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Efficacy vs Effectiveness — SCE Medical Oncology MCQ

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HardClinical Trials & StatisticsEfficacy vs EffectivenessSCE Medical Oncology

A randomised oncology trial specifies that 12-month quality of life will be compared according to randomised treatment regardless of permanent treatment discontinuation or subsequent therapy; outcomes continue to be collected after both events. Which ICH E9(R1) intercurrent-event strategy defines this estimand?

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Reveal the answer and explanation

Correct answer: B — Treatment-policy strategy

Explanation lettering: D = shown as C · C = shown as D

B is correct because outcomes are used regardless of discontinuation or subsequent therapy. A would incorporate the event into the endpoint; C would stop the outcome window at the event; D would target a world in which the event did not occur; E would target a subgroup defined by potential intercurrent-event behaviour.

Reference: ICH E9(R1) estimands training material (Current ICH training material): https://database.ich.org/sites/default/files/E9%28R1%29%20Training%20Material%20-%20PDF_0.pdf