Study: Gender Representation in Trials in Different Therapeutic Areas
A study that assessed tens of thousands of U.S. clinical trials has found that men and women are both underrepresented in trials across a number of therapeutic areas, though women faced underrepresentation in the most areas.
The study, led by Northwestern University and published in JAMA Network Open, conducted a cross-analysis of 20,020 trials between 2000 and 2020 and found that women are not adequately represented in cardiology, oncology, neurology, immunology, urology and hematology trials relative to disease burden. The cardiology and oncology trial findings were especially worrisome, the researchers said, given that cardiologic and oncologic disease are the leading causes of death for females in the U.S.
In addition, the researchers discovered that men faced underrepresentation in musculoskeletal disease and trauma, psychiatry and preventive medicine trials. The finding was also particularly alarming given the substantial contributions of suicide, violence and substance use to growing morbidity and premature deaths among U.S. males.
The authors believe their study is the first one to look at sex bias across all U.S. human clinical trials relative to disease burden, the prevalence of disease based on sex, ethnicity and other factors.
“Sex bias in clinical trials can negatively impact both men and women by creating gendered data gaps that then drive clinical practice,” said Jecca Steinberg, first author of the study and a medical resident at Northwestern University Feinberg School of Medicine’s department of obstetrics and gynecology. “Neglecting one sex in clinical trials — the gold standard of scientific exploration and discovery — excludes them from health innovation and skews medical evidence toward therapies with worse efficacy in that sex,” she said.
The researchers concluded that while there have been numerous initiatives to increase female representation in clinical trials over the past three decades, bias persists within certain areas for both genders, though equity has improved.
Read the JAMA article here: https://bit.ly/3jbWenm.