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Discontinuation from randomised treatment is a common intercurrent event in clinical trials. When the target estimand uses a treatment policy strategy to deal with this intercurrent event, data after cessation of treatment is relevant to estimate the estimand and all efforts should be made to collect such data. Missing data may nevertheless occur due to participants withdrawing from the study and...
In the past, many clinical trials have withdrawn subjects from the study when they prematurely stopped their randomised treatment and have therefore only collected ‘on‐treatment’ data. Thus, analyses addressing a treatment policy estimand have been restricted to imputing missing data under assumptions drawn from these data only. Many confirmatory trials are now continuing to collect data from subjects...
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