Table 3

TransCelerate estimand template

ObjectiveTreatment policy estimandAlternative hypothetical estimand
Primary
The primary objective of the study is to compare overall survival of subjects treated with experimental therapy relative to those treated with protocol-specific physician’s choiceTreatment: Experimental/Placebo+Experimental on progression at discretion of local investigator
Population: ‘Advanced cancer’
Variable: Time to death
Population summary level: HR
Post Randomisation Event
  • Treatment switching for patients who progress in the control group, to be handled using a treatment policy strategy

Treatment: Experimental/Placebo
Population: ‘Advanced cancer’
Variable: Time to death
Population summary level: HR
Post Randomisation Event
  • Treatment switching for patients who progress in the control group to be handled by a hypothetical strategy (ie, the treatment effect if participants did not switch to experimental after progression)

  • HR, hazard ratio.