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- Title
Between-group comparison of area under the curve in clinical trials with censored follow-up: Application to HIV therapeutic vaccines.
- Authors
Alexandre, Marie; Prague, Mélanie; Thiébaut, Rodolphe
- Abstract
In clinical trials, longitudinal data are commonly analyzed and compared between groups using a single summary statistic such as area under the outcome versus time curve (AUC). However, incomplete data, arising from censoring due to a limit of detection or missing data, can bias these analyses. In this article, we present a statistical test based on splines-based mixed-model accounting for both the censoring and missingness mechanisms in the AUC estimation. Inferential properties of the proposed method were evaluated and compared to ad hoc approaches and to a non-parametric method through a simulation study based on two-armed trial where trajectories and the proportion of missing data were varied. Simulation results highlight that our approach has significant advantages over the other methods. A real working example from two HIV therapeutic vaccine trials is presented to illustrate the applicability of our approach.
- Subjects
AIDS vaccines; CLINICAL trials; MISSING data (Statistics); VACCINE trials; DETECTION limit
- Publication
Statistical Methods in Medical Research, 2021, Vol 30, Issue 9, p2130
- ISSN
0962-2802
- Publication type
Article
- DOI
10.1177/09622802211023963