Women and Clinical Trials

Traditionally, women are underrepresented in clinical trials. Larger gender gaps limit how much we know about the differences between men and women, including their reactions to certain treatments and medication. According to the Institute of Medicine, every cell in our body has a sex, which means that treating different conditions and diseases may have different effects depending on the gender of the patient.

Historically, women have been excluded from clinical trials since minorities and women were not included in government-funded health research until 1993; this is when the National Institutes of Health created a new mandate for the inclusion of women and minorities. In a recent effort to combat the ongoing gender gap issue, the NIH further provided $10 million to include more women in studies and in 2016 decreed that all studies had to include sex as part of the equation.

A perfect example of why involving women in clinical trials is so important is illustrated when one looks at the depression statistics. There are major endocrine changes that a woman goes through during the course of her life, including puberty, pregnancy, and menopause; all of which have been directly linked to depression. Twice as many women will be diagnosed with depression in their life when compared to men. When women are excluded from clinical trials, researchers are missing out on important information that could be learned about the metabolism rate of women, especially during the various changes that females go through.

Another example is shown with Alzheimer’s disease. Over two-thirds of the 5.1 million people in the USA suffering from Alzheimer’s are women. Research shows that not only is this the case because women live longer, but it also shows that the impact of hormonal changes at menopause and sex differences in gene expression may be involved as well.

Governing bodies, like the NIH, are now mandating the inclusion of women in clinical trials and studies. These changes have also led to the formation of many women’s health programs at government agencies which also advocate for change and inclusion. Continuing the dialogue, creating marketing campaigns that are female-targeted, encouraging the inclusion of females, and advocating for women’s health are all steps towards a fair and scientifically accurate medical and drug research system.

References
[1] https://www.theguardian.com/lifeandstyle/2015/apr/30/fda-clinical-trials-gender-gap-epa-nih-institute-of-medicine-cardiovascular-disease
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4478054/
[3] https://www.alzheimers.net/8-12-15-why-is-alzheimers-more-likely-in-women/
[4] https://www.nytimes.com/2014/09/23/health/23gender.html