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Clinical trial diversity is the cornerstone of equal access to care, but clinical trial participants are still overwhelmingly white.
Data released by the Food and Drug Administration (FDA) in 2020 found that, of 292,537 global clinical trial participants, 76% were white, 11% were Asian and 7% were Black. An analysis in Nature noted how poorly this correlates with the actual world population: “~60% of the population in Asia, ~16% in Africa, ~10% in Europe and ~8% in Latin America.”
More diverse clinical trials are good for everyone. They make the healthcare landscape more transparent, they advance new medical discoveries and they improve healthcare infrastructures globally. The first step to addressing the problem is opening up access and starting conversations with diverse communities around how drugs and treatments are developed.
As the Biotechnology Innovation Organization (BIO) reported in November 2021, the lack of diversity in clinical trials is not due to a lack of interest among diverse groups, but a lack of access and engagement among minority populations.
For example, BIO reported, a survey found Hispanics are more eager than non-Hispanic whites to participate in trials, according to Adolph Falcon, Executive Vice President for the National Alliance for Hispanic Health. The same survey found that “the number-one reason Hispanics are not participating in clinical trials is ‘I was not asked,’” he said.
A report by the biotechnology firm Amgen highlighted, “Clinical trials have lacked diversity for decades and many believe this issue is rooted deeply in the history of abuse and neglect toward minority communities—and the Black community notably—dating back to the era of slavery.”
“I think there’s a lot of judgment and paternalism in the healthcare system,” Dr. Lisa Fitzpatrick said in an episode of the I am BIO podcast that looked at the lack of clinical trial diversity. “We make decisions about who we think are optimal candidates for participation in research trials, or we make judgments about whether or not we think people can follow through and actually never give them the opportunity to say yes or no or ask for support to be in a clinical trial.”
Ultimately, it is up to the healthcare industry to prioritize clinical trial diversity through outreach. It is the equitable thing to do, but it is also the best way to ensure clinical trials capture reality. “Inclusion is not only a social goal,” Falcon told BIO. “Inclusion really goes to the core of good science and well-run clinical trials.”
As we celebrate Clinical Trials Day today, it is key that we discuss not only the continued need for clinical trial diversity, but also what is being done to meet that need.
How is biotech diversifying clinical trials?
More and more biotech companies, as well as healthcare nonprofits, are prioritizing and building the infrastructure around diversified clinical trials. For the industry’s part, companies like Genentech, Biogen, and Amgen are all prioritizing increased clinical trial diversity.
Gerren Wilson, the former head of inclusion strategy and partnerships within the chief diversity office at Genentech, told the I am BIO podcast that Genentech prioritized clinical trial diversity in the wake of the COVID-19 pandemic.
“It is important to be directly focused on unlocking the power of diversity and inclusion,” Wilson said. “Just look at the next 30 years. By 2030, new cancer cases will increase by over 80% in low-income countries. By 2040, over half of patients with Alzheimer’s in the U.S. will be Black or Hispanic. Within five years, those cases are predicted to increase by 2% in Black patients, 98% in Latino patients, and 120% in patients of Asian and Pacific Islander ancestry. … Mental health organizations are not treating those patients now. We won’t be in a position to provide them the care we aspire to if we don’t change immediately.”
Genentech is responding to the challenge by establishing the infrastructure for change—creating an external counsel and advisory body to provide the company with recommendations for change and act as an accountability body. One effort Wilson highlighted is Genentech’s “zero cost of patient initiative, which is really looking at some of the ancillary costs that are associated with research, more frequent doctor’s visits, which require, you know, transportation costs, childcare costs, things along those lines.”
Amgen is improving trial diversity through an internal program known as RISE (Representation in Clinical Research), founded in October 2020. The program was started as a result of a paper, “Increasing the Diversity of Subjects and Investigators in Amgen Clinical Trials,” by Racquel Racadio, according to Amgen. RISE was created with the stated purpose of making sure Amgen prioritizes and improves access to clinical trials.
“The RISE team will work with the Global Development Operations organization and other key groups by diversifying investigators and collaborating with those who serve diverse patient areas at clinical trial sites,” Amgen said. “They will also work with nonprofits in communities that can help remove barriers to participation in clinical trials.”
Biogen, for its part, initiated a collaboration with Tufts Center for the Study of Drug Development with the goal of access for all citizens to clinical trials. “But delivering on that goal takes a commitment to understanding deeply who patients are, their needs, and how we can best support positive health outcomes,” Biogen said in a press release. “We need to start at the beginning and build into every decision we make and step we take the diverse socio economic and individual health considerations of each person we encounter.”
How the biotech industry is improving clinical trial diversity
In November 2021 BIO launched the Clinical Trials: The Power of Participation (CTPoP) website, which “addresses how clinical trials work, how to enroll in a clinical trial, and what to expect as a clinical trial participant with sound, science-based information.”
“Knowledge is power and our goal for the new website is to serve as a resource for patients and their families to learn about clinical trials with information that’s scientifically sound and easily understood,” said BIO President and CEO Dr. Michelle McMurry-Heath. “All potential trial participants will benefit from the information available in one place, including traditionally underrepresented populations. Having more diverse groups in trials helps address systemic health disparities, ensuring that people are not left out of potentially lifesaving opportunities, and leading to a better understanding of how therapies and/or vaccines will work in more populations.”
Meanwhile, BIO Ventures for Global Health (BVGH), a nonprofit founded by BIO to advance global health in developing nations, has been deeply involved in efforts to expand the clinical trials landscape in Africa.
“Unfortunately, people of African descent are significantly underrepresented in clinical trials, meaning that products and regimens approved based on data from people of other ethnicities may be suboptimal for them,” Jennifer Dent, President & CEO of BVGH, explained to Bio.News. “The African Consortium for Cancer Clinical Trials (AC³T) is addressing these unacceptable disparities in the field of oncology by nurturing the growth and expansion of Africa’s cancer clinical research ecosystem.”
“In Nigeria, it’s absolutely critical that clinical trials are conducted in our population and communities,” said Professor Moji Adeyeye, Director General of the National Agency for Food and Drug Administration and Control in Nigeria (NAFDAC). “This is particularly important for cancer. Nigerians, and other African ethnicities, have unique genetics and environmental factors that must be evaluated in a clinical trial. At NAFDAC, we are collaborating with BVGH, the Bill & Melinda Gates Foundation, and others to strengthen our regulatory capacities and processes to effectively and efficiently manage and enable more international clinical studies to benefit Nigerians.”
Through efforts like these, it is possible to make progress on clinical trial diversity, thereby improving equity and the science behind these trials.
