Racially diverse clinical trials: A new patient-led legacy takes root

Attempts to make trials more diverse aren’t working. To overcome far-reaching inequality and deep distrust, pharma must be educated by, as well as educate, under-served communities

The differing health outcomes from COVID-19, depending on sufferers’ ethnic background, is a salutary reminder of the uneven, and often downright unfair, experience of some ethnic groups when it comes to healthcare.
It further underlines pharma’s need to do better to make clinical trials more racially diverse and so improve the efficacy of medicines for these under-served groups, and in particular people of Black, Asian and minority ethnicity (BAME).
This is by no means a new problem and, to put it bluntly, pharma’s approach so far hasn’t worked.
There are many reasons for the lack of representation of BAME people in trials. An important one that pharma must acknowledge and work to address is a lack of trust owing to poorly or unethically conducted trials in the past in developing nations, says Kunal Patel, Medical Director, of medical education group iheed.
“Word spreads fast when you're found to be unethical in these regions, it has a long-lasting legacy effect,” says Patel. “It has left a shadow of suspicion, which makes recruiting for trials today harder.”
There are other big issues as well as that of trust. Starkly differing levels of access to healthcare, particularly in the US and low representation of BAME people in medicine and science are structural inequities that will take time to redress.
Barriers to participation
But a range of other practical barriers are much more amenable to solutions today. These include financial and related costs of participating in trials, which are disproportionately issues that BAME people face, says Maimah Karmo, breast cancer survivor and Founder and CEO of the global patient advocacy organization, Tigerlily Foundation. “Leaving your job to go to a trial, travel time, day care and leaving an hourly wage job to go. Those things are important barriers to consider and address.”
Other reasons for the lack of participation among BAME and other ‘minority’ communities is simply that they are not asked, or if they are, they lack an understanding of the trial process. And part of the reason for this lack of understanding is the alienating communications approach, language used and the fear of the words “clinical” and “trials”, adds Karmo.
“The language used around these things is scary.  We spend too much time talking amongst ourselves, so these terminologies are more comfortable for us, but for people who don’t have an understanding of the power of clinical trials, paired with medical mistrust, is a major barrier.  One thing we've done with Tigerlily Foundation lately is we're going to our patients are we're asking: what do you understand about clinical trials? And we talk with them in their language.”
The use of some terminology is worth re-considering and perhaps discontinuing. For instance, the use of the term ‘minorities’ does a disservice to groups that are fast becoming anything but. Black and Latino people are among the highest populations of this country, but they're marketed to as minorities. says Elizabeth George, Director, Clinical Trials Diversity, GlaxoSmithKline. “We need to change our vernacular around clinical trials and around minority populations.”
Access to trial centers, which are often far from BAME and other under-served communities, is another practical issue to address, says George. “There's a tendency to go with the larger research institutions because they have the experience of working with clinical trials and a lot of the smaller sites don't necessarily have the infrastructure to support the specific needs of a clinical trial.”
Given the multifaceted nature of the problem, pharma needs a whole new approach that is patient-first and which addresses the most pressing geographic, communications and trust problems all at once. Partnering with patient advocacy groups and diverse PIs as well as doing community outreach is important to build trust and extend the reach of clinical trials to more diverse patients, says George.
An army of angels
Trusted patient advocacy groups partnering with patient advocacy groups is key to this, says Karmo. “I think engaging patient advocacy groups that are Black led is important. Bring the patient to the table as an equal partner. An equal partnership means investing in their education, in advocacy and empowerment, in understanding how to make terms culturally literate for them.”
Patient groups can inform their clinical partners of how the patient wants to be treated as well as build an appreciation among patients of how the process works in practice. Karmo cites the work Tigerlily has done to build an “Army of Angels, of women that are African-American, some Asian, different brown skinned women, but they're trusted by their patients and they're coming to us for advice. This is my passion and I think the model is really hot and its working!”
Help can be precisely targeted to where it is most needed with this approach, adds Karmo. “There are 20 cities that have the highest rate of Black women dying of breast cancer. So, we've invested time and money in going to those communities, learning from the advocates and creating solutions to understanding to health literacy, asking you about financial barriers and so forth.”
Another issue is the distance many communities are from trial locations. The answer is to bring trials closer to the communities that aren’t being served, including funding trials in smaller hospitals that normally lack the required resources, says Kelly McKee, Senior Director, Patient Recruitment and Registries for Medidata Solutions. “We need to make it easier for people to participate and we also need to make those experiences really good. How do we bring the big hospitals to the small communities?”
The integrated research organization (IRO) is a useful model of how trials can be brought closer to under-served communities, says Irfan Khan, CEO of clinical trials platform Circuit Clinical. “I personally think the federally qualified health centers are fascinating because they serve these populations very selflessly and they're really focused on providing the same kind of care.”
Technology, such as myMedidata, a patient portal allowing patients to participate in their clinical trial activity virtually, along with new ways of working that have exploded as a result of working practices adopted during the pandemic can also help address the issues of time and resource constraints faced by these communities, adds McKee. 
“Not everybody has an extra 10 days of vacation and sometimes they'll travel for a long distance, only to be seen by the investigator for ten minutes and then have a couple of blood draws. These can be done at home very easily with a home health nurse and you still have that experience with your physician through the telemedicine video visit.”
Imposing solutions is not the answer, however, and it is best to find out from patients what sorts of approaches work for them, adds McKee. “If we allow patients to have a say in the type of experience that they want to have in a clinical trial, we're going to make clinical trials an option for more people.”
Patients as teachers
Indeed, the paradigm that patients need to be educated about trials should also be inverted. Clinical and pharma people have much to learn from patients when it comes to trial design, says Karmo. “Have the patient help you create the solution. We're building a training program right now that patients are creating for the providers, so we're training researchers and scientists, training the health care provider, nurse, navigator."
A good example of this two-way process was when Tigerlily took twenty five women of colour to the San Antonio Breast Cancer Symposium. “They got to understand how to talk to scientists, how to ask the right questions. How to become partners in designing treatments, looking at what's working, what's not working. When you start off getting the patient educated, empowered, informed and as a partner at the beginning of the process, you have a relationship that evolves.”
Such engagement also serves to build trust with under-served communities, adds George. “Having those relationships established means that when there is a need to participate in a clinical trial, it isn't looked upon with caution or suspicion.”
Internally, pharma must also ensure the drive to widen participation is established internally, says George. “Having a diversity champion on the study really makes a difference. At GSK we have an amazing team of individuals who are passionate about clinical trial diversity that are working across the enterprise on this effort. The sponsorship and the commitment from senior leadership is also really critical in moving things within a large organization.”
There is now a discernible change in the attitudes of clinical trials stakeholders to finally make a difference and build bridges, says Karmo. “I've never seen so much interest in clinical trial engagement and for the Black community. And so, now's the time to change how we're approaching things, find new solutions and change the legacy of clinical trials for Black people.”
“We need to change it. I think it's time, I know it's time, that we go to the patients to show us how it's done because we haven't been able to figure this out on our own.”