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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. BURZYKOWSKI, Tomasz LEGRAND, Catherine BUYSE, Marc |
Issue Date: | 2014 | Publisher: | WILEY-BLACKWELL | Source: | 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. | Keywords: | multicenter clinical trial; statistical monitoring; error detection; contamination rate; signal-to-noise ratio; linear mixed-effects model;multicenter clinical trial; statistical monitoring; error detection; contamination rate; signal-to-noise ratio; linear mixed-effects model | Document URI: | http://hdl.handle.net/1942/18128 | ISSN: | 0277-6715 | e-ISSN: | 1097-0258 | DOI: | 10.1002/sim.6294 | ISI #: | 000346055000005 | Rights: | Copyright © 2014 John Wiley & Sons, Ltd. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2016 |
Appears in Collections: | Research publications |
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