Information from clinical development analytics solutions firm Phesi, culled from protocol design data from more than 1.3m US patients from Phase II and III trials across 1,580 cohorts, indicates that the clinical research industry is seeing greater increases in representation among Black patients than other groups. According to the company, results showed that Asian, Hispanic/Latino, Native Americans and Alaska natives, Native Hawaiians, and other Pacific Islander patient subpopulations all were markedly, consistently underrepresented over the course of the decade.
Gen Li, president of Phesi, said the industry continues to increase its understanding of how different treatments might impact different demographics, and research into genetic biomarkers is continuing.
“Trial sponsors are making a concerted effort to address the lack of ethnic group representation, and there is also growing pressure from the public as understanding of clinical trials is increasing following the COVID-19 pandemic,” Li commented. “More than 70% of the population believe patients need more access to clinical trials and opportunities to participate. The demand is clearly there for wider inclusion, and to meet it, sponsors must become more data-driven to ensure that new treatments are efficacious for all ethnic and racial groups, whenever applicable.”
What’s more, Li said, it is vital that diversity and inclusion are considered in combination with other factors, not in isolation.
“We know that a patient’s race can affect how they respond to drugs; pharmacogenetic differences in Asians may affect their responses to important drugs such as Warfarin and Clopidogrel, increasing and decreasing drug response respectively,” Li pointed out. “The FDA has also approved Bidil [isosorbide dinitrate/hydralazine], the only heart failure medicine approved specifically for African Americans, but we’ve also seen over the last two years of the pandemic how other factors not related to race can affect outcomes.”
“Our own research has shown that obesity is a major complicating factor and the biggest predictor of COVID-19 symptom severity,” Li continued. “The key takeaway is that sponsors optimizing the design of their clinical trials in any disease must be better informed by leveraging the variety and volume of real-world and real-time data available to them today.”
In Figure 1, data indicates that Black and African American patients apparently have become better represented over the course of the past decade, making up 14.9% of the data set, compared to 13.4% of the total US population in the 2019 US Census Bureau estimates. According to Phesi, this increase can be attributed to concentrated efforts by the research industry to improve racial diversification, and to patient advocacy groups for diseases disproportionally impacting Black/African Americans in the US.
Phesi points out the data constitutes a wide view of trials over the last decade and should not be taken to mean work to ensure adequate representation of Black/African American participants in clinical trials is done. Additionally, other racial groups are still markedly underrepresented in trials.
“Patient subgroups in clinical trials continue to evolve as availability of real-world data allows sponsors to design more precise and targeted trials; the demand for inclusion also extends into other characteristics like sex and age,” commented Paul Chew, Phesi’s chief medical officer. “To further advance our understanding of diversity, we will need to see greater alignment between sponsors and government and regulatory bodies, to ensure clinically meaningful classifications are standardized.”
Chew added that sites and sponsors should work to address barriers and concerns of patients from specific groups that arise from their historical treatment in research, ensuring all are fairly represented in the clinical development process.
“The good news for sponsors is that technology and integrated data sets are available today that are driving the development of synthetic patient profiles,” Chew continued. “This predictive analytics approach helps to address inclusion issues and to accelerate trials. In addition, the advances that we’ve seen in virtualized and decentralized trial throughout COVID-19 has shown that geography should be a factor in trial participation. We should see the results of these new technology and data-driven approaches trickle through into increased diversity in trial data.”