Women Remain Underrepresented in Clinical Trials

THURSDAY, June 23, 2022 — 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 U.S.-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 1,433 trials (302,664 participants), on average, 41.2 percent of participants were women. Women were consistently underrepresented versus their proportion of the disease population (cardiovascular disease: 41.9 percent female participants versus 49 percent female population with cardiovascular disease; psychiatry: 42 percent clinical trial participation versus 60 percent of patient population; cancer: 41 percent clinical trial participation versus 51 percent of patient population).

“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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Posted June 2022