The journal of clinical outcome assessment operations
Category
Estimands, intercurrent events, missing data, multiplicity, and analysis choices.
A methodological guide for clinical development and biostatistics teams to construct ICH E9(R1) estimands, specify intercurrent event strategies, and avoid common missing-data pitfalls.
A methodological guide for biostatisticians and clinical trialists to separate intercurrent events from true missing data and pre-specify same-estimand sensitivity analyses.
A rigorous analysis of multiplicity management in clinical trials, comparing FDA's 2022 final guidance and EMA's 2002 Points to consider across co-primaries, hierarchies, and gatekeeping.
