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http://hdl.handle.net/1942/24156
Title: | Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials | Authors: | Desmet, Lieven Venet, David Doffagne, Erik Timmermans, Catherine LEGRAND, Catherine BURZYKOWSKI, Tomasz BUYSE, Marc |
Issue Date: | 2017 | Publisher: | AMER STATISTICAL ASSOC | Source: | STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 9(1), p. 1-11 | Abstract: | As part of central statistical monitoring of multicenter clinical trial data, we propose a procedure based on the beta-binomial distribution for the detection of centers with atypical values for the probability of some event. The procedure makes no assumptions about the typical event proportion and uses the event counts from all centers to derive a reference model. The procedure is shown through simulations to have high sensitivity and high specificity if the contamination rate is small and the atypical event proportions are the result of some systematic shift in the underlying data-generating mechanism. | Notes: | [Desmet, Lieven; Timmermans, Catherine; Legrand, Catherine] Catholic Univ Louvain, ISBA, Louvain La Neuve, Belgium. [Venet, David] Univ Libre Bruxelles, IRIDIA, Brussels, Belgium. [Venet, David] Univ Libre Bruxelles, Inst Bordet, Breast Canc Translat Res Lab, Brussels, Belgium. [Doffagne, Erik] CluePoints SA, Louvain La Neuve, Belgium. [Timmermans, Catherine] Univ Liege, Dept Math, Liege, Belgium. [Burzykowski, Tomasz] IDDI, Louvain La Neuve, Belgium. [Burzykowski, Tomasz; Buyse, Marc] Hasselt Univ, I BioStat, Hasselt, Belgium. [Buyse, Marc] IDDI, Biostat, San Francisco, CA USA. | Keywords: | Beta-binomial; Central statistical monitoring; Error detection; Multicenter clinical trial;beta-binomial; central statistical monitoring; error detection; multicenter clinical trial | Document URI: | http://hdl.handle.net/1942/24156 | ISSN: | 1946-6315 | e-ISSN: | 1946-6315 | DOI: | 10.1080/19466315.2016.1164751 | ISI #: | 000397258400001 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2018 |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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Desmet_et_al_Betabin.pdf | Peer-reviewed author version | 16.57 MB | Adobe PDF | View/Open |
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