Since the 1990’s Governments and Non-Governmental Organizations around the world have implemented policies requiring health research, protocols, and innovations to either include female persons or provide reasonable justification for their exclusion, however, the impact on health equity has not been as significant as hoped (NIH, 2024).
With the associated costs for controlling for the variability in female sex hormones as well as the added burden for participants in research, technologies and health protocols have for the most part, to this day, continued to measure females as a percentage of the Reference Man, a 70kg 20-30 year old white male, despite increased “inclusion” (Müller et al., 2022). As a result, health inequities through a growing sex and gender data gap continue to perpetuate.
Today, many researchers (both publicly and privately funded) still control for sex and gender variability in their studies citing either the “complexity” of including more accurate data collection and analysis, or the “adequacy” of the male proxy we’ve previously discussed (Bruinvels et al., 2017).
For those who do account for hormonal variability and sex as a biological variable there are several ways by which that data can be collected from serial blood measures to regular ultrasounds to the three step method (Janse de Jong, 2019 ). The current industry standard for monitoring hormone variability in eumenorrheic populations is the three step method which involves 90 days of calendar tracking, salivary swabs and urinary luteinizing hormone test sticks (Bouchard et al., 2023). Although this method is less burdensome than some of the others mentioned, it still comes with a considerable logistical, financial, and participant burden. Additional population constraints are added to this standard in order to produce consistent results such as: requiring participants to be off hormonal birth control, between the ages of 18 and 35, not within a year of giving birth or breastfeeding, within a preordained weight classification, and unimpacted by other reproductive or hormonal health issues (ex. endometriosis, polycystic ovary syndrome (PCOS)).
Consequently, researchers often either forgo capturing hormonal variability metrics, exclude the aforementioned “problem populations” which make up the majority of the female population (Bull et al., 2019), or struggle to recruit and retain participants which often leads to small sample sizes, and difficulty in capturing consistent quality data. As a result, it becomes challenging to be able to generalize results to a broader population to make meaningful claims about the impacts of sex and female reproductive hormones as biological variables even if the data is collected. Due to this gap in the research process, there are still many populations who don’t have accurate or representative information available to inform their diagnostic or treatment process —this is what creates the 1 Trillion dollar women’s health gap (Ellingrud et al., 2024).
In order for scientific research in the health and life sciences to move forward in a way that is equitable across sex and gender, we must make it easier for innovators and researchers to include and accurately represent sex and gender differences at scale.
Join us on June 4th as we discuss the “Future of Data Equity” and dig into how My Normative helps researchers more easily account for sex and gender based differences. Register today!
Want to get started today? Book a meeting with Allison.
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Citations:
Bouchard, Thomas et al. “Establishing a Gold Standard for Quantitative Menstrual Cycle Monitoring.” Medicina (Kaunas, Lithuania) vol. 59,9 1513. 23 Aug. 2023
Bruinvels G, Burden RJ, McGregor AJ, et al. Sport, exercise and the menstrual cycle: where is the research? Br J Sports Med. 2017; 51(6):487-488.
Bull, J.R., Rowland, S.P., Scherwitzl, E.B. et al. Real-world menstrual cycle characteristics of more than 600,000 menstrual cycles. npj Digit. Med. 2, 83 (2019).
Ellingrud, K et al. “Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies.” 17 January 2024.
Müller MJ, Bosy-Westphal A, Braun W, Wong MC, Shepherd JA, Heymsfield SB. What Is a 2021 Reference Body? Nutrients. 2022; 14(7):1526.
National Institute of Health (NIH). NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Accessed 11 April 2024.
