Beyond technology, awareness and access, cultural competence is key.
Our Scott Schliebner, senior vice president of the Center for Rare Diseases, recently had a conversation with Christian Rubio, vice president of strategic advancement at Global Genes, the rare disease patient advocacy organization, tackling questions about the implications of the lack of diversity in clinical trials, how that impacts health equity, and how cultural competence can help close the gap.
Unfortunately, very few eligible participants are aware of, and participate in, relevant clinical trials. In addition, the demographics of those participants are skewed in comparison to any given population. For example, although Black Americans make up about 13% of the U.S. population, Latinos about 18%, and Asians more than 5%, those demographics aren’t reflected in clinical research. The FDA reports that only 5% of clinical trial participants are Black, fewer than 2% are Asian, and fewer than 1% are Latino. And it’s not only race; women and seniors, for example, are also poorly represented.
The lack of diversity isn’t just a moral issue — it is also an issue that has scientific and global health implications. The long-standing systemic health and social inequities that result in uneven representation in clinical research mean that today’s medicines may not be equally safe and effective for all populations, leading to a health equity chasm that must be addressed.
Finding a solution isn’t easy. In fact, one hurdle to correcting the problem is determining what the disparity is in the first place: In a study published in JAMA Oncology, of the 230 oncology clinical drug trials between 2008–2018 that resulted in approved cancer drugs, only half included any information about the participant’s race. And of those that did report, the breakdown was vaguely defined.
So, what can be done? Scott and Christian explored:
What are the complications and challenges specific to working with rare disease patients because of a lack of diversity in research?
Scott: There are many rare genetic disorders that occur in certain populations that don’t occur equally among ethnicities or across different geographies. That means without diversity in the clinical development stage, we could be developing new therapies that might not be effective or applicable to many of the key populations that hope to benefit from that therapy at a later time.
Christian: Also, there may be inherent bias in how we’re defining ethnic components of rare disease simply because of who has been studied, and there may be greater prevalence than we previously thought, so the bias could actually be in how it’s being looked at in the first place. This creates a vicious loop, a circular logic, in which the people we use in our imagery and the marketing channels we choose for patient recruitment will also be biased by the known data.
Scott: In fairness, it is very hard in the rare disease space. Suppose we’re running a Phase II clinical trial in a rare neurodegenerative disorder. The challenges inherent in rare diseases make running those trials difficult to begin with and finding those specific rare patients and enrolling them in a clinical trial in a timely manner is tough. If you also overlay the desire to incorporate an ethnically diverse patient population, not only are we saying, “Let’s find those very rare patients,” but, “Let’s also make sure we have 10 percent Black and 30 percent white and 10 percent Asian.” Now you’re looking for needles in a haystack and some of that would be nearly impossible in some settings. Not saying we shouldn’t try — but in some settings that’s a high bar and it’s partly why we are where we are now.
Christian: That’s why for rare research, we have to be students of community engagement from well-funded prevalent disease groups — identifying what’s worked in oncology or diabetes, for example, and understanding social determinants of health. It’s essential to do this because of the small patient populations we have in rare disease – every single patient counts toward the research, and increasingly, our communities are called upon to be engagement partners to help ensure studies have representative participation.
What needs to happen to achieve diversity in clinical research from a process perspective?
Scott: We need to tackle any barriers head-on! Whether it’s creating awareness, reducing patient burden, building trust, educating patients, getting research into patient community care, or using technology to minimize geographic barriers, we need to be compassionate to what the patients’ challenges are and find ways to meet them where they are. Wherever that may be.
Christian: When we think about innovation, trial design, and what needs to be done to achieve diversity, all the solutions need to be centered around human connections — our networks and keeping people connected. We need to start by thinking about who we’re trying to engage and how. It’s the perfect opportunity to start thinking about how to do that while also increasing opportunity for diversity, equity, and inclusion.
Scott: Using technology isn’t the entire solution, but it is a start. Technology helps us reach populations that we might not have access to otherwise. But we need to really be aware of what you’re asking people to do and make it easier for them and realistic for them and their families. Technology is a piece, but it definitely starts with a mental shift in thinking about patients first and going from there. Letting their needs shape how we approach the study and catering our solution to what works for them.
Christian: And when we consider solutions like telemedicine from the lens of diversity, equity, and inclusion, we need to keep in mind that it’s a great example of one solution not solving every problem. For instance, technology that isn’t very simple can be a barrier for older patients, so that possibly limits their inclusion. Or, for rural populations, telemedicine gives them access, but if there’s even a small amount of travel, you may still be limiting participation because of that.
What needs to happen from an overall research industry perspective?
Scott: We need to move away from the way things have “always been done” and reframe our thinking. For the past 20 years or so, patient recruitment has not been about partnering with communities or building trust with patients, it’s been more about filling clinical trial quotas on time and on budget. It’s been very transactional; not about building relationships at all. To make real change, we need to partner with people and consider potential clinical trial participants as true stakeholders in the clinical development process.
