EDITORIAL

Clinical trials

European Medicines Agency policies for clinical trials leave women unprotected

Maria Teresa Ruiz Cantero¹, Maria Angeles Pardo²

¹ Department of Public Health, University of Alicante, Alicante, Spain
² San Juan University Hospital, Alicante, Spain

Correspondence to:
Correspondence to:
M T R Cantero
Department of Public Health, University of Alicante, Apdo 99, 03080-Alicante, Spain; cantero@ua.es

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Relevance of equality of gender in clinical research

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The first 150 words of the full text of this article appear below.

Specific strategies to implement guidelines for the study and evaluation of gender differences in the clinical evaluation of drugs have not been developed by the European Medicines Agency (EMEA). This agency accepts "that some of the factors that influence the effect of a medicine in the population may be important when considering potential differences in response between men and women" and "gender-specific influences can also play a significant role in drug effect". But besides these statements, in a document about gender considerations in the conduct of clinical trials, the EMEA argues against the need for separate International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on women as a special population group, based on their internal review and experience, but without providing the sources.¹ The lack of sound fundaments of these convictions is worrisome. This paper analyses the document of EMEA,¹ . . . [Full text of this article]

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• Chilet-Rosell, E., Ruiz-Cantero, M. T., Horga, J. F. (2009). Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. J Public Health (Oxf) 31: 434-445 [Abstract] [Full Text]  
• Ruiz-Cantero, M. T., Vives-Cases, C., Artazcoz, L., Delgado, A., Garcia Calvente, M. d. M., Miqueo, C., Montero, I., Ortiz, R., Ronda, E., Ruiz, I., Valls, C. (2007). A framework to analyse gender bias in epidemiological research. J. Epidemiol. Community Health 61: ii46-ii53 [Abstract] [Full Text]