CARE Framework for Inclusive Clinical Studies: An Evidence-Based Approach for and Measurement of Recruitment and Retention of Black Women in Breast Cancer Research.

This publication outlines a practical framework to improve inclusion of under-represented women—specifically Black women with breast cancer—in clinical research.

Core points:

• Problem defined: Despite advances in breast cancer treatment and outcomes, women who are disproportionately affected—particularly Black women—remain under-represented in clinical studies, limiting the generalizability and equity of research findings.

• Framework focus:
  • Identifies structural and systemic barriers that impede participation of Black women in trials.
  • Emphasizes the need to intentionally design studies that address these barriers rather than treating under-representation as an incidental issue.

• Key determinants of recruitment and retention:
  • Incorporates patient perspectives on trust, communication, cultural relevance, logistical barriers (e.g., time, transportation), and perceived value of participation.
  • Stresses bidirectional engagement with communities and tailoring outreach and consent processes to patient needs.

• Broader applicability:
  • Positions the framework as a model that can be adapted to other therapeutic areas to:
    • Improve representativeness of study populations,
    • Enhance patient engagement, and
    • Inform more equitable and inclusive study design and conduct.

The piece is essentially a guidance-oriented report aimed at operationalizing equity in clinical research participation, with a focus on Black women with breast cancer.