Published: 13 November 2021
Author(s): Federica Fogacci, Davide Gori, Arrigo F.G. Cicero
Issue: March 2022

Even though today there is recognition of the need to proportionally include in clinical trials and prospectively evaluate women and racial minorities through all phases of drug development, in previous decades the consideration and inclusion of men of Caucasian race overshadowed women and racial/ethnic minorities in clinical research design and conduct [1]. To counter this disparity, the US Food and Drug Administration (FDA) has implemented since 1993 guidelines encouraging greater participation of women and the need for diverse demographic enrolment [2].

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