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Linear mixed-effects models for central statistical monitoring of multicenter clinical trials.

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Desmet, Lieven [UCL] Venet, D Doffagne, E Timmermans, Catherine [UCL] Burzykowski, T Legrand, Catherine [UCL] Buyse, M

Multicenter studies are widely used to meet accrual targets in clinical trials. Clinical data monitoring is required to ensure the quality and validity of the data gathered across centers. One approach to this end is central statistical monitoring, which aims at detecting atypical patterns in the data by means of statistical methods. In this context, we consider the simple case of a continuous variable, and we propose a detection procedure based on a linear mixed-effects model to detect location differences between each center and all other centers. We describe the performance of the procedure as a function of contamination rate and signal-to-noise ratio. We investigate the effect of center size and variance structure and illustrate the use of the procedure using data from two multicenter clinical trials. Copyright © 2014 John Wiley & Sons, Ltd.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2014
Language Anglais
Journal information "Statistics in Medicine" - Vol. 33, no. 30, p. 5265-5279 (2014)
Peer reviewed yes
Publisher JohnWiley & Sons Ltd. (Chichester)
issn 0277-6715
e-issn 1097-0258
Publication status Publié
Affiliation UCL - SSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles
Keywords multicenter clinical trial ; statistical monitoring ; error detection ; contamination rate ; signal-to-noise ratio ; linear mixed-effects model
Links
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Bibliographic reference Desmet, Lieven ; Venet, D ; Doffagne, E ; Timmermans, Catherine ; Burzykowski, T ; et. al. Linear mixed-effects models for central statistical monitoring of multicenter clinical trials.. In: Statistics in Medicine, Vol. 33, no. 30, p. 5265-5279 (2014)
Permanent URL http://hdl.handle.net/2078.1/154231