HealthDay News — Sex-based gaps still persist in women’s participation in drug and device clinical trials, according to a study published in the April issue of Contemporary Clinical Trials.

Alexandra Z. Sosinsky, from Brigham and Women’s Hospital in Boston, and colleagues analyzed data from ClinicalTrials.gov on US-based, pharmaceutical industry or government-funded phase 1 to 3 clinical trials (2016 to 2019) to compare proportions of women enrolled in trials for adult cardiovascular, psychiatric, and cancer drugs and devices.

The researchers found that across 1433 trials (302,664 participants), on average, 41.2% of participants were women. Women were consistently underrepresented vs their proportion of the disease population (cardiovascular disease: 41.9% female participants vs 49% female population with cardiovascular disease; psychiatry: 42% clinical trial participation vs 60% of patient population; cancer: 41% clinical trial participation vs 51% of patient population).


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“The rise of female participants in clinical trials is certainly promising, but our work is not complete. We simply cannot rest,” a coauthor said in a statement. “To ensure that our patients are properly cared for and drugs as well as devices are truly safe and effective, we need to continue monitoring women’s representation in clinical trials by disease area and, importantly, we need to develop interventions and approaches ensuring the inclusion of a diverse group of women in clinical research.”

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