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Considerations of Sex and Gender Differences in Preclinical and Clinical Trials

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Sex and Gender Differences in Pharmacology

Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 214))

Abstract

Women continue to be underrepresented in clinical trials, particularly in Phases I and II of experimental drug studies in spite of legislative guidelines in the USA, Canada, the European Union, Australia, and Japan requiring the inclusion of women in clinical trials. As such, women remain a vulnerable population subject to the adverse effects of pharmacological therapies. Thus, women experience higher rates of adverse drug reactions than do men and for women of reproductive age or who may be pregnant, therapeutic options may be limited. This chapter provides a brief history of inclusion of sex and gender as variables in clinical trials, summarizes governmental legislation for consideration of sex and gender in clinical trials and provides specific examples of drugs which have been withdrawn from the market because of side effects in women. Additional information related to sex and gender in preclinical testing, trial design, challenges to recruitment of women for clinical trials and statistical methods for analysis of data also is considered.

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Authors and Affiliations

  1. Department of Physiology and Biomedical Engineering, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA

    Limor Raz PhD & Virginia M. Miller PhD

  2. Department of Surgery, Mayo Clinic, Rochester, MN, 55905, USA

    Virginia M. Miller PhD

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Correspondence to Virginia M. Miller PhD .

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Editors and Affiliations

  1. Institute of Gender in Medicine (GiM), Center for Cardiovascular Research (CCR), Charité - Universitätsmedizin Berlin, Hessische Str. 3-4, Berlin, 10115, Germany

    Vera Regitz-Zagrosek

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Raz, L., Miller, V.M. (2013). Considerations of Sex and Gender Differences in Preclinical and Clinical Trials. In: Regitz-Zagrosek, V. (eds) Sex and Gender Differences in Pharmacology. Handbook of Experimental Pharmacology, vol 214. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-30726-3_7

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