In 1977, the US Food and Drug Administration (FDA) excluded women of “childbearing potential” from participating in clinical research until adequate safety and efficacy information could be developed during animal and early clinical studies.
1 This exclusion, along with perceived challenges with recruiting women, subsequently resulted in the poor inclusion of women in clinical trials.
2,3 In addition, women have been historically regarded as suboptimal research participants because of their estrous cycle and inherent reproductive differences from men, although data exist to refute this assumption.
4,5 Because of the low enrollment of women in clinical trials, the National Institutes of Health (NIH) Revitalization Act was introduced and became a law on June 10, 1993. This law mandated the inclusion of women as participants in clinical research funded by the NIH. However, studies have shown that the inclusion of women in clinical trials has marginally improved.
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