Gender Disparity in Enrollment in Clinical Trials for Hairy Cell Leukemia Treatments in the Last 40 Years

Abstract

Background

Hairy Cell Leukemia (HCL) is a B-cell lymphoproliferative disorder that predominantly affects males, yet recent evidence suggests a notable gender participation gap in HCL clinical trials. This study aims to characterize that disparity and explore potential factors contributing to the under-enrollment of females.

Methods

In this descriptive, retrospective study, we searched EMBASE, PUBMED, Cochrane Central, and ClinicalTrials.gov from January 1983 to December 2023 for publications on clinical trials (CT) in HCL, descriptive statistical analysis of all the sociodemographic variables was performed.

Results

We analyzed 57 clinical trials totaling 4595 HCL patients, with 79.1% male and 20.9% female participants. The male-to-female ratio declined from 5.91 (1983–1993) to 4.19 (2014–2023). Although the gender gap narrowed over time, female participation slightly decreased to 19.2% in the most recent period (2014–2023).

Conclusions

Female enrollment in HCL clinical trials remains disproportionately low compared to incidence rates, underscoring the need to address underlying barriers to improve equity in clinical research and treatment outcomes.

Trial Registration

The authors have confirmed clinical trial registration is not needed for this submission.