The matter of trial diversity has become a prominent and much talked about topic in clinical research circles. After decades of the problem being largely ignored, the needle is starting to move, albeit slowly.
The issue has seen renewed interest during the Covid-19 pandemic, which saw the launch of hundreds of clinical trials around the world testing potential vaccines and drugs against the novel SARS-COV-2 virus. Without real-world representation, it’s difficult to know how well a therapy might work in certain populations or if it might pose an additional risk to a particular pool of patients – a threat that looms ever larger amid the rush of clinical testing during a pandemic.
In a recent JAMA Network Open study, researchers used data from completed US-based interventional vaccine trials from July 2011 to June 2020. Among adult study participants, white individuals were overrepresented (77.9% of participants whose ethnicity was known) in clinical trials when compared to census data. In the same set of trials, Black or African American individuals accounted for only 10.6% of participants and Hispanic or Latino participants 11.6% – both were underrepresented based on their percentage of the US population as a whole. The study presents comparable statistics showing the underrepresentation of Asian, American Indian and Alaska Native participants.
Clinical research and minority groups: a history of distrust
Coupled with the lack of active recruitment of diverse participants, the problem is exacerbated by the deep-rooted lack of trust that some communities (especially communities of colour) have in the healthcare and pharma industries.
“Classically there’s a whole history of abuses of power in clinical research amongst minority populations, leading to layers of mistrust,” says scientist turned science communicator Paige Brown Jarreau.
Jarreau is the VP of science communication at LifeOmic and the co-founder of Lifeology, a platform that combines art with science to create accessible stories to educate people around research, health and clinical trials.
“That’s very difficult to overcome if you’re not actively trying,” Jarreau continued. “A lot of clinical trials historically have focused on white men just because it’s easier to. There’s more data around their background, but the data that comes out is not useful if you’re not having diverse populations participating.”
“Gaining that trust back is often painted as helping people trust science again, as opposed to presenting science as more trustworthy.”
The Covid-19 pandemic has shone a very public spotlight on clinical research and drug development, prompting deep divisions along pro-vax/anti-vax lines. Jarreau explains that while this renewed public interest around how vaccines work and how scientists study viruses is a positive, it does not conquer the issues that were always there – “of scientists often speaking top-down, presenting information as if it’s gospel, not involving people in the research and being transparent about it ahead of time”.
“There have been issues regarding diverse participation for a long time and when it came to the pandemic, there was a greater impact of Covid-19 amongst communities of colour,” she adds. “Early on for that not to be acknowledged or focused on immediately including with the vaccine rollout, I think that brought about increased mistrust or more emotions around scientists and healthcare professionals not looking after certain communities. I think some of that was corrected as we went, but it wasn’t enough.”
“Vaccine hesitancy and the issue of not participating in clinical trials is often put on the audience instead of realising that it’s not on them, it’s on the scientific community and things we’ve done wrong in the past. We need to show how it’s different now and how they’re going to be protected.”
Art’s potential to fight ‘infodemics’
Lifeology’s mission is to help tackle ‘infodemics’ by connecting communities, artists and scientists to create visual flashcard courses as educational materials.
The World Health Organization (WHO) defines an infodemic as too much information, including false or misleading information, in digital and physical environments during a disease outbreak – something that has become all too familiar during the Covid-19 pandemic.
For those communities and individuals already mistrusting of the healthcare industry, this information overload can be distressing, confusing and alienating.
“I think in this era of overabundant information, where people are struggling to find the answers they need and information that’s trustworthy, there’s a lot of potential for new forms of communication that can touch broader audiences. You need lots of different formats because we literally need to speak to everyone,” explains Jarreau.
“Science is often presented as text and jargon, which can be very intimidating for people. Bringing it into the world of a visual story allows people to feel like they can understand and even come to their own conclusions or opinions. Storytelling with visuals dates all the way back to when we were drawing on cave walls. There is a long history of people communicating with each other through visuals and stories. I think it’s just something that we crave from others.”
Empathising with communities
When dealing with communities that have historic mistrust in healthcare, Jarreau highlights empathy as a key skill and thus, one of Lifeology’s courses for health professionals focuses on being an empathetic science communicator.
“It’s really the only way to go about communicating in these instances where there has been mistrust and misinformation,” she says. “You have to have empathy to truly engage these audiences. Otherwise, you might make people feel like they’re doing something wrong, or that they’re wrong in that mistrust of the scientific community without the scientific community showing how they can be trusted. That’s not the right way to go about making people feel like equal partners in clinical research.”
Empathy should also be the guiding principle when engaging those who are suspicious of vaccines, Jarreau says – as others have argued, a top-down, prescriptive approach may shore up resistance rather than help to dissipate it.
“You can’t just tell people they are wrong for not getting a vaccine. That’s not going to work and you’re probably just going to turn them away. So having empathy and really trying to get to the root of what’s beneath that reason for not wanting to get the vaccine – that’s really the only way to engage people and to help them surmount those prior beliefs or misinformation that they might be clinging on to.”
Collaborating with artists, communities and pharma
Lifeology is now working with major pharma players like Eli Lilly to help bring information around science, health and clinical trials to people in a different way.
Eli Lilly reached out to Lifeology looking to create educational materials around clinical trials to help recruit Black, LatinX and Native American participants.
“The Lifeology format and the way that we create courses allowed us to come in and work very collaboratively to produce these visual stories that could speak to these different audiences,” Jarreau says. “One of the key ways that we did that is involving people from these communities from the start. We can’t create a course for Native Americans participating in clinical trials without talking to some Native American audiences and organisations that work in this space and asking them questions about their barriers to participation and things like how these communities would get from their locations to a clinical trial site.”
Learning about these communities and their needs and then working with diverse artists and storytellers in these spaces allows Lifeology to create more relatable stories that educate people around what clinical trials are and the need for diversity in clinical trials.
There are many barriers to recruitment and retention of communities of colour within clinical trials, and Jarreau knows this education is not going to address them all. But it starts the conversation, she argues, allowing people to learn more about clinical research and some of the questions they should be asking or thinking about when a doctor approaches them about a clinical trial.
“If people don’t see themselves represented, it’s going to be a lot harder for them to trust that this process is going to treat them fairly, have their best interest in mind and isn’t just trying to seek representation in a way that would put their communities at risk or hurt them,” Jarreau says.
“Creating materials where people can see themselves, their communities and culture reflected, helps them feel embraced, heard and like they are going to be taken care of if they do sign up in a clinical trial. In these educational materials, we try really hard to acknowledge past traumas and trust issues and talk about the protections that are there today for anyone who participates in a clinical trial so they feel they can be a part of this process in a way that’s fair and ethical.”