Estimands for clinical endpoints in Tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial.

ABSTRACT:

Background

Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estimation methods complicates across-trial comparisons and hinders the advancement of treatment guidelines. The International Council for Harmonization (ICH) provides international regulatory standards for clinical trials. The estimand framework outlined in the recent ICH E9(R1) addendum offers a timely opportunity for randomized trials of TB treatment to adopt broadly standardized outcome definitions and analytic approaches. We previously proposed and defined four estimands for use in this context. Our objective was to evaluate how the use of these estimands and choice

SUBMITTER: Weir IR 

PROVIDER: S-EPMC10659528 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature