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Underrepresentation in clinical trials is not only an ethical concern, it is also a reproducibility and safety concern that propagates bias into evidence-based care and downstream clinical artificial intelligence (AI). We propose ‘Inclusion by Design’: a policy and governance approach that makes representation measurable, auditable and correctable within existing trial and data infrastructures. The EQUITRIAL framework we have developed operationalizes this approach with a ten-domain model of exclusion, across individual, contextual and cultural dimensions. EQUITRIAL adopts two lightweight indicators (representation ratio and intersectionality score) to embed inclusion as a measurable parameter, not an ethical aspiration. It also includes a practical inclusion plan template to translate EQUITRIAL into policy actions aligned with global regulations. This is key as regulators enter a unique policy window for action.
