Women’s health and gender-based clinical trials on etoricoxib: methodological gender bias

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Title: Women’s health and gender-based clinical trials on etoricoxib: methodological gender bias
Authors: Chilet Rosell, Elisa | Ruiz-Cantero, María Teresa | Horga de la Parte, José Francisco
Research Group/s: Salud Pública
Center, Department or Service: Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia | Hospital General Universitario de Alicante. Unidad de Farmacología Clínica
Keywords: Clinical trials | Etoricoxib | Gender bias | Gender differences | Sex differences
Knowledge Area: Medicina Preventiva y Salud Pública
Date Created: 2009
Issue Date: 14-Mar-2009
Publisher: Oxford University Press
Citation: CHILET ROSELL, Elisa; RUIZ CANTERO, María Teresa; HORGA DE LA PARTE, José Francisco. "Women’s health and gender-based clinical trials on etoricoxib: methodological gender bias". Journal of Public Health. Advance Access published online on March 14, 2009. ISSN 1741-3842, pp. 1-12
Abstract: Background The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. Methods The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). Results Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors.
Sponsor: Health Research Fund of Carlos III Health Institute of the Spanish Ministry of Health and Consumption. Women’s Studies Center of the University of Alicante.
URI: http://hdl.handle.net/10045/10943
ISSN: 1741-3842 (Print) | 1741-3850 (Online)
DOI: 10.1093/pubmed/fdp024
Language: eng
Type: info:eu-repo/semantics/article
Rights: © The Author 2009, Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved
Peer Review: si
Publisher version: http://dx.doi.org/10.1093/pubmed/fdp024
Appears in Collections:INV - SP - Artículos de Revistas
Institucional - IUIEG - Publicaciones

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