More work needed to diversify clinical trials, data show

Apart from white patients, other racial groups in US clinical trials are being significantly and consistently under represented, according to new research.  

The data come from clinical data company Phesi, which analysed protocol design data from 1,324,820 US patients, from Phase 2 and 3 single country clinical trials across a total of 1,580 cohorts. The data set represented 495 disease conditions throughout 2010–2020.

Results of the data show that Asian, Hispanic and Latino, Native Americans and Alaska natives, Native Hawaiians and other Pacific Islander patient subpopulations were all significantly and consistently underrepresented over the decade.

More so, across the decade, Black and African American patients made up 14.92% of patients within these clinical trials – an increased compared to the 13.4.% estimated in the 2019 US Census Bureau.

Phesi argues that this slight increase could be due to industry efforts to improve racial diversification, as well as work by patient advocacy groups for diseases disproportionally impacting Black/African Americans in the US.

“The number of patient subgroups is increasing as we expand our understanding of how therapies affect certain demographics and continue to research genetic biomarkers,” commented Dr Gen Li, president, Phesi. “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. 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.”

“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,” added Dr Paul Chew, chief medical officer at Phesi. “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 standardised. Moreover, the industry must address the barriers and justified concerns of patients due to historical treatment in trials to ensure everyone is included and fairly represented in the clinical development process.”

One of the answers to better diversification in clinical trials could be the use of technology, particularly the use of synthetic patient profiles, Dr Chew argues.

“This predictive analytics approach helps to address inclusion issues and to accelerate trials. In addition, the advances that we’ve seen in virtualised and decentralised 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,” Dr Chew said.

Dr Li added: “It’s also important that when considering diversity and inclusion that we don’t look at issues 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. 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. The key takeaway is that sponsors optimising 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.”