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464 – Missing Data
Estimand Choice and Handling of Treatment Switch in Randomized Clinical Trials
Ulker Aydemir
INC Research
In placebo-controlled clinical trials patients may switch to a rescue medication or to another treatment than the initial randomized treatment due to ethical reasons if pre-defined criteria for the switch are fulfilled. As a consequence patients are withdrawn at the timepoint of their switch from the study, i.e. before the planned assessment of the primary endpoint Various estimands and imputation approaches are discussed for the specific situation of a trial where patients self-control the intake and dose of rescue medication they need with regards to their disease symptoms.