Current practice on covariate adjustment and stratified analysis -based on survey results by ASA oncology estimand working group conditional and marginal effect task force.

ABSTRACT:

Background

The 2023 FDA's guidance on covariate adjustment encourages the judicious use of baseline covariates to enhance efficiency. However, when performing covariate adjustment in non-linear models, care must be taken on preserving estimation of the target estimand as introduced by the ICH E9(R1) addendum. To understand the current practices of covariate adjustment within the context of the estimands framework across various sectors and associated challenges, the conditional and marginal effect task force within the ASA Oncology Estimand working group conducted a survey.

Methods

The target participants of the survey were biostatisticians who support study designs and analyses in clinical trials in the drug development industry or in academia. A total of 19 questions were

SUBMITTER: Wei J 

PROVIDER: S-EPMC12584542 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature