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Have Federal Regulations Improved Racial and Ethnic Disparities in Acute Leukemia Clinical Trials?

By: Gavin Calabretta, BS
Posted: Tuesday, October 12, 2021

Recent findings from a study published in Blood Advances suggest that federal regulations established to mitigate racial and ethnic disparities in clinical trial enrollment did not involve Black and Hispanic patients in acute leukemia research. The study authors' findings illustrate that demographic enrollment reporting for acute leukemia trials remains inadequate, and enrollment diversification strategies are needed.

“Underrepresentation in clinical trials can bias how we develop drugs and administer care, which can then perpetuate treatment disparities for members of historically disadvantaged groups,” commented study author Andrew Hantel, MD, of Dana-Farber Cancer Institute, Boston, in a press release from the American Society of Hematology. “There are a lot of ideas about different actions the hematologic oncology community can take to improve enrollment of diverse populations in clinical trials, so we aimed to generate specific data to spur a change for this issue.”

The study analyzed demographic data from 260 United States–based acute lymphocytic (ALL) and acute myeloid leukemia (AML) trials from 2002 to 2017. The data were compared with annual disease incidence rates in the Surveillance, Epidemiology, and End Results cancer database to deduce enrollment rates of five racial/ethnic categories: non-Hispanic (NH) White, NH Black, NH Asian, NH Native American/Alaska Native, and Hispanic.

Among trials that reported race and ethnicity, NH-Black, NH-Asian, NH-Native American, and Hispanic individuals had significantly lower enrollment compared with NH-White individuals, even after accounting for race/ethnic disease incidence (AML odds = 0.68, 0.31, 0.75, and 0.83; ALL = 0.74, 0.27, 0.67, and 0.64; all P ≤ .01). Additionally, after reporting requirements were enacted, the percentages of trials reporting race and trials reporting proportions by the number of patients enrolled increased; however, race/ethnicity reporting did not, and relative enrollment of NH-Black and Hispanic patients decreased (AML odds = 0.79 and 0.77; ALL odds = 0.35 and 0.25; both P ≤ .01).

Disclosure: For full disclosures of the study authors, visit ashpublications.org.



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