The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them
Among the many falsehoods surrounding diversity in clinical trials, the notion that people of color simply don’t want to be part of drug studies is one of the most harmful, said Quita Highsmith, Genentech’s vice president and chief diversity officer.
Following a global study the biotech giant conducted during the COVID-19 pandemic that enrolled a large majority of Black and Hispanic patients, Genentech’s latest shot across the bow for clinical diversity was a trial exclusively in patients with multiple sclerosis from those communities. Genentech sells the blockbuster MS drug Ocrevus.
Highsmith, a former PharmaVoice 100 honoree, said the trial achieved a breakthrough in proving that reaching diverse patients isn’t a detriment to the science. Black and Hispanic patients make up almost 20% of the MS population but clinical studies often fall way short of that representation, according to the company.
The problem, Highsmith said, has been that trials haven’t historically been designed to accommodate the needs of these communities. So when a trial like this one — called Chimes — meets people where they are and finds common ground with advocacy groups and clinical investigators, patients receive more equitable care.
“It’s not about doing things differently — it’s about doing different things. If we continue with the status quo, then we won’t have the opportunity to treat medically disenfranchised patients.”
Quita Highsmith
VP, chief diversity officer, Genentech
At a time when political backlash has been rising against diversity initiatives at corporations, and in education and healthcare systems, Highsmith said it’s even more important to question the status quo.
Here, Highsmith discusses the myths surrounding a lack of diversity in clinical trials, how collaboration can benefit the biopharma industry in its efforts to change and how health equity rises above political posturing.
This interview has been edited for brevity and style.
PHARMAVOICE: What are the greatest challenges to diversity in clinical trials as you see it?
QUITA HIGHSMITH: There are a lot of myths. One is that patients of color don’t want to participate in clinical research. Myth No. 2 is that, if they participate, it’s going to slow down the research, and we’re not going to be able to get the products on the market. Myth No. 3 is that patients are not going to be compliant. And these myths have meant that they have been excluded and have lower participation rates. In our research, when people of color are asked to participate, they do so at the same rate as everyone else. They want to be part of the solution. When we select sites in areas with high unmet need and populations that are going to be representative of patients of color, we’ve found that these sites are enrolling Black and Hispanic patients two times faster than other sites with the same study. If you go where the patients are and ask them to participate, they will.
These myths sound like they come from a lot of false assumptions. Can you talk about how you get past these assumptions?
One of the things we did during the pandemic was a study called Empacta, looking at hospitalized patients with COVID, and 85% of study participants came from communities of color. And what we learned was that if you go to patients, they will participate. And if you partner with sites, even if they haven’t done clinical research with us before, they are willing to work with you to overcome barriers so that you have a real-world patient population versus a fairy tale population.
Then, when we took a look at the unmet need of multiple sclerosis, we had those learnings from COVID to do this study called Chimes. The scientific question we wanted to address was that many people believed that multiple sclerosis was a disease that impacted white women. And what we know is that the epidemiology shows that Black and Hispanic patients oftentimes are disproportionately living with MS, but they’re diagnosed later. So, working with the community and Dr. Mitzi Williams, a neurologist out of Atlanta who was the lead author of the study, we were able to enroll ahead of schedule and retain those patients. And we found that safety and efficacy was the exact same as the general population, which gives organizations comfort knowing that you can bring in real-world patients to a clinical study and get a similar outcome.
With these gaps in data, how can Genentech and others in the industry use technology to improve patient diversity?
Actually, one of the areas of concern I have is artificial intelligence. The reason for that is if we look at the genome-wide sequencing database, it’s not very diverse. There’s very little data out of Africa — less than 1%. And when we think about AI using algorithms to make treatment decisions, and that algorithm doesn’t have data from people of color, we have to be very mindful that we don’t continue with the issues of the past. We’re thinking very proactively about ensuring that we have representation in the datasets we’re using. One of the things I’m excited about is the FDA’s omnibus legislation that all phase 3 programs have a diversity action plan to be considered for approval. That kind of ripple effect from the agency is going to advance opportunities to ensure patients are actually in the clinical trials.
Do you feel that Genentech’s efforts with the Empacta and Chimes studies give you a leg up with those action plans?
We’ve been working on advancing inclusive research since 2017, and as we think about the things we’ve done differently, we think about our site recruitment strategy. We think about how we engage with patient advocacy organizations, how we engage with clinical trial research organizations, and we now have in place unconscious bias training to account for study validity. I do feel like we’re better prepared to take these steps. And we’ve been writing articles and sharing it because we don’t want to hold all the secrets. We’re trying to transform society, and we have a responsibility to lead as a founder of the biotech industry.
Is there room for more collaboration in these efforts?
Absolutely. We all need to generate evidence, and a lot of startup biotech companies use the blueprint that we have because they don’t have the same resources. When we do something, it has a ripple effect across the industry.
In these politically divisive times, there’s a lot of backlash against diversity efforts. How do you promote health equity and diversity without getting caught up in the political fray?
We believe in a world where all individuals have access to the best-quality healthcare, and the work we’re doing is to include more people and be more equitable for everyone. Can anyone fault somebody for wanting to ensure people who have a disease actually have a chance to be treated? We’re not thinking about the politics of health equity. We’re thinking about how we ensure all patients have access to innovative clinical therapies and that we’re not leaving patients behind.
We’re also not blaming patients of color because they don’t have access — we’re thinking about real solutions that can address people’s concerns. It’s not about doing things differently — it’s about doing different things. If we continue with the status quo, then we won’t have the opportunity to treat medically disenfranchised patients. I have a motto that we want to treat every patient like they’re our mother, and if we do that, we’re going to find solutions.
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