Reporting and enrollment disparities in hematologic malignancy trials between 2000-2023

Area of Science:

• Oncology
• Clinical Trials
• Health Disparities

Background:

• Despite efforts to improve diversity, clinical trials for hematologic malignancies (HM) continue to show persistent disparities.
• Enrollment of underrepresented racial and ethnic groups in HM clinical trials lags behind general population benchmarks.

Purpose of the Study:

• To assess trends in demographic reporting (race and ethnicity) and participant representation in US-based phase II-III HM clinical trials from 2000 to 2023.
• To compare enrollment data with Surveillance, Epidemiology, and End Results (SEER) benchmarks to identify specific disparities.

Main Methods:

• A comprehensive review of 1,230 US-based phase II-III HM clinical trials involving 149,434 participants.
• Analysis of demographic reporting rates and participant demographics, comparing trials initiated before and after 2016, and by sponsor type (NIH, institutional, industry).

Main Results:

• Race was reported in 59% of trials and ethnicity in 40%, with significant improvements in reporting for trials initiated after 2016.
• Black and Hispanic individuals were consistently underrepresented, particularly in multiple myeloma and acute lymphoblastic leukemia trials.
• NIH-sponsored trials showed higher odds of reporting demographics and enrolled more Black participants compared to institutional and industry trials.

Conclusions:

• Significant disparities in race and ethnicity reporting and participant representation persist in hematologic malignancy clinical trials.
• Enforceable mandates for demographic reporting and representation targets are crucial to ensure equitable access and generalizability of trial findings.