Do we still need broad patient representation in breast cancer trials? Absolutely.

A critical question in a shifting global landscape

Expanding patient inclusion in breast cancer clinical trials is not only an ethical obligation but also a scientific and business necessity for producing reliable, applicable data that supports global approval, reimbursement, and market access. While regulatory guidance documents on diversity continue to develop, they differ by region, causing short-term uncertainty for sponsors.

Nevertheless, even without regulatory mandates, broad patient inclusion—beyond race and ethnicity—is crucial for long-term scientific integrity, a smooth regulatory process, and lasting commercial success. 

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