When Edward Garon was a junior investigator at the University of California, Los Angeles (UCLA), about a decade ago, a colleague found him an ideal patient for a lung cancer clinical trial. “I was very excited,” Garon recalls. There was just one problem: The patient only spoke Spanish.
In order to enter the trial, the patient had to comprehend—and sign—dozens of pages of documents, agreeing that she understood the trial’s risks as well as its time and logistical commitments. Garon could have had the documents translated to Spanish, but he wasn’t sure whether he had the budget for it. “I remember the anxiety I felt,” he says.
Garon eventually found the money, translated the documents, and enrolled that patient. But the experience left him uneasy. If he had this much trouble getting one non–English-speaking person into his trial, how many other underrepresented groups were being left out of clinical trials across the country?
Now, a new study led by Garon finds that well-funded private trials enroll non-English speakers at about twice the rate of publicly funded trials. That may be because the less well funded trials can’t afford to translate consent documents, preventing non-English speakers—who often belong to underrepresented racial and ethnic groups—from enrolling.
“This is the first paper to my knowledge that is really showing that [language barriers] translate into a possible decrease in trial recruiting and even trial screening,” says Mohana Roy, a medical oncologist at Stanford University’s School of Medicine, who was not part of the work.
“There’s this huge national effort to improve inclusiveness on our current clinical trials,” Roy explains. But Hispanic people, Asian people, and people of other races and ethnicities remain underrepresented. A recent analysis of phase 1 clinical trials for anticancer agents found that Hispanic people represented only 3% of participants, for example, even though they make up 19% of the U.S. population. Language barriers are a key impediment, Roy says. “Communication is at the cornerstone of clinical trials.”
To figure out just how much of an impediment language is for clinical research, Garon, now a physician scientist at UCLA, and colleagues gathered more than 12,000 documents that patients signed in order to participate in clinical trials at the university’s cancer center from 2013 to 2018. The team analyzed the proportion of documents that were signed by patients whose primary language was something other than English—about 750—and those with limited English proficiency—close to 500. The most common non-English languages were Spanish and Chinese.
Eight percent of patients whose primary language was not English participated in trials funded by private industry, the team found. But only about half that number, 4.4%, participated in trials funded by the government, academia, or philanthropy. The results were similar for patients with limited English proficiency: Five and a half percent signed consent forms for industry-sponsored trials, but only 2.8% signed consent forms for trials not funded by industry.
In addition, in the privately funded trials, 70% of patients with limited English proficiency signed consent documents in their primary language, whereas in the nonindustry trials only half of them, 35%, did so.
Privately sponsored trials tend to be better funded, and thus have more money available for translation. Garon and his colleagues conclude that translation costs had kept many non-English speakers out of the non–industry-funded trials, they report today in Nature.
Although the results come from only one cancer center, the language barrier likely also affects clinical trials in other medical specialties, says María Vélez, a hematology oncology fellow at UCLA and first author of the study. “This is a problem that investigators face across the country.”
The costs of translating forms can vary depending on the amount of paperwork and the number of languages needed, Garon says, which makes it hard to budget for these expenses in grants. “I didn’t anticipate how complex this was,” he says. “This has been tremendously educational for me and my team.”
But Roy says providing such services is critical. “In in the big scope of a large, phase 3, clinical trial on cancer, that is really such a small percent of how much these trials cost.”
Providing more funding for translation would help diversify the patient population, she adds. That, in turn, would make the results valid for a broader spectrum of patients, she says. Right now, some approved cancer drugs don’t work as well in minority groups because they were mainly tested in white, English-speaking populations.
Tackling the language barrier should be a priority, agrees Luis Carvajal-Carmona, a cancer health equity researcher at UC Davis who was not involved in the study. “Funding agencies must take notice.”
Half the population in Los Angeles is Hispanic, Carvajal-Carmona says, yet most trials covered in the new study did not offer consent documents in Spanish. In states with a majority of Hispanic patients such as California or Texas, he says, “I think every protocol should have a consent form in Spanish”—especially because Hispanic populations are growing.
Other structural barriers can thwart more diverse clinical trials, such as mistrust of the health care system, transportation and child care costs, and lack of insurance. But racial and ethnic minorities are as willing as white people to participate in research if asked, Roy says. “Language is something so actionable,” she says. “We can really put resources, in real time, in a short time period, and act on it.”
