Sex and Gender in Clinical Research: Breaking Through Barriers, Advancing Equality in Outcomes
Biological gender differences in men and women matter – but historically, women have not received the appropriate study and resulting treatment that underlies this belief. This was the opening message delivered by Dr. Alyson McGregor in the Ground Rounds: Great Teachers videocast on Oct. 14 titled Sex and Gender Based Research: Yesterday's Neglect, Tomorrow's Opportunity. McGregor is Associate Professor of Emergency Medicine, at Brown University, serving as Director of Sex and Gender Emergency Medicine.
Starting with an earlier belief that men and women were comparatively the same except for their reproductive systems, studies subsequently showed that different diseases affect men and women in variable degrees of incidence and severity. Other earlier studies had also included more men, even for conditions that more often affected women according to McGregor.
With this in mind, the NIH Revitalization Act of 1993, formal changes were made to include more women and minorities in clinical research and any resulting drug development. Because certain drugs affect women differently than men (often resulting in incorrect dosage amounts) changes were made in studies to account for this and other gender-based differences – and assure these were observed in study data analysis. In early 2016, including sex as a biological variable in NIH grant requests became mandatory.
Gender differences at the visible trauma level also matter, for example, men being more likely to suffer occupationally related physical accidents – from machine operation or construction for example, and with cars (having been primarily designed with male crash test dummies) which may have led to higher incidence and severity of physical trauma and death for females in automobile accidents.
McGregor believes that gender differences need to be observed right down to human DNA – as male and female chromosomes are found in cells in all organs, all affecting organ functions and responses. She also cited a problem in which cell-based researchers in some cases do not know the sex of the cells they are studying, and that male animals are more often used in animal studies. Gender based variables can also complicate interaction with doctors – men and women describe physical sensations and symptoms differently and appropriate treatment may be delayed based on how these are described by the patient and understood by the treatment team.
She further cites COVID-19 studies as a real-time example how illness can affect men and women differently; citing rates of hospital admissions and studies showing that the male death rate from the virus exceeds that of women. But both sexes have minor advantages over the other in the body's response to COVID-19 infection, and reactions to experimental vaccines can be affected by age and hormone levels. McGregor concluded by discussing what the research community is currently doing to account for gender based differences in research that leads to new drugs and treatments. From initial grant reviews, through authorship and pre-publication peer review, all data will be reported and evaluated with gender differences, with sex-based biological variables accounted for, having the ultimate goal of reducing different gender-based outcomes in healthcare delivery.
McGregor has recently released a new book "Sex Matters: How Male-Centric Medicine Endangers Women's Health and What We Can Do About It."
- Robert Burleson