03/03/2026
In 1977, the FDA barred women of childbearing potential from most early-phase clinical trials. While the intent was to minimize risks to potential pregnancies, but the consequence was sweeping: women were excluded from research that would go on to define how diseases are diagnosed, how symptoms are interpreted, and how treatments are prescribed.
A 2022 systematic review in Women’s Health Reports confirmed what many clinicians now recognize — studies historically excluded female subjects, both human and animal, and treated male biology as the standard (Merone et al., 2022). This is the foundation our medical system was built on. Understanding this history not only explains the gaps in women’s healthcare, but also highlights why women today must ask more critical questions about their care—especially when it comes to hormonal health, cardiovascular risk, and life stages that were barely studied until recently.