equity and inclusion remain the missing links in canada’s clinical trials: 'this is a real challenge'
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when eliminating non-english speakers, visible minorities, and newcomers to canada from trials occurs, it leaves only one select group of people left to participate: well-educated, long-standing canadians with more favourable determinants of health.
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clinical trials shape patient healthcare by ensuring that the drugs and medical interventions that make it to market are generalizable and efficacious for those who need them. when the participants used in clinical trials only reflect a small number of that general population, the data becomes marred, and the clinical care people receive may not be as beneficial as the results show.
as it stands today in canada, diversity in clinical trials is nowhere near reflective of the current population, which consists of people from various demographics and ethnic backgrounds.
there is a significant overrepresentation of people belonging to the caucasian population, with visible minorities, newcomers to canada, and people who do not speak english as a first language being left out of participating in high rates. children are also rarely used in clinical trials.
unfortunately, these groups rely on medical interventions and drugs just as much as those most used in clinical trials groups, leading to them to use approved drugs that have yet to be tested in a way that shows them how the medications will respond to their unique physiology.
dr. stuart nicholls, the programme facilitator for strategy for patient-oriented research (spor) at the ottawa hospital research institute, sees these disparities first-hand and the barriers that drive them.
“i don’t think it’s a conscious decision,” he said, later continuing, “we see lots of issues in terms of just outreach to communities and awareness of clinical trials, both in the community but actually also within physicians.”
munaza jamil, a professor at mcmaster university and medical researcher, adds that additional barriers for marginalized communities perpetuate the cycle of exclusion in clinical trials, further worsening the diversity found in today’s clinical trials.
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“these (barriers) could be financial, geographic, language barriers, cultural barriers, logistical barriers that typically prevent those who are more vulnerable, those who are marginalized, to access and participate in clinical trials in an equitable way,” she said.
the barriers to equitable inclusion in clinical trials
systemically speaking, visible minorities and those in more vulnerable populations often get the short end of the stick in many regards. however, when it comes to clinical trials, the barriers in place can cause significant harm to these groups when it’s their time to seek out medications or medical interventions for acute or chronic diseases.
those in lower socioeconomic groups find it more challenging to learn about or participate in clinical trials simply because they are less affluent than others in the general population. after all, costs can be a significant factor in determining clinical trial participation, and those who make less money are often not afforded the same level of care.
patient partners who work with researchers as part of the research team instead of receiving care during a clinical trial are also an essential part of the conversation.
dr. nicholls notes that these people reflect current society and provide additional insights into how studies are designed. they also offer insights into what matters to the community so that researchers can advance their efforts in addressing the most important issues.
data from a survey conducted a couple of years ago showed that roughly 25 per cent of patient partners also cited costs as a barrier to participation.
“we know this is a real challenge,” he said.
other reasons that hinder people from select groups from participating revolve around the challenges they face in everyday life and how adding yet another thing to their plate isn’t feasible. jamil notes that newcomers to canada, especially, find it difficult to be included for various reasons.
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“newcomers to canada typically, of course, will have a challenge finding affordable housing, food security, economically, they have to look for a job. they have to find the right fit,” she said. “so logistically, that might be challenging, juggling multiple things. there might be some childcare, commutes. there might be living long distances and affording car insurance, like all of these different types of things that affect individuals who are not well settled.”
language is another considerable barrier because it costs money to have language interpreters. those with the grants often don’t want to use the money for that particular add-on, even though it is required to create data that reflects canada’s society.
dr. quynh doan, member of pediatric emergency research canada (perc), senior executive director, bc children’s hospital research institute, and associate dean, research, bc children’s hospital research institute, ubc faculty of medicine, cites language as a formidable barrier that only enables the other existing barriers to remain an issue.
“if your clinical trial does not accommodate for language barriers, then your patient selection, your participant selection is very biased towards people who are fluent in english and there are some assumptions made around these,” she said. “but these assumptions have been verified. for you to be fluent to read and write in english, you have an education, which then ties to socioeconomic status, which ties to race as well, and immigration status. so, then, who is in your trial?”
trust in the medical community is also an issue for clinical trial participation, especially among marginalized groups who have already experienced poor outcomes, discrimination, and other injustices in the healthcare system.
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jamil notes that immigrants, especially, are affected by this.
“immigrants have unique lived experiences from their country of migration, so that might have a lot of impact on how their perspectives have been shaped around clinical trials and research,” she said. “that might be going back to historical exploitation perhaps of their community, and that has fostered sort of a deep-rooted mistrust of research and medicine as a whole.”
why it’s important for clinical trial participants to reflect canada’s society
when eliminating non-english speakers, visible minorities, and newcomers to canada from trials occurs, it leaves only one select group of people left to participate: well-educated, long-standing canadians with more favourable determinants of health.
dr. doan notes that when people in good health standing are the only ones included in clinical trials, the data on the drug in question isn’t going to reflect how it works in a general population.
