No English? No trial: Patients left out of cancer research

People with culturally diverse backgrounds are more likely to be left out of medical trials, researchers say.

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People from culturally and linguistically diverse (CALD) background are routinely left out of medical trials due to several systemic barriers, according to a survey of the Australian cancer clinical trials workforce.

The main barriers were time pressures during consultations, a lack of trial materials including questionnaires in languages other than English, difficulty accessing interpreters quickly and anxiety about meeting the bar for informed consent, the researchers said.

The survey of 91 clinical researchers found that there may also be deeper issues at play, such as “inherent bias” among clinicians and “structural racism” in clinical trials.

“I think most clinicians have all experienced the thought process of considering that a particular patient in front of them is not a trial patient because of perceived low health literacy, perceived concerns regarding adherence to protocol, or just simply in the too-hard basket in a busy public hospital clinic,” one respondent summarised.

The survey also found that 74% of clinical researchers did not collect data on CALD patient enrolment in cancer trials.

“Our survey indicated there are limited resources currently in place to support recruitment of patients from diverse backgrounds and there is a clear opportunity to improve data collection of patients being screened for and enrolled in Australian cancer clinical trials,” they wrote in JCO Oncology Practice.

The researchers said specially designated “trial navigators” who would help patients access trials, and access to cancer trial materials in multiple languages, were the most promising solutions.

Lead researcher and medical oncologist Dr Abhijit Pal said “the elephant in the room” was that the population recruited to cancer clinical trials were culturally homogenous.

“They have been predominantly Caucasian and that finding has been replicated all over the world, even in America where they have large black and Hispanic populations,” Dr Pal told The Medical Republic.

It’s the same case in the UK, Canada and Australia, where people from non-Caucasian backgrounds enrolled at a lower rate, said Dr Pal, a PhD candidate at the University of Sydney.

“It’s a problem not just for equity of access for that population, but also for the science,” Dr Pal said.

“When you don’t include everyone, the science you produce doesn’t represent the community.It’s a distorted picture and the results are not generalisable. It’s not really science anymore.”

Dr Pal is a medical oncologist working at Liverpool and Bankstown hospitals in South Western Sydney Local Health District, which has a large population of patients for whom English is not the preferred language.

With an English-speaking patient who wanted to take part in a trial, Dr Pal said he would spend about 45 minutes going through the information.

“Enrolling on to a cancer clinical trial is really complex. I have to go through their anxiety, their prognosis, randomisation, additional research procedures and the uncertainty associated with the new therapeutic. There’s a lot of information to get through.

“When someone who’s Vietnamese-speaking comes into my room, I have to use an interpreter and it’s going to take me about twice as long as everything I say needs to be repeated by the interpreter.

“And in addition, that population is often facing other disadvantages. They have less money, less education, less literacy, and these associated factors compound the issue even more in terms of successfully enrolling on to a cancer clinical trial.”

So it was not surprising that those populations were often excluded due to the structural racism that blocked these patients “at every step of the way”, he said.

Dr Pal said taking part in a cancer clinical trial was like “business class treatment” for patients.

Patients with high literacy, connections and mobility were able to ask for trials and travel to the relevant trial centres because they also knew that cancer trials represented hope, he said. Those who were not aware of this option simply missed out, he added.

“A clinical trial is seen as ‘extra’, but in a well-resourced setting the standard of care is a clinical trial.”

Dr Pal said some communities had trouble trusting institutions, whether that was for historical or other reasons.

“Clinical trials are really hard, especially in cancer,” he said.

“Cancer is incredibly emotional. Often these patients have a terminal illness and they have limited time. And the decision to go on trial means you accept uncertainty, and you accept that during the time you have left, people will contact you and you’re putting a lot of trust in institutions.”

“In Australia we have a panoply of different communities and ethnicities, and it reflects Australia’s migration waves over the last six decades,” he said.

“If you speak another language, we should celebrate that and we should find out how we can make sure you’re included, as opposed to: ‘if you don’t speak English, you lose’.”

In the US, patients from historically under-represented racial and ethnic groups were enrolled in cancer clinical trials at disproportionately low rates in the US and countries with large immigrant populations, according to an accompanying editorial.

The US Food and Drug Administration has mandated black and Hispanic recruitment in clinical trials.

“Like all things in life, you can ask nicely, but we can also legislate for it. So now drug American drug companies setting up trials are forced to ensure sites recruit minorities and provide a recruitment plan,” Dr Pal said.

“That’s not happening in Australia at the moment, but I’ve spoken to the Australian arm of pharmaceutical drug companies about diversity in trials, and it’s definitely an area of interest.”

Dr Pal is now co-designing a trial navigator for Arabic-speaking patients with cancer in NSW, with support from Cancer Institute NSW and working with the Arabic Council of Australia, South West Sydney Multicultural Health Services and Arabic consumers.

“True secular multiculturalism is where we celebrate all our differences, and don’t expect everyone to conform to one particular language,” Dr Pal said.

“Our healthcare systems should invite, welcome and celebrate those who prefer a language other than English as opposed to excluding them and putting in implicit or explicit barriers to their care.”

JCO Oncology Practice 2023, online 7 September