(HealthDay News) — Eligibility criteria may contribute to racial and ethnic disparities in enrollment in multiple myeloma (MM) clinical trials, according to a study published in Blood.
Researchers examined the rates and reasons for trial ineligibility by race and ethnicity in MM trials. They conducted a pooled analysis of 16 trials submitted to the US Food and Drug Administration between 2006 and 2019 to support the approval of MM therapies.
Of the 9325 patients screened for these trials, 17% were deemed ineligible. Ineligibility rates were 24% among Black patients, 20% in patients of unknown race, 17% in White patients, 12% in Asian patients, 23% in patients of other races, 20% in Hispanic patients, 16% in non-Hispanic patients, and 19% in patients of unknown ethnicity.
The most common reason for ineligibility in the overall population was failure to meet disease-related criteria (25%). This was the most common reason for ineligibility in White patients (28%), Asian patients (29%), Hispanic patients (21%), and non-Hispanic patients (27%) as well. The most common reason for ineligibility among Black patients was failure to meet protocol-specific hematologic lab criteria (19%).
“Our analysis indicates that specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups in MM clinical trials,” the researchers wrote. “However, the small number of screened patients in underrepresented racial and ethnic subgroups limits definitive conclusions.”
One researcher disclosed financial ties to COTA Healthcare.
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