Gender representation in clinical trials is progressing, but not at equity. When we layer in race and ethnicity, women of color—particularly Black women—are largely absent from current clinical trial research. For instance, the breast cancer mortality rate for Black women is 40% higher than for white women, yet, nearly half of Black women with advanced forms of the disease never receive information about clinical trials. Even with a disease like dementia, Black women are at greater risk when race and gender intersect. Despite the risk and prevalence, less than 3% of Alzheimer’s disease clinical trial enrollees identified as Black or African American.
As someone who’s spent nearly a decade building digital frameworks that peel back the layers of identity to reach marginalized communities through inclusive communications, I realized that these health equity gaps might be the result of communication gaps.
While women represent 50% of the U.S. population, they generally account for just 15% to 36% of clinical trial participants. The vast majority of biomedical research was conducted exclusively on white men until laws and regulations were passed requiring the inclusion of women and minorities in clinical studies funded by public money–like those from the National Institutes of Health (NIH). That means that up until 30 years ago, approved medications, vaccines and devices were exclusively tested on heterosexual, non-disabled, seemingly healthy white men.
Diverse representation in clinical trials directly influences a drug’s efficacy and how well an individual or patient community will respond. A separate study focused on the response to chemotherapy before surgery for breast cancer patients concluded that, “We need more research on the biology of breast cancer tumors in Black women to understand why these tumors are more aggressive.”
When we don’t ensure that people from across social identities are represented in the research, we generalize our medicine and operate under the assumption that what works for one will work for all.
Uncovering why Black women are absent from health research
In public health circles, terms like “hard-to-reach” are used to describe groups of people who may not conform to standard communication messages or tactics. As someone with familial roots in southeastern Alabama, I’ve always wondered, “Are they talking about members of my family?” Perhaps. But what’s most striking is the assumptions we make, the narratives we assign to these communities and the implications they have on our health.
I became more interested in the use of the term when developing strategies to reach Black women about clinical trials. Black women are often placed in the “hard to reach” category when it comes to participating in health research, but I didn’t think that was true or, at minimum, the full story. One day, I asked my mom whether she had ever been asked to be a part of a clinical trial.
“No, I don’t believe so,” she said.
I followed up with, “Well if you were asked to participate in a clinical trial, would you say yes?”
“Yes,” she replied, “especially if I knew my participation would help other people.”
With my mom’s observation in mind, my colleagues at GCI Health and I created an online survey to determine how Black women view clinical trials and the drivers that might get them to participate. In seeking to understand how Black women perceive clinical trials, the outcomes were multidimensional and layered.
We started by asking 500 Black women the same question I asked my mother: “Have you ever been asked to participate in a clinical trial?”
Seventy-three percent of Black women said they’ve never been asked to participate in a clinical trial. Then, when we asked about their likelihood to participate in a clinical trial if asked, 80% of Black women said that they would be somewhat or very likely to participate. When we consider absence in clinical trials, Black women are rarely allowed to opt in. Simply stated, Black women are not “hard to reach,” we’re just hardly reaching them about the potential to participate.
The path to bringing parity to clinical trials
We can develop better and more precise medicines with better and more focused research. Below are a few crucial steps that can have a direct positive impact on increasing diversity in clinical trials.
Policies that shift clinical trial diversity
Recognizing the need to ensure research is more representative so that diversity is the cornerstone of drug development, government agencies are taking the lead. In spring 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for “developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.”
FDA commissioner Robert Califf shared that, “Achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”
In late 2023, President Joe Biden and Dr. Jill Biden called for more investment into women’s health research. “I have always believed in the power of research to save lives and to ensure that Americans get the high-quality health care they need. To achieve scientific breakthroughs and strengthen our ability to prevent, detect, and treat diseases, we must be bold,” President Biden shared in a statement.
Champion clinical trial education
Primary care providers can consider adding basic information about clinical trials in their offices. Whether placing brochures in waiting areas or displaying attention-grabbing posters in exam rooms, these can be easy point-of-care opportunities to educate patients about health research. Together, academia, biotech partners, advocacy groups and healthcare professionals can instill trust and increase participation through consistent clinical trial education.
Reframe trials as something everyone can be a part of
Eighty percent of Black women are willing to participate in a clinical trial, but most haven’t been asked to participate. Let’s set aside potential barriers that participants might have to overcome. Instead, consider that, by starting the conversation, addressing concerns and simply making the ask, we might encourage patients to become volunteers for health research.
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