February 21, 2020

Women Make Up 72% of Study Participants for FDA-Approved New Drugs in 2019

By Emily Ortman, SWHR Communications Director

As SWHR celebrates our 30th anniversary this year and our decades of work to ensure the inclusion of women in research, we are thrilled with the news that women accounted for 72% of all clinical trial participants for FDA-approved new drugs in 2019.

SWHR was founded in 1990 with the goal of getting women into medical research at a time when they were being intentionally excluded. The fact that women made up 56% of study participants for newly approved drugs in 2018 and 72% in 2019 shows how far we have come.

In 2015, the first year the Food and Drug Administration (FDA) released the Drug Trials Snapshots report to make demographic information easily available to consumers, women accounted for only 40% of participants. That number has increased each year since then.

The high proportion of women in 2019 drug trials also reflects the significant number of therapies approved for conditions that predominantly affect women. For example, clinical trials for new treatments for migraine, iron deficiency, insomnia, irritable bowel syndrome, and rheumatoid arthritis had a large majority of women, mirroring the higher prevalence of these conditions in women.

In addition, six of the 48 approved drugs had only women in their clinical trials, which tested treatments for postpartum depression, breast cancer (2 drugs), osteoporosis in postmenopausal women, and hypoactive sexual desire disorder, as well as a tool for detection of fallopian tubes blockage in women with infertility.

Despite the positive news for women, work remains to be done to increase diversity in clinical trials, and specifically the participation of African Americans. In 2019, 72% of participants were white, compared to 69% in 2018. The percentage of black participants decreased from 11% in 2018 to 9% in 2019 (though still better than the 5% in 2015), while Hispanic participants increased from 14% in 2018 to 18% in 2019. According to a recent estimate, African Americans make up about 13% of the U.S. population, while Hispanics account for about 18%.

Moving forward, SWHR will continue its work to advocate for the inclusion of women and underrepresented populations in research in numbers proportionate to the prevalence of the disease being studied. Without the appropriate inclusion of diverse groups in research, we cannot discover how certain diseases or treatments affect people differently. Diversity and inclusion are critical to scientific progress.