Achieving clinical-trial diversity requires trust, awareness, access

By Neil Lesser, principal, Deloitte Consulting, LLP

Not everyone responds the same way to medicines and vaccines. A patient’s race, ethnicity, age, and gender could all influence how well a drug performs. While clinical trials are essential in the development of safe and effective medicines and vaccines, trial participants often don’t reflect the patient population that is likely to use a newly approved drug. As we noted in our November 2021 report, data generated by clinical trials can increase the understanding of certain diseases, which can improve prevention and treatment for all populations, including racially and ethnically diverse communities.

Nearly 80% of patients who participate in clinical trials are white, according to a multi-year study conducted by the US Food & Drug Administration (FDA).¹ Moreover, less than 20% of approved drugs have data that evaluated the treatment benefits or side-effects on Black patients, according to a recent report from Health Affairs.²

Regulators, pharmaceutical companies, patient-advocacy groups, and industry trade organizations have long recognized the importance of diversity in clinical trials. On April 13, the FDA issued new draft guidance for enrolling more participants from underrepresented racial and ethnic populations in clinical trials. This expands on the FDA’s previous guidance for improving diversity. In late 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA) published industry-wide principles on clinical-trial diversity.³  

Pharma companies target trust, awareness, and access 

Last month, I led a panel discussion on enhancing clinical-trial diversity. My panelists, who represented three large pharmaceutical companies, agreed that three barriers—trust, awareness, and access—limit the level of diversity in clinical trials. Here’s how they are working to remove those barriers.  

• Trust: Experiences with structural racism—including the Tuskegee Syphilis Study, which ended in 1972—continue to drive significant distrust of the government, pharmaceutical companies, and the health care sector in general. This distrust is sometimes further magnified by personal experiences, rumors, or traditions. Jorge Hechavarria, Ph.D., senior director of diversity, equity & inclusion in clinical trials at Janssen (the pharmaceutical companies of Johnson & Johnson), said pharmaceutical companies can build trust by continuing to engage with patients even after the trial concludes. He suggested that pharmaceutical companies could tap former clinical-trial participants to serve as ambassadors by describing their experiences with the trial. In 1996, a good prognosis for a myeloma patient was five to six years, he explained. Today, some patient ambassadors are cancer-free 20 or 25 years later. “This progress is largely because some patients took a chance and trusted the clinical trial.” 
• Awareness: Some people might not understand the benefits of clinical trials. They might not know how trials work, or even that they exist. More than 80% of PhRMA member companies said lack of awareness was a major barrier to recruiting underrepresented populations in clinical trials, according to our report, Enhancing clinical trial diversity. Some patients might be willing to participate in a clinical trial if they are aware of it. A lack of awareness among patients might reflect a lack of awareness amongst physicians, or biases that investigators have when seeking patients who may be eligible to participate in clinical trials, explained Judy Sewards, vice president and head of clinical-trial experience at Pfizer. “In our landmark COVID-19 vaccine trial, we took care to ensure that we selected clinical-trial sites in communities where we saw high rates of COVID-19 infections,” she explained. The company wanted to help reduce or eliminate any transportation issues that might keep people from participating. She added that that Pfizer also partnered with “trusted voices” (e.g., community, medical, and grassroots organizations) to help improve awareness. Information and listening sessions were held to answer questions about the clinical trials and to collect feedback from community partners. The feedback was then used to create educational materials that were tailored to the community, Judy explained.
• Access: All patients, regardless of background or social status, should have the opportunity to participate in clinical trials that are developing the latest breakthrough medicines, Judy said. However, a wide range of factors can make it difficult for some people to participate in clinical research. Some people might not be able to take time away from work. The cost of childcare and travel might also hinder access. Although virtual clinical trials have helped to expand access to some participants, people who lack reliable internet connectivity might be unable to participate virtually. A data-driven approach to identifying clinical trial sites might help improve access, suggested LaShell Robinson, director of diversity and inclusion in clinical trials at Takeda. She suggested that feasibility questionnaires (used to evaluate potential sites) could ask about staff diversity, languages spoken by staff, or demographics of the patient population. “We are embedding and factoring for diversity as a component in site selection,” she said.

Pharma companies might need to be myth busters

The COVID-19 pandemic shined a light on health disparities. In the US, the virus had a disproportionate impact in Black and Latino communities. LaShell said the pandemic created an opportunity to dispel some of the myths about clinical trials and explain how research and development affects medications. Takeda has begun asking its investigative sites to collect information about the race and ethnicity of participating patients and is urging them to make sure that the trials are accessible. “Unconscious biases can seep into that process and really impact awareness, access, and participation in communities of color,” she explained.

Jorge agreed that many pharmaceutical companies are battling conflicting messages and misinformation, particularly in communities of color. He also suggested that using investigators who look like members of a community could help put patients more at ease. 

Pharmaceutical companies are using a wide range of tactics to attract a more diverse patient population. Some are forging partnerships with community organizations to build trust, spread awareness, and improve access. Others are providing participants with financial support, and a few are looking to move some trials to convenient locations, such as retail clinics, as my colleague Dawn Anderson described in a recent blog. 

Even the best intentions won’t move the needle on clinical-trial diversity unless the strategies are implemented, Jorge said. Commitment from the top is critically important. Most large biopharma companies have identified equitable access and equity in research as a material issue in their environmental, social, and corporate governance disclosures, and many have assigned improvement as a priority for senior management.  

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¹ 2015-2019: Drug Trials Snapshots, US FDA, November 2020

² Despite the FDA’s five-year plan, Black patients remain inadequately represented in clinical trials for drugs, Health Affairs, March 2022

³ PhRMA announces first-ever, industry-wide principles on clinical-trial diversity, PhRMA press release, November 17, 2020

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