Process for Aggregate Assessment of Clinical Trial AE Data

The FDA’s 2021 draft update to the ‘Final Rule’ strongly supports aggregate assessment of clinical trial AE data, but provides little guidance on the best processes to use at different stages of development.

• With a clear process that defines approaches to the differing challenges of AE assessment in early development compared with Phase III, the overall end-user experience for internal and external stakeholders would be improved.
• When related preferred terms are grouped together, it would be beneficial to have a consistent process for analysis plan documentation, SDTM/ADaM specifications, and analysis displays.