Tuesday, Sep 21, 2021

Prioritizing women in scientific and clinical research

Gretchen Purcell Jackson, MD, PhD, FACS, FACMI, FAMIAVP, Scientific Medical Officer Digital, Intuitive

HLTH Foundation

Women, including people who are assigned female at birth1 and those identifying as women, are underrepresented in scientific and clinical research, with profound consequences. 

Biological females have anatomic, physiologic and genetic characteristics that affect their health. For example, they are more likely than biological males to develop osteoporosis due to hormonal changes, to injure their knees when playing sports due to the bone structure of their hips and knees, and after puberty, to experience depression for a variety of reasons.2 Emerging evidence also suggests that gender, which is associated with social constructs and differs from biological sex, also significantly influences health outcomes.3,4

One critical component of advancing health equity is to consider the role of women in the clinical research ecosystem. When women are underrepresented in clinical research – as study participants, clinicians, scientists and leaders – and when sex and gender are not explicitly considered in scientific studies, gaps in medical knowledge and ultimately poorer outcomes result. The industry must continue to use data and technologies and make systematic changes to help address this problem.

Enabling more women to participate in clinical trials

Women have faced several barriers when it comes to participating in clinical trials. A US Food and Drug Administration (FDA) 1977 guideline excluded biological females with childbearing potential from participation in phase I and II clinical trials of drugs until evidence of reproductive toxicity was available.5 The FDA did not reverse this restriction until 1993, which led to lasting effects and severe consequences. 

One review of sex differences in pharmacokinetics in FDA-approved drugs found that, for most drugs, biological females had elevated blood concentrations and longer elimination times than biological males, which were not explained by differences in weight. These findings may account for more frequent adverse drug reactions among females, as medications typically have standard dosing for adults or may be prescribed by weight, but rarely account for sex-based differences in metabolism or elimination.6 Efforts to enroll more females in clinical trials have been slow to yield increases, with the consequence being “sex inequality that hides in plain sight.”7

There are signs of progress; representation of females in pivotal clinical trials for novel drug approvals, including sex-specific indications such as post-menopausal or post-partum conditions, has increased from 40% in 2015 to 72% in 2019.8 However, very few studies examine or fully characterize gender as a variable. Scientific publications often mistakenly use the terms sex and gender interchangeably, creating additional gaps and confusion, and leaving room for improvement in the science. 

To make further progress, the industry must continue to improve access to clinical trials. Data and technology can help. Can decentralized trial technology improve access for participation of females in decentralized trials? Can real-world data help organizations uncover insights about the full patient experience with medications, including sex and gender differences in treatment preferences and response? Moving forward will require using data and technology to surface insights for meaningful action.

Empowering women to conduct and lead research

Another way to increase focus on sex and gender issues in clinical research is to have greater representation within research and leadership teams. It is estimated that less than 30% of the world’s researchers are women.9 

For decades, men have been known to publish more than women across scientific fields. One study found that, while women publish just as many papers as men year-to-year, women tend to have shorter careers.10 Another study demonstrated that parenthood largely accounts for this gap, by limiting the short-term scientific productivity of women.11

A survey of grant-funded academic physicians revealed that women spend 8.5 more hours per week on domestic activities than men, with women being more likely to take time off when childcare arrangements failed. Fortunately, this “parenthood penalty” appears to be decreasing over time, although new data suggest that the pandemic has exacerbated this gender difference, likely due to increased caregiving responsibilities taken on by women.12 Notably missing are robust data about these factors in non-binary individuals. 

The lack of representation of women in the science and technology workforce is not new, and organizations have sought creative solutions. For example, IBM has programs dedicated to empowering women’s success in STEM with pioneering steps of hiring women for “high tech” jobs in 1934 and promising women equal pay for equal work in 1935.13  

There have been many initiatives and resources devoted to supporting women’s professional advancement across industries. But IBM’s global study, “Women, leadership, and missed opportunities,” found that, despite increased awareness of imbalances, only one in four organizations make the advancement of women a top 10 priority. The 2021 study found that the pandemic may have driven more women out of the workforce, resulting in fewer women in the pipeline to fill executive roles than there were in 2019.14 

Organizations should look at the structure of their policies and processes to ensure they are building a more equitable foundation. For example, higher education institutions should ensure tenure processes are family friendly. Businesses, like IBM, that offer paid parental leave so any parent can assume caregiving responsibilities for newborns, may help keep all birth parents on their career pathways. These somewhat simple steps can contribute to a more equitable organization. In institutions engaged in scientific or clinical research, such policies may also help to close the sex and gender knowledge gaps around treatment by ensuring diverse perspectives are brought to leadership decisions.

While I’ve cited many statistics, studies and data to support statements in this blog, sex and gender equity in science and clinical research is also a deeply personal issue. As a female surgeon with a PhD in biomedical informatics, I’ve been the “first” many times in my career. While now well represented in many fields, I still routinely hear from brilliant young women who are discouraged at all levels of their education and training. And women have shared with me many experiences of times when their health, or the health of someone they love, has been at risk because of a legacy of health inequities. 

Women deserve better. Now is the time to speak up and make key structural changes to help deliver better quality care for our friends, family members, colleagues, neighbors and ourselves.

Learn more about IBM Watson Health or hear more from Dr. Jackson at her panel at HLTH 2021

(1) Assigned sex at birth is usually based on external anatomy, also referred to as biological sex or sex. https://www.uwmedicine.org/provider-resource/lgbtq/lgbtq-inclusion-glossary

(2) National Institutes of Health Office of Research on Women’s Health Infographic: How Sex and Gender Influence Health and Disease.

(3) https://www.who.int/news-room/q-a-detail/gender-and-health

(4) https://www.jacc.org/doi/abs/10.1016/j.jacc.2015.10.067

(5) https://www.fda.gov/consumers/free-publications-women/timeline-fda-accomplishments-womens-health-1993-present

(6) Zucker, I., Prendergast, B.J. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ 11, 32 (2020). https://doi.org/10.1186/s13293-020-00308-5

(7) Ibid.

(8) https://www.fda.gov/media/143592/download

(9) http://uis.unesco.org/en/topic/women-science

(10) https://news.northeastern.edu/2020/03/05/do-women-publish-less-than-men-in-scientific-fields-turns-out-scientists-have-been-asking-the-wrong-question/  Note: This study does not specifically address non-binary people.

(11) https://advances.sciencemag.org/content/7/9/eabd1996/tab-pdf Note: This study does not specifically address non-binary people

(12) https://www.nature.com/articles/d41586-020-01294-9

(13) https://www.ibm.com/employment/inclusion/downloads/empowering_women_in_tech_ibm_case_study.pdf 

(14) https://www.ibm.com/thought-leadership/institute-business-value/report/women-leadership-2021

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