OBJECTIVES: Racial disparities are marked in multiple myeloma (MM), where incidence is higher among Black and Hispanic individuals than White persons. Adequate representation of minority groups in oncology trials is critical to improve data and ameliorate outcomes; however, little is known about the progress toward this goal in MM. We explored regulatory and health technology assessment (HTA) agency guidance and patterns of reporting and representation in trials to understand the state of inclusion in clinical development in MM.

METHODS: We searched FDA, EMA, and prominent HTA bodies to identify guidance regarding racial diversity in clinical evidence and conducted a systematic literature review of randomized controlled trials (RCTs) in relapsed/refractory MM published between 2010 to 2020. We analyzed racial categories reported by each study and the representation of each category as a proportion of the patient population.

RESULTS: The FDA provides guidelines for the inclusion of clinically relevant racial and ethnic populations and EMA highlights inclusion of neglected populations in its 2025 strategy. ICER and IQWiG promote subgroup analyses for diverse patient groups who might experience differential treatment outcomes. NICE encourages submissions that include information on equity or equality. Of the 64 RCTs identified, 28 publications (44%) reported the racial demographic data of study participants. Most (n=26) reported a range of racial categories, while two solely presented percentage of White participants. The mean proportion of study participants by race was highest for White participants (0.721) and lower for other groups, including Black (0.070) and Hispanic (0.001) participants. When considering the proportion of participants by race and study-year, there were no clear temporal trends.

CONCLUSIONS: Despite guidance by regulatory and HTA bodies, representation did not demonstrate improvements over time. Reporting of race/ethnicity among identified trials was heterogeneous and incomplete, and the most vulnerable groups were poorly represented.