Exclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness. But the drug caused serious birth defects, including missing or deformed limbs.
The resulting outcry helped prompt a 1977 Food and Drug Administration recommendation to exclude women of childbearing age from early-stage trials, stalling a push at the time to bring more women into scientific research.
