Kathryn G. Schubert
MPP, President and CEO, Society For Women’s Health Research
Five years ago, the first-ever drug for female sexual dysfunction came to market. But before the Food and Drug Administration (FDA) approved the drug, the agency required the company to conduct a safety study on how the drug interacted with alcohol. That study included 23 men and only 2 women. For a drug intended to be used by women.
Medical research has long had a gender problem.
Until about 25 years ago, almost all medical research in the United States was conducted on men. Most women were excluded because researchers believed that female hormonal cycles were too difficult to manage in experiments and that using only one sex would lead to better results. These biases overlooked fundamental differences between women and men and put the health of women at serious risk.
Advocacy groups like the Society for Women’s Health Research (SWHR) fought for the inclusion of women and minorities in clinical trials, and now women are routinely included in most major medical research studies in the United States. In fact, women made up 72 percent of all clinical trial participants for FDA-approved new drugs in 2019, up from 40 percent in 2015.
Despite this progress, knowledge gaps in women’s health and barriers to women’s inclusion in research remain. Some therapeutic areas are not making as much progress as others when it comes to inclusion of women in research.
For example, in clinical trials for FDA-approved new cancer therapies last year, only 38 percent of participants were women. In another disheartening example, the FDA approved an HIV prevention therapy last year, but only for use by men and transgender women who have sex with men because the drug manufacturer did not include cisgender women in its studies. Yet in 2019, girls and women accounted for nearly half of all new HIV infections globally.
Much work also needs to be done to increase diversity in clinical trials, especially among racial and ethnic minorities. The vast majority of participants are white, and the percentage of Black participants in clinical trials for FDA-approved new drugs actually decreased from 11 percent in 2018 to 9 percent in 2019.
Women and people of color often face greater challenges to participation in research for a variety of reasons, including barriers to care and access, historical distrust of the medical community, increased caregiving responsibilities, indirect costs of participation, language barriers for non-English speakers, and lack of clinician and patient knowledge of clinical trials.
We need innovative practices to bolster the recruitment and retention of women and other underrepresented populations in clinical trials.