Women want to participate in clinical trials. Lack of flexibility is still a problem.

BioPharma Dive April 8, 2024
Kelly Bilodeau

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

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.

However, scientists found that excluding women from early drug tests came with its own set of consequences, including limiting...

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