Study Reveals Women Continue To Be Underrepresented In Clinical Trials

It's no secret that inequalities abound between women and men. While no inequality should be tolerated, some of these imbalances are more serious than others. And in some cases, they could even result in harm. A new study shows that women continue to be underrepresented in clinical trials, which poses a risk to women's health.

Women have historically been excluded from clinical trials, which still lasts today (via Office on Women's Health). In 1977, the U.S. Food and Drug Administration (FDA) issued a guideline banning all women of childbearing age from participating in clinical research studies because certain drugs could cause birth defects

In 1983, a shift away from the exclusion of women began, and a Health and Human Services (HHS) task force on women's health started recognizing that there were many factors influencing the way drugs are metabolized, including body size, hormonal environment, and body fat distribution. This led the National Institutes of Health (NIH) and the FDA to encourage more inclusion of women in clinical trials. 

In 1993, the 1977 policy was rescinded, though women were still severely underrepresented. While the NIH contends that substantial numbers of women and men of different races and ethnicities have participated in NIH research, experts argue there's still plenty of progress to be made.

Why this is dangerous

A new study published in Contemporary Clinical Trials confirms that this inequality is still present today (via U.S. News & World Report). The study, which examined female involvement in cardiovascular, psychiatric, and cancer clinical trials from 2016 to 2019, confirmed that women in clinical trials continues to lag. Researchers analyzed data from 1,433 trials with over 302,000 participants, finding that, on average, only 41% of participants were female. This disparity was especially stark in psychiatry clinical trials, where just 42% of participants were female despite women accounting for 60% of psychiatry patients.

This lack of representation is dangerous, as women are at greater risk of adverse side effects of medications, according to Healthline. Many commonly prescribed drugs were FDA-approved based on clinical trials conducted before 1993 when too few women were enrolled. This could mean more serious side effects and more adverse reactions in women due to how drugs are metabolized in the body, which previous research has confirmed.

Study co-author Dr. Primavera Spagnolo emphasized that while the rise of female participants in clinical trials is promising, further work needs to be done to ensure that more diverse populations are represented (via U.S. News & World Report).