Open access
Aug 2026
Applying the estimand framework to safety: aligning estimators with treatment effects in the presence of intercurrent events.
This paper provides practical guidance on applying the estimand framework from the ICH E9(R1) addendum to safety outcomes in phase III randomised trials conducted for regulatory submissions and describes how IEs influence the interpretation of treatment effects in safety assessment.
P. López-Romero, B. Crowe, Philip He et al.
· BMJ evidence-based medicine · 0 citations