As COPD Rates Rise in Women, Clinical Trial Representation Lags
NYMC Study Identifies a Persistent 20 Percent Gap in Women’s Enrollment in COPD Clinical Trials
/filters:quality(70)/prod01/channel_58/media/schools-and-colleges/nymc/images/som-dean-newsletters/MuhammedUmer.jpg)
Historically perceived as a predominantly male disease, chronic obstructive pulmonary disease (COPD) is now increasingly recognized as a large and growing health concern among women. Yet women remain significantly underrepresented in COPD clinical trials, according to a study by New York Medical College residents, published in the International Journal of Chronic Obstructive Pulmonary Disease.
“What was particularly notable in our findings was the magnitude and consistency of just how much women were underrepresented across trials—about 20 percent,” says Muhammed Umer, M.D., an internal medicine resident in NYMC’s Internal Medicine Residency Program at St. Michael’s Medical Center in New Jersey, and lead author of the study. “Clinical trials form the foundation for treatment guidelines. If certain groups are underrepresented, it raises serious concerns about how well those results apply to the broader patient population.”
Since 2008, epidemiologic trends have revealed a striking convergence in COPD prevalence between men and women. Despite lower tobacco exposure, rates of COPD among women have risen significantly and now account for the majority of cases. Yet when the researchers looked at data from 190 clinical trials, which included 217,630 patients with COPD, just 32 percent were women.
“Even as awareness of COPD in women has grown, clinical trial enrollment has not kept pace,” says Dr. Umer. “This gap matters because women often experience COPD differently than men, with more shortness of breath, distinct lung disease patterns, varied responses to inhalers, higher rates of anxiety and depression, and, in some cases, an even faster decline in lung function.”
Underlying anatomical and physiological distinctions between men and women contribute to this divergence. Women typically have smaller airway diameters relative to lung volume, greater biological sensitivity to airborne pollutants, and hormone-related differences in immune responses that may intensify lung inflammation.
“Recognizing these differences is critical to accurate diagnosis and effective treatment,” says Dr. Umer. “Equally important is ensuring that clinical trials accurately reflect the populations affected to ensure treatment works for everyone. While inclusion of women has improved, a significant gap remains—closing it will require intentional changes in trial design, recruitment, and reporting to ensure more inclusive, precision-based care.”
