When it comes to trials, gender is no biggie

JOURNAL TALK


There is a common myth that the subjects in clinical trials are mainly males — particularly white adult males — and that this may have concerning consequences in terms of a drug’s safety and efficacy once it reaches the diversity of the real world.

These concerns about the underrepresentation of women have been around for some time. In 1993, the US Food and Drug Administration reversed its post-thalidomide ban on the participation of childbearing-age women in early phase clinical trials, and the US Congress mandated that

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