Enhancing the Clinical Trial Risk Assessment Process

Project Description  

This project will begin by identifying critical to quality (CtQ) factors through a structured risk assessment process, including risk characterisation, evaluation, and mitigation strategies, alongside defining trial-level quality tolerance limits (QTLs) aligned with these CtQs. 

Risk assessment in clinical trials is often time-intensive and may not consistently prioritise the most relevant CtQ risks. Establishing enhanced approaches and best practices can improve both the efficiency and the effectiveness of this process. Refining the methodology to better integrate CtQs with intercurrent events/estimands (ICEs), and to clearly define QTLs, will help ensure the scientific objectives are met and that collected data is reliable and suitable for analysis. 

This approach is expected to strengthen stakeholder engagement, enable more focused and meaningful risk assessments, and support the reuse of risk assessment outputs in downstream activities, and improve overall study efficiency.