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Paper short abstract

Clinical research seeks to include underserved and underrepresented populations, yet these terms lack standardized definitions. Drawing on the READI project, this paper examines how definitions shape inclusion and patient engagement, revealing tensions between fixed categories and changing contexts.

Paper long abstract

Efforts to broaden participation in clinical research increasingly emphasize the inclusion and engagement of underserved (US) and underrepresented (UR) populations. Patient engagement is often promoted as a strategy to improve inclusion in research processes, from study design to recruitment and implementation. However, such efforts depend on how US and UR populations are defined and identified, as well as broader understandings of inclusion. Despite their widespread use in policy documents, clinical trial design, and patient engagement initiatives, these terms lack standardized definitions.

This paper examines how US and UR populations are defined within clinical research and how these definitions shape inclusion and patient engagement efforts. Drawing on findings from the European research project READI, including a literature review and qualitative interviews with stakeholders involved in clinical studies across Europe, the analysis reviews how these terms are defined across clinical research literature and trial contexts, revealing variation in how populations are identified and operationalized.

These definitional differences create misalignment in how populations excluded from clinical research are identified and included. Because engagement initiatives frequently target groups labeled US or UR, variations in definitions influence which communities are approached and how engagement strategies are designed. While defining populations enables recruitment and engagement, it also fixes particular understandings of who counts as underserved or underrepresented, potentially leaving other populations outside the frame.

The paper contributes to STS debates on participation and classification by highlighting tensions between defining populations for inclusive engagement and the context-sensitive nature of who becomes US or UR in clinical research.