Supporting Women's Health: Addressing Gender Disparities In Clinical Trials

According to the Nation Institute of Health’s Office of Research on Women’s Health, in 1977 the FDA recommended the exclusion of pregnant women and women of ‘childbearing potential’, regardless of contraception, from Phase I and Phase II clinical trials. This ensued after incidents occurred in Canada and throughout the EU of children being born with physical deformities as a result of pregnant women who had taken drugs with little known research on the effects.  

This recommendation perpetuated a preexisting gender gap in clinical trial demographics in the United States which limited the study and understanding of drug interactions and therapeutics to male participants. This inevitably led to an extreme shortage of data on women’s health as it related to new forms of therapies and drug treatments leaving large question marks in women’s health as a whole.