“(if) you’re looking at a more favourable group of participants with more favourable socio-determinants of health, what that does is they were going to fare better anyways,” she said, citing that the drugs were always going to do better in that group because they were primed for it.
however, they are not the only people who will need a specific medication; thus, not including those who don’t belong to that same group but will be getting the same prescription may not get the same results.
“when the results come out, they only apply to people like that who have access to healthcare and access to the system who are rather savvy at navigating the healthcare system,” she said.
she continued, “so if a treatment requires that you are able to attend clinics for follow-up that you reach out if side effects occur, and you only include people who are able to get themselves to clinics and who also already know how to access those clinics and when to access urgent care. then, the people who don’t might not do so well with that treatment. but you didn’t capture that.”
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essentially, data garnered from incomplete trials or trials that do not reflect the current general population will, in and of itself, be incomplete.
according to statistics canada, by 2041, roughly 34 per cent of all canadians will be foreign-born as immigrants continue coming to canada. to reflect the new society, clinical trial holders and those in the medical research sector must change how they do things if they want their data to apply to the population.
“it’s really important to bring this population in and to hear the voices of newcomers to canada in general, promoting diversity and inclusivity of different groups,” said jamil.
she continues, “it’s really important to embed these in clinical trials because it’s what makes the results of the trials generalizable. it makes sure that the results of your trial are going to be safe and effective in all groups because you actually tested them out in different groups, right?”
what’s being done to change the tides
medical researchers, including dr. nicholls, jamil, and dr. doan, are just three of the many canadian research professionals who have used their voices and their work to perpetuate more inclusivity in clinical trials.
dr. nicholls understands that the barriers will be tough to climb, but there are ways around the obstacles to equitable inclusion. one of the first is developing infrastructure that supports inclusion from the start. he notes that bringing clinical trials into areas not currently served can make a massive difference in that infrastructure issue – as long as it can be done permanently.
“i think going forward, if we can be innovative and try to and build that infrastructure so we have it permanently, we’re not rebuilding it, then that can really help,” he said. “and again, if we can couple that with bringing other areas, other communities into clinical trials, i think that’s a real benefit, potentially anyway, going forward to try and improve inclusion in clinical trials.”
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jamil believes that to make any real, lasting change, awareness and education – which start with open and honest conversations that acknowledge the issue – are needed going forward.
“that’s really, really important in this day and age is for research teams to invest in cultural competence training for their teams. so, cultural competency is not a one-time achievement. it’s not like you can get a training and you’re certified to be culturally competent,” she said. “it’s a process of learning. it’s a journey you take. it starts with self-reflection.”
n2 canada: a national initiative was established 15 years ago to help ensure high-quality research that embraces inclusion and diversity. jamil, the co-chair of n2 canada’s public engagement committee, believes this initiative and others like it are the way forward toward total equity in clinical trials in canada.
“n2 can actually create this collaborative environment of all of the interest holders to come together and to work on ways that we can collectively promote health equity in clinical trials,” she said.
dr. doan notes that the exclusion of these minority groups has only continued because people fail to stand up for issues when it doesn’t directly apply to them – and that has to change.
“the problem is that culturally, we as a society accept the incompleteness because it affects the marginalized groups. we don’t stand up and voice that concern for the marginalized group. it still suits most of us who are fluent in english, who have access to care, who are educated,” she said. “there is not an incentive for people who have a voice to speak up for the marginalized group, and it’s a vicious cycle.”
essentially, people need to care more about those marginalized groups, even if it doesn’t directly affect them, to create a more inclusive and diverse clinical trial environment.
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dr. doan and her colleagues have done their jobs at fostering a more inclusive environment for those with language barriers by providing interpreters and translators free of charge and creating a guidebook that states the risks of exclusion and how to foster more diversity through a language pilot project. dr. doan hopes this will show in as clear a way as possible that diversity and equity in clinical trials are the only way forward in clinical research.
“what i’m hoping is that if we demonstrate that this is feasible and this actually does increase diversity, people use it, and it works well, is to bring this and advocate at government funding agencies so that they honour that,” she said.
at the end of the day, the conversation and awareness of the issue will foster positive changes as long as medical researchers continue to work toward more inclusive and diverse patient populations.
“we’re talking about it. we are raising awareness,” said dr. doan. “even down to a conversation, to be able to recognize when the conversation is stigmatizing, is prejudice, is limiting, is not inclusive … to bring it up and challenge that status quo, and in normalizing this work, eventually it will translate into the way we ask our politicians for accountability. the way we vote. the way we make decisions, the way we do business. then, most importantly, the way we treat each other.”
this discussion was recently presented at clinical trials ontario’s cto conference on november 6 and 7, 2024.
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