Achieving clinical-trial diversity requires trust, awareness, access | Deloitte US has been saved
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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 On April 13, the FDA issued new draft guidance for enrolling more participants from underrepresented racial and ethnic populations in clinical trials.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.
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
Neil is a principal with Deloitte Consulting LLP in the Life Sciences strategy practice and a leader in the Research & Development strategy practice. He joined Deloitte in 1998 and works with life sciences executives creating and implementing strategies that drive productivity, efficiency, and value. He leads strategy, operating model design, productivity improvement, and large transformation initiatives within R&D and Regulatory Affairs. Neil is a frequent writer and speaker on R&D productivity.