The Exclusion of Women from Clinical Trials: A Historical Perspective
The 1977 FDA Guidelines: Protecting Potential Pregnancies at the Cost of Women's Health
In 1977, the U.S. Food and Drug Administration (FDA) issued guidelines that effectively excluded women of childbearing potential from early-phase clinical trials. The rationale behind this decision was to protect potential pregnancies and unborn children from the potentially harmful effects of experimental drugs. However, this well-intentioned policy had far-reaching consequences for women's health research.
Source: Merkatz, R. B., et al. (1993). Women in Clinical Trials of New Drugs -- A Change in Food and Drug Administration Policy. New England Journal of Medicine, 329(4), 292-296.
The 1993 Reversal: Inclusion of Women in Clinical Trials
It wasn't until 1993 that the FDA reversed its stance, requiring the inclusion of women in clinical trials. This change came about due to mounting pressure from women's health advocates and recognition of the significant gaps in medical knowledge regarding women's health.
Source: U.S. Food and Drug Administration. (1993). Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs.
The Slow Progress: Women's Representation in Clinical Trials as of 2018
Despite the policy change in 1993, progress has been slow. A 2018 study revealed that only 56% of clinical trials included women. This underrepresentation continues to have significant implications for women's health care.
Source: Scott, P. E., et al. (2018). Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. Journal of the American College of Cardiology, 71(18), 1960-1969.
The Impact: Why Women Struggle to Be Heard in Healthcare Settings
The historical exclusion of women from clinical trials has led to a significant knowledge gap in understanding how various medications and treatments affect women differently from men. This lack of information can make it challenging for healthcare providers to accurately diagnose and treat women, especially when it comes to conditions affected by hormonal changes.
To address these disparities, there's a pressing need for more inclusive clinical trials that adequately represent women across all stages of life. This includes considering hormonal fluctuations due to menstrual cycles, pregnancy, and menopause in study designs.
The historical exclusion of women from clinical trials has had lasting impacts on women's health care. While progress has been made, there's still a long way to go to ensure that medical research adequately represents and addresses women's unique health needs.
