Research

We Must Mitigate Bias When Planning for PAD/CLTI Trials

04/04/2025

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How can we design peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) trials that actually reflect the patients we treat every day? In his CRT 2025 presentation, Dr. Zola M. N'Dandu addressed the urgent need to mitigate gender and minority bias in the planning and administration of clinical trials for PAD / CLTI.

PAD disproportionately affects women and underrepresented minorities, yet these same groups remain consistently under-enrolled in clinical research. The result is trial findings that don’t always translate to real-world populations, and treatments that may fall short where they are most needed. Equitable representation, Dr. N'Dandu notes, is essential for generating evidence that leads to better, more personalized care.

Trials can be proactively designed with inclusive enrollment strategies, from site selection and community engagement to protocol development and data analysis. Dr. N'Dandu notes LIFE-BTK and ELEGANCE are two recent trials that have shown success in addressing these concerns.

If we want trial results that truly inform our decisions for care, we must reimagine how we recruit, enroll, and represent our patients. Hear more from Dr. N'Dandu below: