By Dr Kavita Singh, Continental Lead Asia and South Asia Director, DNDi
Clinical research is the foundation of modern medicine, shaping the safety and efficacy of drugs. But for decades women — particularly those of childbearing potential — are routinely excluded from clinical trials.
Fewer than 30% of participants in industry-sponsored early-phase trials are women, an exclusion shaped by fears of legal liability, and perpetuated by a medical culture that assumes men’s bodies are the default for drug testing. The roots of this bias trace back to 1962, when the thalidomide tragedy led to a blanket ban by the Food and Drug Administration (FDA) in 1977 on including women of childbearing age in early-phase clinical trials. The intent was protection; the effect was systematic neglect. Even after the ban was lifted in 1993, the legacy of exclusion remained entrenched. Today, pharmaceutical companies and clinicians continue to sideline women in trials, citing concerns about pregnancy risks and hormonal fluctuations.
