Including women in clinical trials isn’t enough Thirty years after women were formally brought into clinical research, inclusion has improved but important questions remain about how sex, pregnancy, and menopause affect drug safety and efficacy. Written byBree Foster, PhD

Including women in clinical trials isn’t enough Thirty years after women were formally brought into clinical research, inclusion has improved but important questions remain about how sex, pregnancy, and menopause affect drug safety and efficacy. Written byBree Foster, PhD https://www.drugdiscoverynews.com/including-women-in-clinical-trials-isn-t-enough-17547?utm_campaign=DDN_Newsletter_Dose&utm_medium=email&_hsenc=p2ANqtz-987umcgyZyybU1C6LRPXLrtpT14yVtKeK7Ii0Yq1kujW0McI7IV9FDTHmaQGuxd4Ie9niFifIvL8Tm3S9q0ODxBn7xBw&_hsmi=443497174&utm_content=443497174&utm_source=hs_email Despite making up almost half of the world’s population, women have historically been underrepresented in clinical studies. It was only in 1993 that the NIH Revitalization Act established that women and minorities had to be included in all NIH-funded clinical research. That same year, the FDA issued guidance encouraging the inclusion of women in clinical trials, including early-phase studies. This legacy of exclusion has left critical gaps in our understanding of how diseases and treatments affect women, with potential consequences for drug safety and efficacy.