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Early development (ED), first-in-human or small clinical trials (e.g. rare diseases) often have a complex and dynamic study design and are fast-paced. It can be challenging to find the appropriate balance in risk-based approaches and timing of implementation to assure value-added oversight.

Participant safety in first-in-human clinical trials is of utmost importance, which makes implementation of risk-based approaches challenging for the study teams and, therefore, often results in a conservative approach where everything is considered critical.

While trials that focus on rare diseases may not be fast-paced, they are challenging due to the limited data available to provide insights into emerging risks.