Barriers and solutions to ethnic diversity in breast cancer clinical trials: a systematic review.

[OBJECTIVES] Ethnic minorities remain significantly underrepresented in breast cancer clinical trials, limiting the generalizability of findings and perpetuating disparities in outcomes. This systematic review aims to identify major barriers to participation and evaluate the effectiveness of strategies proposed to enhance inclusion.

[DESIGN] We conducted a systematic review of studies published in the last ten years using PubMed, focusing on ethnic representation in breast cancer trials. Studies were selected using the SPIDER tool and assessed for quality with appropriate instruments according to study design, including CASP, ISPOR, CONSORT, and CARE.

[RESULTS] Fifteen studies met the inclusion criteria. The most frequently reported barriers were language and health literacy limitations, mistrust of the healthcare and research systems, financial and logistical constraints, and insufficient provider involvement in recruitment. Strategies to address these issues included culturally adapted educational interventions, deployment of patient navigators with cultural and linguistic concordance, provision of financial assistance and transport, decentralized trial access, and training for healthcare professionals to enhance cultural competence and inclusive communication.

[CONCLUSION] Addressing disparities in clinical trial participation among ethnically diverse populations requires a multilevel approach. Interventions must combine cultural competence, community engagement, and structural changes within research systems. Improving inclusion is not only a matter of health equity but also crucial for the scientific validity and applicability of precision oncology across diverse populations.