What could fix cancer clinical trials’ longstanding diversity problem?

There’s a diversity problem in cancer clinical trials, and few know this better than Stephanie Walker. When she was diagnosed with stage 4 metastatic breast cancer, Walker said there was no one to help her figure out the system, not even a nurse or patient navigator.

“I was told, ‘Well, you’re a nurse, you know you got this, you know it all,”’ said Walker, a hospice nurse for over 40 years and a patient advocate. “Technically, I didn’t.”

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A lot of what she learned about navigating the health care system as a cancer patient she picked up while sitting in the waiting room, like learning that she could have access to a nutritionist or a social worker. And, so far, no researcher has invited her to participate in a clinical trial.

“I’ve been living with metastatic breast cancer — July the ninth was eight years — no one to this date has ever mentioned clinical trials to me,” Walker told the audience as part of a panel discussion on clinical trials during the 2023 STAT Future Summit Wednesday.

When clinical trials do not include patients like Walker, a Black woman, it impacts the quality of data, making it difficult to know how the study’s findings apply to the population groups that were not represented, or underrepresented, in the trial. Multiple studies have found that only 4%-6% of cancer trial participants are Black and only 3%-6% are Hispanic, despite these population groups representing 15% and 13% of people with cancer, respectively.

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“We know that in oncology, only 8% of adult cancer patients take part in trials,” said Judy Sewards, the head of clinical trial experience at Pfizer. “And then when we look at our Black and Hispanic and other populations, that number goes down as we go forward.”

Sewards suggested three ways to recruit more diverse participants in clinical trials — by engaging the community you want more participation from, listening and learning from those interested in participating, as well as seeking feedback from advocacy groups before a clinical trial design is finalized.

“If you build it we will come, if you let us know, but you got to get us there,” Walker said about the importance of communicating with underrepresented groups. She emphasized that additional barriers like finances, meals, distance, or a lack of transportation could also keep people from participating in clinical trials.

A clip from a panel on diversity in cancer clinical trials at the 2023 STAT Future Summit. STAT

Creating clinical trials that translate into the best treatment options for patients will also take time, said Carmen Calfa, associate director of community outreach for Sylvester Comprehensive Cancer Center in Miami. “Hiring people that look like our patients, having research nurses that speak different languages, translating every single informed consent form and information about the trial in three languages: all those things have helped us connect with our patients.”

Calfa said having a diverse team and a diversity, equity and inclusion director at Sylvester Center led to changes including a clinic on wheels that was introduced in 2018 where patients were screened for high PSA levels, a widely used biomarker for prostate cancer.

“And if we diagnose someone with prostate cancer, guess what? He already trusts us. We’ve been there. We met with him and his family,” said Calfa. “Trust is the easiest thing to lose and the hardest thing to build.”

Walker added that for community engagement to work, outreach staff need to look like members of the community. “You have to gain that trust and you do that by boots on the ground,” she said. “You’re not going to be able to send a white woman in high-heeled pumps and a miniskirt into the hood to talk to them about clinical trials and establish trust. It’s never going to happen.”