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Ulker Aydemir

INC Research



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464 – Missing Data

Estimand Choice and Handling of Treatment Switch in Randomized Clinical Trials

Sponsor: Biometrics Section
Keywords: Withdrawal, rescue medication, missing values, estimand, multiple imputation

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 As a consequence patients are withdrawn at the timepoint of their switch from the study, i.e. before the planned assessment of the primary endpoint Various estimands and imputation approaches are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.

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