Racial and Ethnic Diversity in Acute Leukemia Clinical Trials Does Not Appear to Improve With Disparity and Demographic Reporting Requirements

After implementing disparity and demographic reporting in acute leukemia clinical trials, investigators did not report an increase in diverse trial participants.

Measures meant to tackle racial and ethnic disparities for acute leukemia clinical trials did not appear to increase enrollment of Black and Hispanic patients, according to the results of a study published in Blood Advances.1

Data from the study indicated that after adjusting for race-ethnic disease incidence among trials that reported such factors, non-Hispanic Black, Native American, Asian, and Hispanic patients experienced lower enrollment vs non-Hispanic White patients in both acute myeloid leukemia (AML; odds ratio [OR], 0.68, 0.31, 0.75, and 0.83, respectively) and acute lymphocytic leukemia (ALL; OR, 0.74, 0.27, 0.67, and 0.64; P ≤.01). Although the proportion of trials reporting racial data increased from 44.2% to 60.2% (P = .02) following reporting requirements, diversity did not appear to improve (34.8% vs 39.6%, respectively; P = .57).

“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,” study author Andrew Hantel, MD, a medical oncologist at Dana-Farber Cancer Institute, said in a press release.2 “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.”

Investigators behind the study examined demographic data reporting and enrollment diversity in both ALL and AML clinical trials that took place from 2002 to 2017. Additionally, changes in reporting and diversity following implementation of reporting requirements were assessed. A total of 223 AML and 97 ALL clinical trials were included in the assessment, 30.5% of which reported enrollment by race and 52.6% by ethnicity. Moreover, 6554 AML trials and 4148 ALL trials reported both race and ethnicity.

Additional findings from the trial indicated that reporting proportions by the number of patients who enrolled appeared to significantly increase in terms of race (51.7% to 72.7%) and race-ethnicity (39.5% to 45.4%; P <.001) following reporting requirements, although the relative enrollment of Black and Hispanic patients appeared to decrease (AML OR, 0.79 and 0.77; ALL OR, 0.35 and 0.25; P ≤.01).

Investigators concluded that these findings indicate that demographic enrollment reporting within this patient population appears to be suboptimal and that changes in diversity following implementation reporting requirements may be attributed to other unreported enrollment disparities.

“It is essential that we capitalize on the new and exciting treatments in the last ten years that have changed leukemia prognosis. These data are a first step toward equitably providing these better, newer treatments to all,” Hantel concluded.

References

  1. Hantel A, Luskin MR, Garcia JS, et al. Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials. Blood Adv. Published September 2, 2021. doi:10.1182/bloodadvances.2021005148
  2. Demographic reporting requirements did not improve enrollment of Black and Hispanic patients in acute leukemia clinical trials. News release. American Society of Hematology. September 2, 2021. Accessed September 7, 2021. https://bit.ly/2VrLA2A