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http://hdl.handle.net/1942/18128
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DC Field | Value | Language |
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dc.contributor.author | Desmet, L. | - |
dc.contributor.author | Venet, D. | - |
dc.contributor.author | Doffagne, E. | - |
dc.contributor.author | Timmermans, C. | - |
dc.contributor.author | BURZYKOWSKI, Tomasz | - |
dc.contributor.author | LEGRAND, Catherine | - |
dc.contributor.author | BUYSE, Marc | - |
dc.date.accessioned | 2015-01-19T11:47:36Z | - |
dc.date.available | 2015-01-19T11:47:36Z | - |
dc.date.issued | 2014 | - |
dc.identifier.citation | STATISTICS IN MEDICINE, 33 (30), p. 5265-5279 | - |
dc.identifier.issn | 0277-6715 | - |
dc.identifier.uri | http://hdl.handle.net/1942/18128 | - |
dc.description.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. | - |
dc.description.sponsorship | The authors gratefully acknowledge financial support from the Walloon Government under the BioWin framework (consortium agreement no. 6741). The authors would also like to thank Bernadette Govaerts and Christian Ritter from Universite Catholique de Louvain for insightful discussions and the reviewers for making suggestions that significantly improved the paper. This research (Catherine Legrand and Tomasz Burzykowski) is supported by the IAP Research Network P7/06 of the Belgian State (Belgian Science Policy). | - |
dc.language.iso | en | - |
dc.publisher | WILEY-BLACKWELL | - |
dc.rights | Copyright © 2014 John Wiley & Sons, Ltd. | - |
dc.subject.other | multicenter clinical trial; statistical monitoring; error detection; contamination rate; signal-to-noise ratio; linear mixed-effects model | - |
dc.subject.other | multicenter clinical trial; statistical monitoring; error detection; contamination rate; signal-to-noise ratio; linear mixed-effects model | - |
dc.title | Linear mixed-effects models for central statistical monitoring of multicenter clinical trials | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 5279 | - |
dc.identifier.issue | 30 | - |
dc.identifier.spage | 5265 | - |
dc.identifier.volume | 33 | - |
local.format.pages | 15 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.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. | - |
local.publisher.place | HOBOKEN | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1002/sim.6294 | - |
dc.identifier.isi | 000346055000005 | - |
item.fulltext | With Fulltext | - |
item.fullcitation | Desmet, L.; Venet, D.; Doffagne, E.; Timmermans, C.; BURZYKOWSKI, Tomasz; LEGRAND, Catherine & BUYSE, Marc (2014) Linear mixed-effects models for central statistical monitoring of multicenter clinical trials. In: STATISTICS IN MEDICINE, 33 (30), p. 5265-5279. | - |
item.contributor | Desmet, L. | - |
item.contributor | Venet, D. | - |
item.contributor | Doffagne, E. | - |
item.contributor | Timmermans, C. | - |
item.contributor | BURZYKOWSKI, Tomasz | - |
item.contributor | LEGRAND, Catherine | - |
item.contributor | BUYSE, Marc | - |
item.accessRights | Restricted Access | - |
item.validation | ecoom 2016 | - |
crisitem.journal.issn | 0277-6715 | - |
crisitem.journal.eissn | 1097-0258 | - |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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desmet.pdf Restricted Access | Published version | 1.25 MB | Adobe PDF | View/Open Request a copy |
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