Reporting and representation of race and ethnicity data in phase III clinical trials for hematological malignancies.

BACKGROUND

The recruitment of underrepresented racial and ethnic groups in clinical trials remains a challenge.

METHODS

The ClinicalTrials.gov database was queried for phase III trials related to non-Hodgkin lymphoma (NHL), leukemia, and multiple myeloma (MM). A reference population was sourced from the Surveillance, Epidemiology, and End Results (SEER) database.

RESULTS

A total of 53,821 pooled participants from 119 phase III trials were included in the analyses. Race and ethnicity data were reported in 95.8% and 81.5% of trials, respectively. Globally, the majority of participants were predominantly White (77.3%), followed by Asian (8.2%), Black/African American (5.4%), American Indian/Alaska Native (0.4%), and Native Hawaiian/Other Pacific Islander (0.2%), while Hispanic/Latino individuals constituted 11.0% of trial participants. In comparison to data in SEER, the proportions were lower for Asian/Pacific Islander and Hispanic/Latino across all cancers, and for Black/African American and American Indian/Alaska Native in leukemia and MM in US only trials.

CONCLUSIONS

Despite progress, reporting and representation of non-White population remain insufficient in trials. Innovative strategies to enhance representation in trial enrollment are warranted, as well as the utilization of real-world data to establish recruitment goals by more effectively assessing the demographic and geographic distribution of target patient populations.