Competing Risks: State the Probability Question Before the Model
When competing events occur, choosing between cumulative incidence and cause-specific hazard depends on the probability question and ICH E9(R1) estimand strategy.
15 minBy
Category
Estimands & Statistics
Estimands, intercurrent events, missing data, multiplicity, and analysis choices.
Time-to-Event Endpoints: Writing Censoring Rules Readers Can Follow
How clinical trial teams write executable censoring rules for time-to-event endpoints, aligning situation tables with ICH E9(R1) estimands and ADaM datasets.
31 minBy
PharmaDossier: Mapping Coverage Gaps to Trial Treatment Interruptions
A structured clinical trial guide for documenting therapy identity, supply responsibility, and actual exposure when routine-care or background regimens encounter insurance coverage delays before biostatisticians classify an intercurrent event.
20 minBy
Statistical Analysis Plans for Endpoints: What Must Be Locked Before Unblinding
A methodological guide for biostatistics and clinical development teams on what endpoint definitions, estimand-aligned estimators, and sensitivity analyses the SAP must lock before unblinding.
21 minBy
ICH E9(R1) Estimands: Specifying Intercurrent Events Before Endpoint Collection
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.
10 minBy
Missing Data vs Intercurrent Events: Estimand-Aligned Sensitivity Analysis
A methodological guide for biostatisticians and clinical trialists to separate intercurrent events from true missing data and pre-specify same-estimand sensitivity analyses.
9 minBy
Multiple Endpoints in Clinical Trials: Hierarchy, Co-Primaries, and Error Control
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.
9 minBy
