Black patient inclusion in clinical trials improves, but Asian, Latino and other groups 'significantly' underrepresented

The number of Black and African American patients in clinical trials has risen over the past decade, but the drug development industry "significantly and consistently" leaves Asian, Hispanic, Latino and other groups underrepresented. 

That's based on 10 years of data across phase 2 and 3 single-country clinical trials. Clinical development data provider Phesi looked at data on 1.3 million U.S. patients involved in trials that began in the past decade. That represents 495 different diseases across mid- and late-stage studies.

Nearly 15% of participants in those clinical trials over the past decade were Black patients as compared to the demographic's 13.4% makeup of the total U.S. population in 2019, Phesi said. That improvement is due to industry efforts and patient advocacy groups, the company said. 

While the picture appeared to improve for Black patients, most minority populations are still underrepresented in clinical trials, Phesi said. Asian Americans made up 2.61% of the trials examined; Hispanic and Latino patients comprised 12%, and Native Americans and Alaska Natives represented less than 1%.

Phesi's data looked at mid- and late-stage studies without specifying how many of those trials were used by biopharmas to secure drug approvals. For trials that supported FDA-approved medicines last year, the percent of Black patients included was far less: 8%, according to the agency. Hispanic patients comprised 11%, and Asian patients made up 6% of those trials. 

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Meanwhile, white patients comprised 67.6% of the trials. That's compared to the 60.3% of America that is white, Phesi said. 

"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," said Gen Li, Ph.D., president of Phesi, in a statement. 

Phesi emphasized the need for increased inclusion of underrepresented groups by beefing up data approaches, strengthening alignment between sponsors and regulatory bodies and a broad effort to address historical barriers and concerns that limit trial participation for certain groups. 

Clinical research organizations, site sponsors and drug developers have inked real-world data and real-world evidence pacts in recent quarters with collaborations bringing together data on millions of anonymized patients.

“The good news for sponsors is that technology and integrated data sets are available today that are driving the development of synthetic patient profiles. This predictive analytics approach helps to address inclusion issues and to accelerate trials," said Paul Chew, M.D., chief medical officer at Phesi, in a statement. 

Advancements in virtual and hybrid trials will "trickle through into increased diversity in trial data," Chew said.