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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 to emerging risks.