Design of a card-based operational framework for the implementation of inclusive representation in clinical trials

This framework has been designed to support companies and sponsors, specifically referring to pharmaceutical companies interested in strengthening the representation of real-world patients in clinical trials. The CBOF translates diverse representation, health equity, and inclusion principles into structured, actionable guidance for clinical trial sponsors. It addresses longstanding operational gaps by combining decision-support tools, role-specific delegation, and measurable KPIs across development phases and trial stages. While further validation in real-world settings is needed, the framework represents a practical advancement in operationalizing inclusive trial design and supporting sponsors in meeting regulatory and ethical expectations.