Endpoints and estimands
Define objectives outcomes and effects
An estimand specifies the population, treatment conditions, outcome variable, handling of intercurrent events and population-level summary. An intercurrent event changes interpretation or existence of an outcome; it is not synonymous with a missing measurement.
Flow diagram
Steps
Study objectives
Identify the claims and questions for the study.
Primary endpoints
Specify one or more primary outcomes and success criteria.
Secondary endpoints
Define secondary priorities and confirmatory versus exploratory roles.
Safety endpoints
Define safety outcomes separately from trial-stopping decisions.
Define estimands
Define the population, treatment conditions, outcome variable, strategy for each intercurrent event and population-level summary. Distinguish intercurrent events from missing measurements.
Define assessments and missing data
Specify assessment timing and ascertainment after treatment changes. Separately define missing-outcome assumptions and methods compatible with the estimand.
Endpoints and estimands
End flow
Tables and supporting information
Endpoint register
Add rows for multiple primary or secondary endpoints.
Estimand register
Tie each estimand to a prespecified outcome.
Estimand rationale
Attach evidence supporting endpoints, event strategies and clinical interpretation.