Estimation of Treatment Policy Estimands for Continuous Outcomes Using Off-Treatment Sequential Multiple Imputation.

ABSTRACT: The estimands framework outlined in ICH E9 (R1) describes the components needed to precisely define the effects to be estimated in clinical trials, which includes how post-baseline 'intercurrent' events (IEs) are to be handled. In late-stage clinical trials, it is common to handle IEs like 'treatment discontinuation' using the treatment policy strategy and target the treatment effect on outcomes regardless of treatment discontinuation. For continuous repeated measures, this type of effect is often estimated using all observed data before and after discontinuation using either a mixed model for repeated measures (MMRM) or multiple imputation (MI) to handle any missing data. In basic form, both these estimation methods ignore treatment discontinuation in the analysis and therefore may be bia

SUBMITTER: Drury T 

PROVIDER: S-EPMC11602932 | biostudies-literature | 2024 Nov-Dec

REPOSITORIES: biostudies-literature