Linear Categorical Marginal Modeling of solicited symptoms in vaccine clinical trials

Bergsma, W. P., Aris, E. M. D. and Tibaldi, F. S. (2013) Linear Categorical Marginal Modeling of solicited symptoms in vaccine clinical trials. Statistics in Biopharmaceutical Research, 5 (1). pp. 27-37. ISSN 1946-6315

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Abstract

Analysis of the occurrence of adverse events, and in particular of solicited symptoms, following vaccination is often needed for the safety and benefit-risk evaluation of any candidate vaccine, and typically involves taking repeated measurements. In this article, it is shown that Linear Categorical Marginal Models (LCMMs) are well suited to take into account the dependencies in the data arising from the repeated measurements and provide detailed and useful information for comparing safety profiles of different products while remaining relatively easy to interpret. LCMMs are presented and applied to a Phase III clinical trial of a candidate meningococcal pediatric vaccine.

Item Type:	Article
Official URL:	http://www.tandfonline.com/loi/usbr20
Additional Information:	© 2013 American Statistical Association Statistics in Biopharmaceutical Research
Divisions:	Statistics
Subjects:	H Social Sciences > HA Statistics R Medicine > RS Pharmacy and materia medica
Date Deposited:	16 Mar 2015 10:07
Last Modified:	06 Jan 2024 20:03
URI:	http://eprints.lse.ac.uk/id/eprint/61227

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