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© A-M. Pais-Correia, M-I. Thoulouze, A. Alcover, A. Gessain
Mise en évidence de structures de type "biofilm ", formées par le rétrovirus HTLV-1 générés par des cellules infectées (cellules du haut), qui ont été transmis à un autre lymphocyte (cellule du bas). Micrographie en microscopie électronique à balayage. Image colorisée.
Publication : Statistical methods in medical research

Between-group comparison of area under the curve in clinical trials with censored follow-up: Application to HIV therapeutic vaccines.

Scientific Fields
Diseases
Organisms
Applications
Technique

Published in Statistical methods in medical research - 01 Sep 2021

Alexandre M, Prague M, Thiébaut R,

Link to Pubmed [PMID] – 34218746

Link to DOI – 10.1177/09622802211023963

Stat Methods Med Res 2021 Sep; 30(9): 2130-2147

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.

https://pubmed.ncbi.nlm.nih.gov/34218746