Considerations of sex and gender differences in preclinical and clinical trials

Research output: Chapter in Book/Report/Conference proceedingChapter

18 Scopus citations

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for consideration of sex and gender in clinical trials and provides specific examples of drugs which have been withdrawn from the market because of side effects in women.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.

Original languageEnglish (US)
Title of host publicationSex and Gender Differences in Pharmacology
EditorsVera Regitz-Zagrosek
Pages127-147
Number of pages21
DOIs
StatePublished - Nov 8 2012

Publication series

NameHandbook of Experimental Pharmacology
Volume214
ISSN (Print)0171-2004
ISSN (Electronic)1865-0325

Keywords

  • Animal studies
  • Cultured cells
  • Definitions
  • Legislation
  • Phase I
  • Phase II
  • Phase III
  • Statistical analysis

ASJC Scopus subject areas

  • Biochemistry
  • Pharmacology, Toxicology and Pharmaceutics(all)

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