Patient race and ethnicity are underreported in early phase pediatric cancer trials, according to research published in The Oncologist.

Race and ethnicity were reported in less than 25% of the trials studied. The trials that did include race/ethnicity data showed proportions of Black and Hispanic patients that were similar to the proportion of Black and Hispanic individuals in the general US population. 

Researchers conducted this study to determine if racial/ethnic minorities are underrepresented in pediatric cancer trials and to evaluate the outcomes of these patients.

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The researchers analyzed data from a previously published systematic review of phase 1 pediatric cancer trials published between 2012 and 2018.

Of the 109 articles published, 33% reported race or ethnicity as part of the baseline patient characteristics. Both race and ethnicity were provided in 21% of the articles. In these studies, 23.7% of patients were Hispanic, and 16.6% of patients were Black.

“Although we are encouraged that representation in the small subset of trials (21%) that reported complete demographic information by race and ethnicity was comparable to the current US demographic landscape, without additional data, we simply cannot assume this is an accurate reflection of the landscape of enrollment across early phase pediatric oncology studies,” the researchers wrote. 

They also found no consistent pattern for reporting race or ethnicity data over time. The lowest percentage of trials reporting such data was 18% in 2016, and the highest percentage was 42% in 2014. 

Only 1 study reported treatment outcomes by race and ethnicity.

“Our study serves to highlight the critical need to improve reporting of racial/ethnic representation in early phase pediatric oncology trials,” the researchers wrote. “Given how readily available such demographic information is, this should be a standard approach when reporting on trial data, even when numbers are limited.”

Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Faruqi AJ, Ligon JA, Cohen JW, et al. Reporting of racial and ethnic minority representation in early phase pediatric oncology clinical trials. Oncologist. Published online July 6, 2022. doi:1093/oncolo/oyac124