Gender Differences in Research

Dr. Rogers is Associate Professor of Nursing and Public Health and Director, Occupational Health Nursing Program, School of Public Health, University of North Carolina at Chapel Hill. T he Food and Drug Administration (FDA) has issued "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" (1993), which sets forth FDA's expectations about inclusion of both genders in drug development research. Furthermore, this guideline revises the section "Women of Childbearing Potential" in the 1977 guideline entitled "General Considerations for the Clinical Evaluation of Drugs" that excluded women of childbearing potential from participation in early studies of drugs. Two major changes are addressed. First, FDA is withdrawing the restriction on the participation of women of childbearing potential in early clinical trials, including clinical pharmacology studies and early therapeutic studies. Second, FDA is formalizing expectations about inclusion of subjects of both genders in drug development; analyses of clinical data by gender; assessment of potential pharmacokinetic differences between genders; and, where appropriate, assessment of pharmacodynamic differences and