The Importance Of Advocating For Female Participation In Clinical Trials

- By Kristen Snipes, Director, Clinical Operations, Health Decisions

Is being female a pre-existing condition? In the world of clinical research that was once the prevailing notion. In the past, researchers excluded women from trials because they believed their fluctuating hormones might cause them to respond differently to treatments, complicating the trial design and study results. Since control is the goal in any clinical environment, an all-male cohort of patients made sense.  

For decades, drugs were approved without being tested on women or factoring in whether women would have different reactions or require different dosages than men. Well-meaning policies, such as this 1977 U.S. Food and Drug Administration (FDA) policy, previously recommended women of childbearing potential be excluded from Phase I and early Phase II drug trials due to fears about the effects of experimental drugs on unborn children. This was true even for drugs specifically targeting women. In one famous study of the interaction between alcohol and flibanserin – also known as ‘female Viagra’ – 23 of the 25 study participants were male. 

Attitudes around involving women in clinical trials have evolved significantly in the past 25 years as research emerged proving the importance of studying biologic, physical and behavioral differences between genders. However, despite new expectations from regulators pushing for women to be involved in studies, parity has yet to be achieved.