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Perspective

The Underrepresentation of Women in Clinical Trials

Faith Sinnott1

1 University of Missouri

As a woman navigating my early twenties, ensuring my health and safety has become a top priority. As I delved deeper into this topic, it became more and more apparent that this prioritization is one-sided; it is a common theme in the feminine space to feel misguided in healthcare. Whether it’s your friend who has a mysterious and chronic stomach ailment or your sister with debilitating menstrual cramps, women are too often written off, misdiagnosed, or not diagnosed at all. While doing my research, I found a comically abysmal statistic; there is five times as much research conducted on erectile dysfunction, which affects 19% of men, than research conducted on premenstrual syndrome (PMS) which affects 90% of women.1 Need I state the importance of research? Every medication, treatment, protocol, surgery, etc. is perfectly manufactured for the male body, with little to no idea of how it could harmfully impact the female body.2 For a problem of such magnitude, why is there such little emphasis placed upon it? 

 

     Most of the information we have gathered on the human body through research is based upon on male participants.2 Even though males and females are biologically similar, there are differences in symptomatology and physiological processes. Consequently, results from the male participants can provide insight into how interventions may impact the female body, but they remain far from precise. Although women make up 51% of the population, it wasn’t until 1993 that Congress passed a law (The NIH Revitalization Act of 1993) requiring the inclusion of women in NIH-sponsored clinical trials.2 Prior to the law’s passage, women were not allowed to participate in clinical trials due to the belief that female hormones would skew the results of the drug per a 1977 FDA ruling (excluding women without a life-threatening condition).2 While it is an important step in achieving gender equality in NIH-sponsored studies, a substantial portion of research comes from private organizations, many of which are focused on primarily researching men’s health. This is partly due to the fact that those overseeing funding decisions are often men, and they tend to give preference to funding research on diseases which primarily affect men or both men and women instead of female-specific conditions.  

 

     Women are excluded and under-enrolled in clinical trials for a number of reasons. Those with children must navigate the added challenge of arranging childcare to be able to participate in the trial, a responsibility that many men don’t face to the same extent. In addition, for the pharmaceutical and research industry, there are more financial and legal risks involved with enrolling women due to the risk of pregnancy. For example, the FDA generally recommends testing chemicals on non-human animals first to assess the substance for reproductive toxicity.2 While some researchers may overlook this critical step to save time and reduce costs, doing so adds an extra layer of uncertainty and harm for any female participants who enroll in trials. This lack of certainty, coupled with the notion that the industry does not trust women to not get pregnant, depresses female enrollment rate in clinical trials. One might ask: does this pose any threat to the integrity of the trial, or potentially jeopardize the research team’s standing with the NIH? The answer is no. As long as the researchers communicate that they put an effort into recruiting women and that not enough women qualified for the trial, they pass every inspection. 3

 

     Generally, a great amount of importance is placed on women with childbearing capabilities/those who are fertile. The fear of fertility complications (i.e, female participants becoming pregnant) is yet another excuse to exclude women from research that we so desperately need. This is due to an incident that occurred in the 1960s, in a trial for a drug used to treat morning sickness; thalidomide was administered to pregnant women in Europe and Australia, and it was found to have caused severe birth defects and infant deaths (the canon event for the 1977 FDA ruling).2 This incident introduced newfound reluctance towards trialing premenopausal women altogether; unfortunately, this reluctance overlooks key biological differences between the bodies of women who differ in age, as premenopausal and postmenopausal women have varying processes and should not be considered comparable. For example, postmenopausal women regardless of age tend to have lower bone density and a higher risk of cardiovascular issues. Both of these factors could significantly impact the female body’s response to the proposed drug.2 In the words of Martha Gulati, MD, a cardiologist at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, “It’s important to study women to find out how to care for 51% of the population. We are the majority of the population. Although women are special, we are not a ‘special population.’”2 It is not often that the majority gets minority treatment, but all efforts shall not be derailed. Many people may be unaware of this issue, but with greater recognition, meaningful progress can be made to bridge these inequalities. In order to forge progress, researchers need to be held accountable, funding for female-specific research must be increased, the significance of equity in research must be emphasized, and systemic attitudes must be transformed to drive lasting change.

Works Cited

  1. Slawson, Nicola. “‘Women Have Been Woefully Neglected’: Does Medical Science Have a Gender Problem?” The Guardian, Guardian News and Media, 18 Dec. 2019, www.theguardian.com/education/2019/dec/18/women-have-been-woefully-neglected-does-medical-science-have-a-gender-problem

  2. Balch, Bridget, et al. “Why We Know so Little about Women’s Health.” AAMC, AAMC, 26 Mar. 2024, www.aamc.org/news/why-we-know-so-little-about-women-s-health.

  3. Fultinavičiūtė, Urtė. “Sex and Science: Underrepresentation of Women in Early-Stage Clinical Trials.” Clinical Trials Arena, 17 Oct. 2022, www.clinicaltrialsarena.com/features/underrepresentation-women-early-stage-clinical-trials/.

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