Document Server@UHasselt >
Research >
Research publications >

Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/18128

Title: Linear mixed-effects models for central statistical monitoring of multicenter clinical trials
Authors: Desmet, L.
Venet, D.
Doffagne, E.
Timmermans, C.
LEGRAND, Catherine
Issue Date: 2014
Citation: STATISTICS IN MEDICINE, 33 (30), p. 5265-5279
Abstract: 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 (c) 2014 John Wiley & Sons, Ltd.
Notes: [Desmet, L.; Legrand, C.] Catholic Univ Louvain, Inst Stat Biostat & Sci Actuarielles ISBA, B-1348 Louvain, Belgium. [Venet, D.] Univ Libre Bruxelles, IRIDIA, Brussels, Belgium. [Doffagne, E.; Timmermans, C.; Burzykowski, T.] Int Drug Dev Inst IDDI SA, Louvain, Belgium. [Burzykowski, T.; Buyse, M.] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat I BioSt, Diepenbeek, Belgium. [Buyse, M.] Int Drug Dev Inst IDDI Inc, San Francisco, CA USA.
URI: http://hdl.handle.net/1942/18128
DOI: 10.1002/sim.6294
ISI #: 000346055000005
ISSN: 0277-6715
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

Files in This Item:

Description SizeFormat
published version1.25 MBAdobe PDF

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.