Author: Rod Rahimi, Solution Expert at CluePoints.
Risk assessment is the foundation of Risk Based Quality Management (RBQM). The adoption of statistics to assist with quality oversight is well documented, leading to the evolution of RBQM from a ‘nice-to-have’ into a ‘must-have’ in clinical trials.
However, there can be a temptation to jump straight into analytics. Before doing so, it is essential to understand why those metrics are so important and how we create them. I think of risk assessment as the dinner and the algorithms as the dessert.
To facilitate a complete end-to-end RBQM experience, study teams must understand the risk assessment process. Why is the data so important? How do we set up our metrics? What do we look for to have the most risk-averse clinical trials? How do we create trials focusing on patient safety and our primary objectives?
By setting up a robust risk assessment, you are setting yourself up for success. In addition, you are proactively finding ways to create a protocol that is risk-averse.
Risk assessment in RBQM
According to ICH E6(R2), gold standard RBQM should include seven steps: critical process and data identification, risk identification, risk evaluation, risk control, risk communication, risk review, and risk reporting.
Risk assessment is crucial to the first four steps. By completing a risk assessment, you are identifying your critical variables, you are identifying your risks, you are evaluating your risks, and you are setting controls for your risks.
RBQM is a dynamic and ongoing process that follows the entire lifecycle of a study. Risk control, risk communication, risk review, and risk reporting, i.e., the remaining steps of the ICH gold standard RBQM methods, will influence the multiple versions of a risk assessment that are produced as new risks spawn, and as you use your metrics to gather more information about the trial.
It is by completing the initial risk assessment, however, that you check off the first four items and follow Good Clinical Practice (GCP) requirements.
Risk assessment allows study teams to document their thinking about risks in their trial related to fulfilling RBQM and GCP requirements. Performing a risk assessment during the drafting process of a protocol is a way for teams to proactively consider critical variables and risks, and how to mitigate them before the trial begins. As the trial is in execution, those risks can then be mitigated, by adding specific language into functional plans or training documentation, for example, and monitored using metrics such as KRIs or QTLs. This is vital when looking at ways to focus on patient safety and primary and secondary endpoints.
A validated risk assessment system
CluePoints offers a validated risk assessment system. It gives users a complete audit trail with full workflow and version control. This allows the user to have multiple versions of a risk assessment within one validated system. It also offers the ability to report what is put into a risk assessment and create and leverage libraries of critical variables, risks, and mitigations. This means if a risk assessment is created for one trial and it is similar to another trial within the organization, the first assessment and its components can be leveraged in a second risk assessment.
Finally, a validated risk assessment system allows users to make the risk assessment independently with customized templates and libraries with the ability to configure risk and critical variables fields.
The future of Risk Assessment
ICH E8(R1) highlighted the importance of reviewing Critical to Quality Factors to determine whether adjustments to risk control mechanisms are needed. I envision this being embedded within the risk assessment process before the formal assessment takes place.
Whatever the future holds, it is clear risk assessment is vital to designing risk-adverse trials with patient safety at the forefront. While embracing the opportunities of RBQM, we must also learn to walk before we can run, ensuring study teams have a foundational knowledge of risk assessment and why it is so important to the clinical trial landscape.