Table 1.

Estimand-to-Analysis Table Template

Objective: Study objective (clinical question of interest) as written in the trial protocol
Estimand: Succinctly describes the estimand attributes outlined in more detail below
Treatment: Treatments or interventions of interest
ESTIMAND	ANALYSIS
Target population	Analysis set
Population targeted by the clinical question of interest	Participants within the clinical trial contributing to estimation of the population-level summary measure b
Variable	Outcome measure
Measure obtained for each individual required to address the clinical question of interest	How the variable will be determined for analysis
Handling of intercurrent events	Handling of missing data
Intercurrent Event 1 (Strategya) Intercurrent Event 2 (Strategya) (Repeat for each intercurrent event)	Imputation approach for missing data and underlying assumptions Sensitivity analyses: Different ways of handling missing data
Population-level summary measure	Analysis approach
Summary measure for the variable that serves as a basis for treatment effect, without the treatment or for comparison between treatments	How the statistic (estimator) will be calculated Sensitivity analyses: Different assumptions/methods for calculating the estimator

^aStrategies defined in E9 (R1) include Treatment Policy, While on Treatment, Composite, Principal Stratum, and Hypothetical

^bIf there are multiple analysis groups (e.g. comparison groups in multi-arm trials), the groups can be defined here.