found in Figure 1.

The first step of risk planning involves the identification of processes and data that are considered critical to the quality of the study, also referred to as critical-to-quality factors. The median number of critical processes identified per study is 10, and the median number of data items is 17. There is a relatively high degree of variability around those medians, with, for example, 25% of the studies having less than seven critical processes and another 25% having more than 14 critical processes. Similarly, the interquartile range for critical data items is nine to 24.

The next step in the process is to identify all potential risks associated with the identified critical-to-quality processes and data. Our risk planning data reveal a median of 42 risks being identified per study, with, again, a relatively broad interquartile range of 33 to 62.

Once identified, each risk is then evaluated to determine its importance. This evaluation involves assigning a relative score to each of three dimensions of the risk—its likelihood of occurring, the impact it would have to patient safety and/or reliability of trial results, and the detectability of the risk during the study. A composite risk score is compiled from the three individual scores, which helps the study team to determine which are the most important risks to mitigate. In particular, thresholds are set to assign relative risk levels of high, medium, and low. Those risks are most likely to be mitigated. A median of 63% of all risks in a study are marked as high or medium.

The final step is to decide which risks should be mitigated, and to detail the mitigation actions to be taken for those risks. Our risk planning data show that a median of 67% of all risks in a study have been mitigated. Additionally, in most of the studies (91%) research organizations have decided to mitigate all of the medium and high risks.

This analysis confirms that there is a relatively high degree of variability in the risk planning results across studies, in terms of the total number of critical data, processes, and risks identified and evaluated. This should be expected, given the significant variability in the complexity of clinical trial designs and logistics. It is interesting to observe that 42 risks are identified per study, on average, and 67% of the risks are, on average. This translated to a general trend of approximately 28 mitigated risks per study. We will continue to monitor these risk planning trends and plan to present an update in the coming year.

Steve Young, Chief Scientific Officer, CluePoints; Sylviane de Viron, Data and Knowledge Manager, CluePoints