By Sophia Kenward, SWHR Communications and Policy Intern
After decades of being underrepresented in biomedical research, women have accounted for more than 50% of participants in clinical trials for FDA-approved new drugs in the past four years. Despite this progress, more work needs to be done to ensure the appropriate inclusion of women, people of color, and other groups who experience health inequities in research.
The Food and Drug Administration (FDA) recently published its 2020 Drug Trials Snapshots Summary Report. Published annually since 2015, the report highlights the diversity of participants in clinical trials for newly approved drugs and biologics in a calendar year.
Last year, women made up 56% of participants, as compared to 40% in 2015. In 2020, drug trials for conditions that disproportionately affect women reported particularly high rates of women participants, including treatments for migraine, breast cancer, overactive bladder, and thyroid eye disease. SWHR previously wrote about the extraordinarily large number of women participants in 2019, when women accounted for 72%. That high percentage was influenced by the large number of drugs approved that year for conditions that predominantly affect women, such as migraine, rheumatoid arthritis, and insomnia.
While these top-line statistics appear to show women are being included in adequate numbers, the high numbers of women in certain therapeutic areas like neurology and gynecology can mask gaps in therapeutic areas like cardiovascular disease and infectious disease, where women continue to be underrepresented.
SWHR was founded 30 years ago to advocate for the inclusion of women and minority groups in clinical trials. These groups should be included in drugs trials in numbers proportionate to their prevalence in the patient population of the disease being studied in order to ensure medications are safe and effective for them. Globally, women report more adverse side effects from drugs than men, potentially as a result of inappropriate dosages or sex-based biological differences.
Clinical trials still have a long way to go to be truly representative of the diverse U.S. population. Only 8% of participants in clinical trials for FDA-approved new drugs in 2020 were Black or African American, despite this community making up an estimated 13% of the U.S. population. Another recent FDA report shows that most Black or African American clinical trial participants for FDA-approved new drugs from 2015-2019 were enrolled at U.S.-based study sites. This population accounted for 16% of U.S.-based participants compared to only 2% of participants enrolled at sites outside the U.S.
This aligns with a recent study in the journal Cancer that reported clinical trials conducted primarily outside the United States were twofold less likely to enroll Black participants than U.S. clinical trials. “The globalization of cancer clinical trials may have the unintended consequence of further exacerbating existing racial disparities in cancer clinical trial representation and ultimately the generalizability of trial results,” the authors concluded.
The number of Hispanic participants in clinical trials for FDA-approved drugs dropped significantly, according to the Snapshots reports, from 18% in 2019 to 11% in 2020. Hispanics make up an estimated 18.5% of the population. Asian people accounted for 6% of participants in 2020, in line with their representation of the overall U.S. population.
In 2020, the COVID-19 pandemic exacerbated gender and racial disparities that have existed for centuries and that affect our health and wellbeing. People of color are disproportionally affected by COVID-19, yet they have been underrepresented in research trials for the COVID-19 vaccine, leading to calls to recognize and address the underrepresentation of these groups.
SWHR continues to advocate for greater inclusion of women and underrepresented populations in clinical research trials in order to eliminate health inequities. To diversify participation in clinical trials, we must address barriers to participation and recognize the role of social determinants of health. Addressing diversity and inclusion in clinical trials is crucial to ensure the health and safety of all people.