Why we know so little about women’s health | University of Utah Health

Women were already poorly represented in medical research before the 1970s, but progress in researching drugs and medical devices in women was further set back in 1977, when the Food and Drug Administration (FDA) created a policy to exclude women of reproductive potential from Phase 1 and 2 clinical trials unless they had a life-threatening condition, according to the National Institutes of Health (NIH) Office of Research on Women’s Health. This was in reaction to a tragedy in the previous decade when a drug called thalidomide, which thousands of pregnant European and Australian women took for morning sickness, was found to cause severe birth defects — and sometimes death — for their babies. The drug had been tested and approved in Europe and Australia for its sedative effects, though it was never approved in the United States. Nevertheless, the FDA’s policy to exclude women of reproductive potential from most clinical trials was interpreted broadly, excluding nearly all premenopausal women, including those who were on birth control, had sterile partners, or abstained from sex.
It was not until nearly a decade later, in 1986, that the policy to exclude women from clinical research was revisited. And in 1993, the U.S. Congress passed a law requiring the inclusion of women in clinical research.
As recently as 2019, women accounted for roughly 40% of participants in clinical trials for three of the diseases that most affect women — cancer, cardiovascular disease, and psychiatric disorders — despite representing 51% of the U.S. population, according to a 2022 study by researchers at Harvard Medical School. Concerns also persist about the lack of information about medications and other interventions during pregnancy, since pregnant people are even more commonly excluded from trials.
The picture is even more bleak for women of color. The MRCT Center published an article in 2022 pointing out that often clinical trial data do not report the intersection of biological sex and race, and that some systematic reviews of clinical trials that report such information show significant underrepresentation of women of color.
“Given the number of people who are seen and [the amount of] products that are prescribed annually, we should be able to develop a better way of accessing real world data,” Bierer, one of the study authors, says. “For many reasons, people are now much more alert to the need to include different populations that have been historically underrepresented in clinical trials … both for social justice reasons and for the scientific insights we can glean, which we hope in time will reduce health disparities.”
That will require a rethinking of how researchers recruit and retain participants, says Danielle Mitchell, CEO and founder of Black Women in Clinical Research, an organization focused on furthering the inclusion of Black women working in the field.
Mitchell’s mission is to bridge the gap between Black communities and the clinical research field. She talks about clinical research at churches and hair salons. She hopes that the people leading clinical research will do their part by broadening their scope when it comes to hiring people at their research sites, from the receptionists to the coordinators to the principal investigators.
“When people go into [a] clinic, often times they don’t see anyone who looks like them,” Mitchell says, explaining that this creates missed opportunities to build trust and educate about clinical trials. “From my perspective, we need to have those tough conversations with people about what happened in the past for people to consider clinical trials as a health care option.”
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