Pfizer’s clinical trials diversity report showed the disproportionate way the virus impacted minority communities in the U.S., increasing the calls for racial and ethnic diversity in clinical studies.
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The COVID-19 epidemic highlighted the disproportionate way the virus impacted minority communities across the U.S., increasing the calls for racial and ethnic diversity in clinical studies. While there has been a more significant push, a recent Pfizer clinical trials diversity report shows there is still a wide gap that needs to be bridged.
Historically, minority populations have been underserved by the life sciences community, particularly in clinical studies. Some studies have shown that medications that treat a broad population of patients are less effective in minorities, such as the asthma drug albuterol.
Pfizer took a clinical trial enrollment snapshot of participants between 2011 and 2020 to establish a diversity baseline. The snapshot includes 213 trials with 103,103 participants from the United States.
The company’s data shows that participation from Black or African Americans was 14.3%. U.S. Census data showed that Black or African Americans made up 13.4% of the U.S. population.
Pfizer noted that 15.9% of its trial participants were Hispanic or Latino, compared with the census level of 18.5%. When it comes to Asians, 3.1% of participants were Asian, compared with 5.9% from the census.
Whites were overwhelmingly involved in the clinical process. According to the data, 80.4% were White compared with 76.3% from the census.
At 56.1%, more than half of Pfizer trials achieved census levels for Black or African American participants.
For Caucasian participants, the level was 51.4%, and for Hispanic or Latino participants, the numbers were at 52.3%. The percentage of trials that achieved census levels was much lower for Asians at 16.0%, as well as Native Hawaiian or Other Pacific Islander, 14.2%, and American Indian or Alaska Native participants at 8.5%.
Pfizer said a majority of the total participant data set is derived from vaccine trial participation in its report. That means that the race and ethnicity representation in those studies substantially impacted the overall race and ethnicity distribution across the complete participant data set. However, the company was quick to note that its vaccine trials had a lower percentage of Black or African American and Hispanic or Latino participants and a higher percentage of Asian, White, and Non-Hispanic White participants.
The importance of diversity of patients in clinical studies cannot be overlooked. The need for greater variance of ethnicities and races in clinical trials has been an increasing concern, now heightened by the COVID-19 pandemic.
Last year, during the frenzied height of accelerated clinical studies for vaccines and therapeutics for COVID-19, a New England Journal of Medicine report revealed that the racial and ethnic minority groups most negatively impacted by COVID-19 are also the least represented in these clinical studies. Genentech also launched a minority-specific research last year, assessing its rheumatoid arthritis drug Actemra as a potential treatment for COVID-19.
Pfizer said establishing the baseline was important to improve its own goals of racial and ethnic diversity in clinical trials.
“Such a baseline will enable continued and quantifiable assessment of how improvement efforts contribute to enhanced diversity in clinical trials. We cannot reduce inequities in trial participation unless we better understand the current situation. This paper provides an analysis of where we are today, so we can improve in the future,” the company said.
Pfizer said it is committed to “achieving racially and ethnically diverse participation at or above U.S. census or disease prevalence levels” when appropriate in all of its clinical trials.
“Sharing our baseline on clinical trial diversity is the beginning of continued transparency on our progress toward this commitment. We also plan to publish learnings from future scholarship on this topic and are encouraging other clinical trial sponsors to make similar commitments as it will take the full community to impact this important topic,” the company said.
