Table 3.

TransCelerate estimand template

Objective	Treatment policy estimand	Alternative 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 choice	Treatment: 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.