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# Pediatric Cancer Trial Subjects Appear Representative: Study
- URL: https://www.fdaweb.com/pediatric-cancer-trial-subjects-appear-representative-study/
- Published: 2024-01-04T12:00:00.000Z
- Updated: 2026-09-14T14:19:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156082

A retrospective study conducted by researchers from the FDA Oncology Center of Excellence and the National Institutes of Health found that overall, the representation of participants of racial and ethnic minority groups in studies supporting pediatric exclusivity requests appears to be comparable to the racial distribution of childhood cancers in the U.S. However, the [report](https://pubmed.ncbi.nlm.nih.gov/38175622/?ref=fdaweb.com) says, fewer Hispanic participants were enrolled in the trials that were reviewed (8%), compared with the representation of Hispanic patients in the National Childhood Cancer Registry (28%).

“This discrepancy may be partially explained by the large proportion of participants with unknown information regarding ethnicity,” the report suggests. “Further research into the reasons for the large proportion of participants with missing ethnicity information is needed.”

The study examined pediatric exclusivity request submissions for oncologic drugs that received pediatric exclusivity between 12/2001 and 1/2021, based on fulfillment of the requirements of a written request under the Best Pharmaceuticals for Children Act.

The researchers looked at 22 pediatric exclusivity requests, comprising 40 studies and 2,025 patients. The racial and ethnic representation was American Indian/Alaska Native, 0.6%; African American/Black, 11.3%; Asian, 4.6%; Native Hawaiian/other Pacific Islander, 1.6%; White, 64.3%; other, 9.6%; and unknown/not reported 8%. Representation by sex the report says, was female individuals, 41.2%, and male individuals, 58.8%. Ethnicity was shown as Hispanic, 5.7%; non-Hispanic, 22.5%; unknown/not reported ethnicity, 69.1%; and other ethnicity, 2.8%.