Clinical Researcher—December 2021 (Volume 35, Issue 9)
I am from a diverse community, and it is important to me that my family is well represented in clinical research so we can have the best treatments and therapies available to us.
My sister has a rare disease and growing up we went through years of treatments trying to find answers. It is only now, finding myself working in the clinical research enterprise, I realize life could have been a lot easier if we had decided to participate in a clinical trial. However, at the time, we lacked the awareness or the access necessary to pursue that option.
If we can solve this challenge, we can change the trajectory of peoples’ lives for the better.
I recently discussed how we can raise awareness of clinical trials in diverse communities with Dr. Allison Matthews, CEO and founder of Community Expert Solutions, and Rashaad Galloway and Dezbee McDaniel, cofounders of CliniSpan Health. We considered the scale of the challenge, three key barriers to diversity (awareness, accessibility, and trust), and what the industry can do to help.
Diversity in clinical research is both a scientific and ethical issue. Of key importance from a scientific standpoint is the fact that study data are incomplete if diverse communities are left out.
At the moment, drugs are still being approved and reaching the market with little data for minority communities. In a review of 230 oncology clinical trials taking place between 2008 and 2018, only 145 included any information about the participant’s race. Of those that did, approximately 76% of the participants were white, 18% Black, 3% Asian, and 6% Hispanic. Without data from all of these groups, we cannot be certain a treatment works for everyone.
A 2014 study in Clinical Pharmacology & Therapeutics found variations in how people from different ethnic groups reacted to around 20% of new drugs approved between 2008 and 2013. Dr. Matthews says people of color react differently to drugs not because of inherent biological difference, but because of lived experience; for example, people of color tend to have higher rates of stress and higher exposure to environmental toxins—a key reason why they must be engaged in clinical research.
Ethically, it is our duty as an industry to work to remove disparities in healthcare, making it accessible for all. We must make sure nobody is left out.
Certain communities are extremely close-knit; their members tend to stay within the same areas, go to the same physicians, and get their information from the same places—perhaps a church or community center.
Clinical research in many areas may be confined to large teaching institutions, meaning sites like local hospitals or community centers servicing these minority populations are not asked to participate in clinical trials. Further, most patients are referred to clinical trials by a physician. If we are not reaching local hospitals, how can we hope to reach their patients?
We must build awareness on a community level to increase participation from both patients and healthy volunteers. A new obstacle on the path to such awareness is that COVID-19 has allowed everyone to recognize what a clinical trial is, but has also led to misunderstandings about the medical research process.
“A lot of people are equating medical research with” COVID-19 vaccines right now, said Dezbee. “That’s the most recent thing that has given people a reason to have mistrust, and it’s what a lot of patient conversations are centered around.”
Extensive public education has been necessary to get people to take the vaccines and explain what a clinical trial journey looks like. However, education cannot stop just because we have vaccines. If there had been more clinical trial awareness to start with, we wouldn’t have had to go to these extremes.
We need public health initiatives telling people how they can participate, how they can contribute, and how clinical trials benefit not only them but the greater good.
Even if a patient from a diverse community is referred to a trial, they will likely have to travel long distances to participate. They may have to take time off work and may not have access to the resources necessary to enroll in a study for which they are qualified.
“Research institutions are not set up in a way that makes it convenient and efficient for people of color to participate in research,” said Alison. “We need to really take a hard look at how we can do better to accommodate and make [participation] more accessible for people in the community.”
To make clinical trials truly accessible to the broadest range of people, we need to start thinking about protocol design from the everyday person’s perspective. We need to ask, is this going to be feasible? Can they participate in these visits on this frequency? If they read the protocol, will they understand what is required of them?
Addressing these considerations within protocols is the only way to make trials more accessible to these groups.
When it comes to clinical research, there are a lot of trust issues from the past, including histories of abuse within some communities. We have been naive to think these trust issues are over.
“Trust and accessibility are equally important, but trust has to come first,” said Dezbee. “It’s the rapport you build with a potential patient that leaves them open to being educated about clinical trials, and open to exploring access. Once you have built that with them, you then become partners in trying to create accessibility.”
We must make sure everyone, no matter their gender or race, receives the same treatment and standard of care everywhere. If we do not address these issues, there will not be enough trust for people to participate in clinical trials where they don’t know what the outcome is going to be.
The only way we are going to tackle trust is to make sure we are having genuine conversations with community leaders and their organizations.
Dr. Matthews said: “Make sure that you have a continued presence in the community. Don’t just come in and ask for what you need, and then leave. Be a resource for them and support their initiatives as oftentimes, they’re doing work in the community that goes unfunded and unsupported.”
This is not a problem that is going to be solved individually. We need to work together to figure out the best way forward. In this industry, we want to find solutions that are tried, tested, and true—but we must try new things because this is a problem we have not solved yet.
“One of the first things that needs to happen is the inclusion of people of color in the research process—not only as participants but as administrators and facilitators,” said Rashaad. “We need more black doctors because black people trust black doctors—people of color trust the people who look like them.”
Big pharma also needs to engage the small, grassroots organizations that are organically tackling this issue. Most of these organizations are small and localized, but they are powerful. They have the ear of the community, and they have innovative ways to reach its members.
Further, we need to make sure all clinical trials are collecting data on ethnicity. Without the data, we cannot see progress.
Finally, we must make clinical trials accessible to all sites, of all sizes.
When recruiting sites, large academic institutions are still important, but we also need to find smaller, under-the-radar sites. That might take more work, it might take an education effort, and it might take training—most of these sites have probably never participated in a clinical trial, but it will be worth it.
One Foot in Front of the Other
If we consider everything that needs to be done on a legislative and regulatory level, it can feel overwhelming. However, if we take little steps, those little steps will add together, they will result in small outcomes, and those small outcomes will result in bigger changes happening.
We cannot allow ourselves to be overwhelmed by everything that needs to be done. We need to start wherever we can. The fact we are having these discussions on an industry level is progress in the right direction.
Hopefully, five years from now, we can look back and say, “Wow, look how far we’ve come.”
LaQuinta Jernigan is Executive Vice President for The Americas with mdgroup, a global digital and patient health services company pioneering a patient-first approach to clinical research and a founding member of the Decentralized Trials and Research Alliance.