A lot of this gets down to determining how to take a new potential therapy and ensure there is broad awareness and access. This means that we most likely will not proceed down the traditional patient recruitment method that results in a homogenized participant population, but rather find a way to create awareness in a new way to reach a broader audience and engage communities that are more diverse. To do that in a way that’s long term, you really need to focus on relationship building.
Christian: We’re working with the Black Women’s Health Imperative to study the diagnostic odyssey of minorities and underserved communities in rare diseases. Part of our work is to understand the gaps and develop programs to break down the siloes between centers of excellence and other local institutions, especially historically black colleges and universities. Our communities need more integrated care and research, and government agencies, NGOs, and industry-funded research can help incentivize these more collaborative, integrated research network models.
Scott: That definitely comes from the top down. Not only within any given organization, but if you think about the regulators, and the FDA specifically, they’re encouraging drug developers to collect data in more of a real world environment; continuous data instead of data collected every two months when participants visit a clinic or hospital in a traditional clinical trial model. A more modern and progressive approach allows for increased access, opening the door for inclusion, and allows people to participate remotely and collect data in a real-world environment, moving us out of the artificial clinical environment into a truly consumer-friendly, patient-centric world. That alone doesn’t guarantee equal access to different groups and people and backgrounds, but it’s a step in the right direction.
How do cultural competence and personal bias factor into building those necessary community connections?
Scott: Let’s face it, because of some horrific historical events, there’s cultural distrust within some communities regarding the medical profession. So, we need to think about how we begin to repair these relationships, have authentic conversations the right way, with the right sensitivities, and rebuild trust.
Christian: That’s right. We have to really turn the focus on ourselves and say, “How do we teach ourselves sensitivity and truly understand to see through the lens of a particular patient community that is not like us?” We need to build straight-up trust with these communities. Having uncomfortable conversations that force us to listen and really hear a community’s concerns and experiences in their own words is the only place to start.
Scott: Once that’s in place, we need people to invest up front with community building; creating education and awareness in those communities so when a trial opens, you already have those trusted relationships and can have a much more sincere approach to connecting with those patients. We need to be reaching out more broadly and amplifying our message to populations it would be relevant for.
Christian: We’re studying what’s been done with community health workers to bring medicine, wellness checks, and education to underserved patients to guide new partnerships with health community organizations and teams. They’ve been able to act as “rare disease scouts” and do more disease surveillance to broaden and flatten the access of the playing field to find patients.
How can we, as individual members of the clinical research community, take steps toward achieving the cultural competence that leads to diversity in clinical trials?
Scott: We need to make proactive investments in understanding and building trust in various communities, find a unified approach, and keep asking ourselves what we can do to reform this system.
Christian: Right. And one thing we can do is strive for connectedness throughout healthcare. Because if you don’t have diagnoses, you don’t have patients to recruit for a trial. Connecting the dots between communities and centers of excellence, for example. Building these networks is essential to creating an equitable system. We need to embrace the fact that all of us in this industry need to play our part — manufacturers, patient advocacy organizations, caregivers, patients, payers, regulators … we have to understand we’re part of a national challenge together and have discussions and come together to start that dialog.
It’s about having a very intentional approach. And everyone can start in their own circle. Look at your own community. Ask questions, seek new people to talk to and get perspectives. If someone knows a lot about an underserved community, even if they’re not in your therapeutic area, you’re going to learn a lot talking to them.
Researchers need to take personal responsibility for growth and awareness and ask questions of new people. That takes bravery. You have to know you’re going to come across as naïve, but that’s okay. That’s how you learn.
Scott: Absolutely. To build trust within underserved communities, come in asking how you can help. Ask how you can learn. Even flat out ask, “What can I do to learn from you?” That’s a great way to start — these communities know more about themselves than we can even grasp.
Christian: I agree. Ask community leaders you partner with what programs they run, even if it’s a church lunch program, to understand what people value in a community. Ask what galvanizes community, and how you can be part of it. Develop your cultural competence as an individual and then apply that to your research work.
And there’s one more side of the research dynamic to consider. We have to ask ourselves the tough questions about our work environments, too. Is our research team diverse in ethnicity, academic pedigree, and home community experience? Do we hear their experiences in our internal discussions? Do their experiences and backgrounds get incorporated to foster better connections with community leaders? Is that valued by leadership? When we demonstrate openness by asking questions, we show our willingness to challenge our assumptions inside and outside the research conversation, and that builds trust with better engagement as the metric. That’s how we’ll close the gap in diversity in clinical research. It won’t come quickly, but we have to start.
Neurodiversity in the Workplace: Promoting Inclusion and Understanding of Autism
While we look for new ways to treat different symptoms associated with autism, we must also find better ways to accommodate and understand people…
Human Centricity Sell Sheet
Sell Sheet containing the business benefit, programs, and competencies.
Shining a Spotlight on Down Syndrome Through Education, Advocacy, and Research
Learn the facts about Down syndrome, advocacy and research for this condition, and the neurodiversity movement.