Enhancing the Clinical Trial Risk Assessment Process

Project Scope 

We propose beginning this project by identifying CtQ factors via a risk assessment process (characterising risk including assessment and mitigation/risk reduction strategies), which would include identifying trial-level QTLs that support CtQ factors. 

Conducting a risk assessment for a clinical trial (a pre-competitive set of activities) can be time-intensive and may not be consistently focused on relevant critical to quality (CtQ) risks. Defining and recommending enhanced approaches and best practices may help increase the effectiveness and efficiency of this critical activity. Refining the risk assessment process (to include identifying CtQs and how they align with intercurrent events/estimands (ICEs) and the application of quality tolerance limits (QTLs)) can help ensure the scientific question is answered and the data collected is reliable and interpretable for the planned analysis. 

Increased stakeholder support and participation. More meaningful risk assessments. Ability to re-use information collected in processes downstream from risk assessment, to enhance effectiveness and efficiency.