To better understand how medications impact the people who use them, participants in clinical trials should reflect real-life demographics. And yet, a U.S. Food and Drug Administration (FDA) analysis of clinical trials in 2020 found participants were largely homogenous and unrepresentative of the populations the healthcare industry serves: globally, 76% of enrolled participants were white, while just 11% were Asian and 7% were Black.1 In the United States, 78% of enrolled participants were white while roughly 22% were people of color,1 despite having a population nearly twice that number.2
These disparities could potentially hinder healthcare, says Angel Akinbinu, who is director for site and patient diversity with Syneos Health®. “When we do not have diversity in our trials, we run the risk of medications going to market without us knowing how effective they are in different patient populations,” she says. “It’s a major gap for the industry.”
As scientists, policy makers and business leaders continue to reflect on how the COVID-19 pandemic disproportionately impacted communities of color, important conversations are taking place around closing that diversity gap. Earlier this year, the FDA issued draft guidance to expand trial representation,3 and pharmaceutical companies have been making commitments to be more inclusive in their research. Akinbinu says those are important steps that make her hopeful. “The FDA draft guidance really lit a fire in the industry. They are imploring us to move beyond reactive strategies and be intentional about diversity from our earliest clinical trial designs,” she says. “It’s not about ‘Do we want to include diversity in our trial?’ We are running a trial so we should treat diversity as we do any other essential element.”
In order to design clinical trials in which participants more closely reflect real-world demographics, Akinbinu says sponsors must do more than simply set goals; they must also measure their progress and hold themselves accountable. Doing so, she says, can reveal better understandings about drugs, and also build trust in communities that have long been underserved.
To help keep the current momentum to diversity going, Akinbinu shared five steps that pharmaceutical enterprises can take to improve representation in trials, for the betterment of science.
- Change must start within the organization. Placing a value on diversity may require a cultural shift, and that’s something that takes time, effort and buy-in at all levels of an organization, says Akinbinu. Education and training can raise awareness of what clinical trial diversity means, why it’s important and what each person can do in their role to help. “Everyone needs to see themselves as part of the process and as an ambassador to improving clinical trial diversity,” she says. “Taking the time to educate employees is ultimately going to give you buy-in because they will get it and see that it’s the right thing to do.”
- Engage the community early. Enrolling participants in a trial takes trust, and that takes time to build. “It's imperative that we don't wait until we have a trial and we're looking for patients to enroll,” says Akinbinu. Instead, get to know people by hosting educational events. “We should be going into communities and talking to people about the diseases that are more prevalent in their community, talking to them about clinical research we’re doing and how clinical trials can be an option in their healthcare journey,” she says. Then, when a company is actually enrolling for a trial, the trust from the community will already exist.
- Educate healthcare providers about trial opportunities. Patients trust their doctors and look to them for medical advice; yet busy doctors don’t always know about the latest clinical trials. By informing those healthcare providers about research that’s applicable to their patient population, they can, in turn, educate patients about clinical trial opportunities that could help. “We have to recognize that in many instances, local healthcare providers are the gateway to the underrepresented patient populations,” says Akinbinu.
- Bring new sites into your network. Often, clinical trials take place in established academic medical centers and large hospital systems. But those aren’t necessarily the places underrepresented patient populations go, says Akinbinu. Bringing in new sites—such as primary care doctors, clinics and community health centers—could also bring in new participants. “We cannot continue to go to the same sites and expect that we're going to see different results,” says Akinbinu. “We have to find a way to bring in sites that are actually treating the patient populations we’re looking to enroll.”
- Work with a trusted partner to devise a diversity strategy. Every pharmaceutical company is balancing their own unique challenges. Some have been building their diversity strategy for years, while others are in the early stages of doing so. Working with an external partner can help at any stage, says Akinbinu, from establishing a clinical trial strategy to refining one, or even working to devise an internal diversity strategy. For her part, Akinbinu’s team at Syneos Health excels at all stages of inclusive planning, from design, site selection and recruitment, all the way to devising a marketing strategy once a therapy has been approved. “Having worked in this space the way we do, we’ve been able to see the strategies that work, and the pitfalls to avoid,” she says.
The pandemic shined a light on the importance of diversity in clinical trials. Now, Akinbinu says, pharmaceutical companies must build on their commitments, or they risk alienating entire patient populations.
“You can't just show up in a community when you need them and then disappear. If we as an industry do not continue to build on that trust, and we go back to the way we were before COVID-19, my concern is that the progress that we made in clinical trials through the pandemic will be lost,” she says.
Diversity, says Akinbinu, shouldn’t be considered an add-on, or “a nice-to-have.” Moving forward, it is imperative.
To learn more about how Syneos Health can help your team devise a diversity strategy, visit www.syneoshealth.com.
- U.S. Food & Drug Administration. “2015-2019 Drug Trials Snapshots: Summary Report.” https://www.fda.gov/media/143592/download. Nov. 2020. Accessed Nov. 2, 2022.
- U.S. Census Bureau. “The Chance That Two People Chosen at Random Are of Different Race or Ethnicity Groups Has Increased Since 2010.” https://www.census.gov/library/stories/2021/08/2020-united-states-population-more-racially-ethnically-diverse-than-2010.html. Aug. 12, 2021. Accessed Nov. 2, 2022.
- U.S. Food and Drug Administration. “Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry: Draft Guidance.” https://www.fda.gov/media/157635/download. April 2022. Accessed Nov 2, 2022.