Equity in clinical trials? Just add money and motivation

Advances in cancer treatment will not be enjoyed equally without a concerted effort to improve the representation of people from culturally and linguistically diverse (CALD) backgrounds in clinical trials, the MOGA 2022 meeting was told.

Medical oncologist Dr Abhijit Pal from the Liverpool Hospital in NSW told delegates there was local and global evidence for the under-representation in clinical trials of people from ethnic minorities and with CALD backgrounds.

For example, a retrospective NSW study of almost 20,000 cancer patients found trial participation was significantly lower in CALD patients than non-CALD patients (5.7% v 8.4%) – driven by even lower participation in the subgroup of CALD patients whose preferred language was not English (3.9%).

Dr Pal told the meeting that the 2021 Census indicated Australia continues to become even more diverse – with the proportion of Australian residents born overseas or having a parent born overseas now at 51.5%.

He said equity, diversity and inclusion in the clinical trial population was fundamental to generalising pivotal trial results to the community.

This had been recognised by the FDA which was mandating the inclusion of underrepresented racial and ethnic populations in the US into clinical trials.

Dr Pal presented the results of an online survey of 91 people recruited through Australian cancer trials groups. Most were from NSW and Victoria – Australia’s most culturally diverse states – 68% were clinicians and 87% were involved in trial recruitment.

The survey found that 74% of sites did not collect routine data on preferred language or ethnic background suggesting there was no way of knowing how well or otherwise they were doing.

“If we are not measuring, we can’t improve or check so… there is room for improvement,” he said.

Participants in the trials workforce identified communication as the biggest perceived barrier (49%) compared to other factors such as mistrust (14%) and opportunity barriers (12%).

Communication issues included patients with low English proficiency, low health literacy, the lack of translated materials and interpreters, the lack of simplified information and difficulty communicating the study rationale.

“It’s a very complex problem. At the patient level, there are health behaviours that intersect with disadvantage, and are specific to CALD that hinder participation.”

“Lower education levels and low health literacy make explaining the concept of some trials very difficult. If clinicians experience the cost or burden to be too high, they just won’t do it. They may not want to spend the extra time to do that.”

He added that there was an extremely high bar for informed consent and not enough time to allow culturally competent consent and care. There was also a broader lack of cultural competency and awareness within trial sponsors, whether they were industry or cooperative trial groups, and ethics boards.

“Sites and sponsors can take action right now by investing in this issue. This is part of a broader push for equity, diversity and inclusion in oncology services in Australia.”

“The reality is that patients from minorities do poorly at every step of healthcare and also cancer care…whether it’s screening, diagnosis, treatment, there are always inequities,” he told the limbic.

Dr Pal acknowledged some of the fixes appeared challenging such as translating trial information sheets into many languages or having sufficiently trained interpreters, particularly with a diverse but relatively small population.

He said intersectionality was also a key issue, possibly more important than language.

“So the amount of intersection with low health literacy, poverty, socioeconomic disadvantage and education is significant. And when you think about a 30-page clinical trial consent, a trial schedule with someone who’s working two jobs…I think that’s going to be an area of focus as well…if we’re really serious about trying to get equity in trials.”

“I still think America and the United Kingdom are further ahead than us in this area…just getting us back up to international practice would be wonderful.

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