Evaluation of treatment effect modification by biomarkers measured pre- and post-randomization in the presence of non-monotone missingness.

ABSTRACT: In vaccine studies, an important research question is to study effect modification of clinical treatment efficacy by intermediate biomarker-based principal strata. In settings where participants entering a trial may have prior exposure and therefore variable baseline biomarker values, clinical treatment efficacy may further depend jointly on a biomarker measured at baseline and measured at a fixed time after vaccination. This makes it important to conduct a bivariate effect modification analysis by both the intermediate biomarker-based principal strata and the baseline biomarker values. Existing research allows this assessment if the sampling of baseline and intermediate biomarkers follows a monotone pattern, i.e., if participants who have the biomarker measured post-randomization would al

SUBMITTER: Zhuang Y 

PROVIDER: S-EPMC9216643 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature