Presentation (CTI)

OBJECTIVES: Despite increased recognition of the need for inclusive and representative clinical research, many populations (e.g., older adults, historically excluded ethnic groups) across Europe remain underrepresented, limiting generalisability of evidence and contributing to inequity in healthcare decisions. Regulatory and health technology assessment (HTA) bodies play a central role in shaping evidence standards and expectations. As part of READI, this review assessed the regulatory and HTA landscape relating to clinical study representativeness and inclusivity, identifying key gaps and challenges in policy frameworks and methodological approaches.
METHODS: A grey literature review of policies, guidelines, position statements and recommendations was conducted across 26 European and 12 international regulatory and HTA bodies, to ensure geographical and organisational representation. Targeted website searches (November 2025 to February 2026) identified documents, which were screened by two reviewers against predefined inclusion criteria, extracted and synthesised narratively.
RESULTS: 266 documents were included. Findings indicate that consideration of representativeness and inclusivity in clinical studies was variable and inconsistently defined. While some bodies acknowledged the importance of inclusive research, relatively few provided detailed or operational guidance on how this should be achieved. Two regulatory bodies provided guidance on diversity action plans (Medicines and Healthcare products Regulatory Agency/Health Research Authority; Food and Drug Administration); while others emphasised that study enrolment should reflect the intended treatment population across demographic and clinical characteristics. HTA bodies addressed inclusivity indirectly through population representativeness, generalisability and subgroup analyses, without specifying priority populations. Only the Institute for Clinical and Economic review (US) developed a tool assessing clinical trial diversity (age, sex and race/ethnicity).
CONCLUSIONS: Findings highlight a non-prescriptive landscape, with limited alignment on definitions and expectations, and few actionable tools or methods to assess and operationalise clinical trial representativeness and inclusivity. The READI project aims to build on these findings to develop multistakeholder policy recommendations to support more consistent approaches in Europe.