What approach should the sponsor develop according to ICH E6 for monitoring clinical trials?

The appropriate approach for monitoring clinical trials, as outlined by ICH E6, is a systematic, prioritized, risk-based approach. This method is designed to ensure that monitoring efforts are focused on the areas of the trial that possess the highest risk of impacting participant safety and data integrity.

By adopting a risk-based approach, sponsors can identify and prioritize monitoring activities based on the potential risks associated with the clinical trial. This entails evaluating various factors such as the complexity of the study, the therapeutic area, and previous trial outcomes to tailor the monitoring plan accordingly. The emphasis is placed on ensuring that resources are allocated effectively to mitigate identified risks.

This approach allows for a more efficient use of time and resources while also enhancing the quality of the trial. Sponsors can proactively identify issues that could compromise the validity of the study or the safety of the participants, thereby fostering a robust and compliant clinical trial process.

In contrast, other approaches, such as a cost-based approach, may overlook essential risks and lead to inadequate monitoring, while a randomized approach may not provide enough structure or focus on risk prioritization. A subject-focused approach might limit the monitoring scope to individual participants without considering broader systemic risks that can affect the trial overall. Thus, a systematic, prioritized, risk-based approach is