The Representation of Women in Clinical Drug Trials

Abstract

The representation of women in clinical trials has been a controversial and frequently debated issue in recent years. In response to evidence suggesting that sexually-biased practices exist in drug research, several policy changes aimed at redressing existing inequities have been initiated. The United States Food and Drug Administration (FDA) is currently revising its guideline regarding the enrollment of women in early phases of drug testing. It appears that the revised policy will permit women of child-bearing potential to be enrolled in clinical trials prior to the completion of animal reproductive toxicology studies. The National Institutes of Health (NIH) has revised its “Guide for Grants and Contracts” to call for a greater involvement of women in clinical trials. The NIH has also instituted a comprehensive study termed the Women's Health Initiative to examine major causes of morbidity and mortality among women. These initiatives and policy changes will affect the clinical research practices of the ...