A study conducted by advocacy group For The Breast of Us along with Sommer Consulting sought to determine the factors keeping women of color from participating in breast cancer clinical trials. Founded in 2019, For The Breast of Us is the first online community dedicated to women of color affected by breast cancer.
The study found there were four factors that impact the participation of women of color in breast cancer trials. The factors are logistics, lack of access to healthcare, fear and misunderstanding, and trust. I spoke to Jasmine Souers, a breast cancer survivor, and the founder of For The Breast of Us, and Juliette Faughnan, the President of Sommer Consulting, to get insights on the barriers and what pharma and biotech companies can do to overcome them.
My Life Or My Family
The first barrier is logistics, which includes availability, childcare, and time. The study found the anticipated time demands of a clinical trial are too daunting, as most women are juggling multiple demands in their lives. As primary caregivers and employees, the logistics of participating in a trial makes their lives even more complicated.
One black breast cancer patient who participated in the study noted many women must worry about how to run their household, which can often be led by a single-parent with a single-income. “It’s really hard to just put everything aside and say, ‘I’m going to participate in this’ when you’re worried about how you’re going to make ends meet,” she says. “It’s almost like, do I participate in this trial that may save my life or do I go to work and pay my bills so I can take care of my kids and family. That shouldn’t be a factor that someone has to consider when accepting a clinical trial.”
“Women of color need to be concerned with who will take care of their kids if they take part in a trial,” says Souers. “That is especially true of mothers who do not have a network of family or friends to help. There are a lot of women in the workforce who do not have flexible schedules or employers who will work with them so they can get to doctor’s appointments. Coordinating work schedules is challenging enough with standard treatments. Clinical trial schedules can be far more complicated and demanding.”
Prefilled debit cards or transportation to and from clinical sites are two ways pharma companies can relieve the costs for these patients to participate in trials. A hybrid or decentralized trial, which eliminates some visits to the clinic and allows patients to participate from their homes, can also help patients overcome some logistical challenges. Pharma companies can also work with sites to offer patients evening and weekend hours to enable visits outside of standard work hours.
Access To Clinical Research
The lack of access to quality healthcare systems with connections to clinical trial researchers is the second barrier faced by women of color. The location of hospitals and clinics, insurance and the cost of treatment, and language were three factors mentioned by study participants.
Faughnan states women of color find themselves living further away from those clinically connected hospitals. Although some patients are willing to travel, others have limited transportation options. Unfortunately, Medicare and Medicaid limit their choices even more.
“Several women in the study who are on Medicaid reported having to go to local clinics for care, where they rarely saw the same doctor,” says Faughnan. “Hispanic and Asian women reported language differences as being a significant hurdle keeping them from having access to healthcare opportunities. Providers often do not speak their language and learning materials are rarely translated. This can lead to a sense of frustration and even embarrassment.”
Drug developers can assist with overcoming this burden by working with clinics in minority neighborhoods and ensuring they are staffed with professionals who speak the language of their patients. Drug sponsors can also provide funding to translate pamphlets and educational materials on trials into different languages, and help sites perform outreach to patients explaining the benefits of trials.
Fear And Misunderstanding
The fear of the unknown, the misunderstanding, and not really knowing what trials are or how they work is another issue for women of color.
“This is an education issue,” says Souers. “Going back to the previous challenge, if we're not getting to the patients in the clinics where they're located, it's very difficult to educate them. But there are additional challenges we will face. Even if we get to the places where those patients are receiving their medical care, how do we overcome the fear these patients face? I think education is the key. We are dealing with different cultures, and we know there is not a one-size-fits-all approach. There is a lot to learn about this intersection of race, culture, clinical trials, and the way people prefer to hear and understand information.”
“I think this also comes down to a health literacy issue, which is being recognized more and more in the industry,” notes Faughnan. “Health literacy is about communicating a message that not only is understood but is believable. Broad representation engenders trust. This understanding is one reason why the New England Journal of Medicine has announced that as of January they will start requiring summaries of patient diversity in clinical trials to publish articles. As more and more of the high-impact journals mandate these insights, researchers will need to factor diversity into their study design. If they don’t, they will face a credibility issue.”
Souers believes these changes will also further emphasize the importance of community advocacy groups. These groups have informed and educated personnel who can help women navigate any fears or shame they may be feeling.
In almost every interview conducted for the study, we Souers and Faughnan note they learned about the power of patient communities, and the importance of patients interacting with people from the same community, who look like each other, and who have similar and familiar backgrounds.
“The patient advocacy groups will allow drug companies to understand what needs to be said, how it needs to be said, and how those thoughts need to be disseminated in a way that’s going to be heard,” says Souers. “Then we need to educate the community, so they are aware of and have an understanding of clinical trials.”
A Matter Of Trust
The final hurdle faced by women of color is a distrust of clinical trials and the healthcare industry in general. That distrust goes well beyond the documented Tuskegee experiments of the 1930s. Many black Americans do not trust healthcare providers to act in their best interests. In fact, research has found that black people are much less likely to report trust in their physicians and hospitals and are therefore less likely to seek treatment. Sadly, studies have also found that when black and white patients have the same disease, black patients are more likely to die sooner. An article in The Hill reports black people are three times more likely to die of asthma and have a 25% higher cancer death rate. Black women also have a 20% higher cancer death rate than white women.
Unfortunately, some of the distrust is the fault of drug development companies conducting clinical trials. Sponsors will engage with ethnic communities before and during a trial to build trust in those communities and encourage trial participation, only to walk away at the end of a study. More needs to be done to develop long-term connections in those communities that last beyond the length of the trial itself.
Interacting with patients in their clinics, churches, and community events would be a step towards eliminating some of that distrust and building closer relationships with patients and their families.