Process for Aggregate Assessment of Clinical Trial AE Data
Project Description |
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This project addresses the need for clear, practical processes for aggregate assessment of adverse event (AE) data during early clinical development, as encouraged by the FDA’s 2021 draft update to the Final Rule, which provides limited methodological guidance. The initiative will define approaches for AE assessment across development stages, recognising differences between early-phase studies and Phase III. It will establish consistent practices for grouping related preferred terms and align processes across analysis plans, SDTM/ADaM specifications, and output displays. The project will identify key challenges in detecting safety signals, evaluate appropriate analytical methods, and clarify important concepts such as “significance” in a clinical (non-statistical) context. It will also address limitations such as small sample sizes and uncertain background rates. Additionally, industry practices will be assessed through targeted surveys. The outputs will support more consistent, transparent and effective safety evaluations for both internal stakeholders and regulators. |
Project Leads | Emails |
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Mac Gordon, Johnson & Johnson | |
Peg Fletcher, MedAssessment | |
Nicola Newton, PHUSE Project Coordinator |
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