Nicole Woitowich: Clinical trials are better at including women. But data analysis is still a real problem.

14 July 2023

The summer of 1993 was an eventful time: Prince changed his name to a symbol, “Jurassic Park” was released and Congress passed the National Institutes of Health Revitalization Act requiring the inclusion of women in clinical research.

Most people aren’t aware of this law, which requires that women be included in research to develop drugs, therapies and treatments that are designed to improve the health of all people. For decades, women were underrepresented in or excluded from biomedical research studies because they could become pregnant or their hormones were deemed “too complicated.” This caused large gaps in our understanding of how sex and gender inform health and disease.

Because men made up the majority of research participants, women’s health suffered. Drugs, therapies and medical devices were developed with the male patient in mind. A 2001 Government Accountability Report found that eight out of 10 drugs pulled from the market had greater health risks for women than for men. And in 2013 — a full 21 years after the sleep aid had been approved by the Food and Drug Administration — the FDA released the first sex-specific instructions for the prescription drug Ambien after women experienced significant side effects due to the fact that men and women metabolize the drug differently.

Flash-forward to the present moment: The NIH Revitalization Act has just entered its fourth decade. As a biomedical scientist who studies the intersection of sex, gender and science, I know this for certain: We still have a far way to go.

Most drugs and therapies are developed in laboratories and tested in cells or animals before they are eligible for clinical trials. However, for the first 20-plus years after the legislation was passed, the idea persisted that females — humans, rodents or otherwise — were simply “too complicated” to study. Scientists favored the use of male research subjects, leaving us with an often one-sided view of biology. In response, the NIH introduced a policy in 2016 requiring scientists to consider the sex of their subjects when designing experiments and reporting and analyzing their data.

Now scientists are more likely to include both sexes in their research studies, and women account for approximately 48% of clinical trial participants. That’s phenomenal progress, but there’s still one major problem: Scientists routinely fail to analyze their data by sex. When this happens, we have no way of knowing if males or females respond to treatments differently or if there are fundamental differences in the way they are affected by certain diseases or disorders — the differences get flattened by grouping the data together.

Analyzing data by sex helps us understand why some conditions are more common in men than women (or vice versa) and enables us to develop more effective, personalized medicine. It could also shorten the amount of time it takes for a drug to be developed and introduced to patients, which currently takes 10 to 15 years. Some patients simply don’t have that kind of time to wait.

Recent studies have found that female scientists are more likely to analyze their data by sex compared with men. Whether they were motivated to do so by personal interests or an increased awareness of how sex and gender inform human health and disease remains less clear.

Maybe it’s because women refuse to view themselves as complicated research subjects.

We believe our data is worth collecting and analyzing. We know how crucial it is to have information regarding drug safety during pregnancy or to know how certain treatments may affect our menstrual cycles. (I’m looking at you, COVID-19 vaccines.) We know that women are disproportionately affected by Alzheimer’s disease, autoimmune diseases and certain types of cancers and are diligently working toward better treatments or cures.

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Yet, because women are underrepresented in the biomedical workforce — particularly in leadership roles — our research questions remain unasked and unanswered, and our work underfunded.

The lack of investment in women’s health research has economic consequences in addition to scientific ones. A report by Women’s Health Access Matters, a nonprofit focused on health research and investment, found that investing $350 million in women-specific research would generate more than $14 billion in returns to the U.S. economy through increases in life expectancy, disease progression and quality of life.

Thirty years from now, I will be 67 and hopefully nearing retirement as I take my grandkids to see the 12th Jurassic Park sequel. I do not want to spend the rest of my career advocating for women’s health.

We have the ability to transform women’s health in three years, not 30 (#3not30), by investing in women’s health and the female scientists who are just as impatient as I am for change.

Nicole Woitowich, Ph.D., is a biomedical scientist at Northwestern University Feinberg School of Medicine in Chicago. She wrote this column for the Chicago Tribune.

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