Designed Without Women: The Behavioral Barriers Holding Medicine Back, and What To Do About Them

Author(s): Lisa Campbell & William Hind

During the past decade, regulators and researchers including the FDA, EMA, NIH, and ICH have issued guidance encouraging gender‑inclusive research. Yet in practice, development decisions continue to default to male‑centric designs and post hoc subgroup analyses. The guidance exists. So why does behavior not change?

As the first two articles in this series explored, the issue is not a lack of awareness or policy. It is that behavior is shaped by how regulators’ expectations are interpreted, prioritized, and reinforced within real-life organizational settings.

This article reframes the female data deficit as a behavioral problem. If the healthcare industry wants consistent inclusion to move from lofty aspiration to routine practice, we need to understand the specific behavioral barriers at play and design interventions that work with—rather than against—how teams actually make decisions under pressure.