Racial and Ethnic Disparities Among Patients Enrolled in Breast Reconstruction-Related Clinical Trials

Area of Science:

• Medical research
• Clinical trials
• Health equity

Background:

• Breast reconstruction clinical trials (BRRCTs) are crucial for improving patient outcomes.
• Ensuring BRRCTs reflect the racial and ethnic diversity of breast cancer patients is essential for accessibility and equitable outcomes.

Purpose of the Study:

• To evaluate the reporting of race and ethnicity in US-based BRRCTs.
• To compare the reported race and ethnicity of clinical trial enrollees with breast cancer incidence rates in the general US population.

Main Methods:

• Retrospective review of US-based BRRCTs completed and available on ClinicalTrials.gov.
• Data collected included patient age, race, ethnicity, and trial funding.
• Enrollment rates of racial and ethnic groups were compared to expected representation based on breast cancer incidence.

Main Results:

• Only 28% of 25 reviewed BRRCTs reported enrollees' race, and 20% reported both race and ethnicity.
• White patients constituted 90.8% of enrollees, significantly overrepresenting their breast cancer burden (26.4%).
• Minority groups, including Black (3.5% vs 24.9%), Asian (1.5% vs 23.9%), and Hispanic/Latino (7.6% vs 45.2%), were significantly underrepresented.

Conclusions:

• Over 70% of BRRCTs failed to report essential demographic data on race and ethnicity.
• Significant underrepresentation of racial and ethnic minorities in BRRCTs was observed.
• Improved reporting and targeted recruitment strategies are necessary to enhance the validity and inclusivity of breast reconstruction research.