Abstract

This article provides an overview of patient representation in clinical trials and considers how this can be enhanced, with an emphasis on the importance of including all clinically relevant populations to ensure the generalisability and applicability of research findings.

Regulatory agencies, such as the European Medicines Agency (EMA) and Health Canada, have issued guidance and frameworks to improve enrolment practices and promote robust data collection and analysis. Being proactive with community outreach and compliant with regulatory guidelines can both facilitate public trust and support sponsors to meet regulatory milestones.

Above all, this article underscores the global regulatory commitment to promoting representation in clinical trials, which enhances the reliability and applicability of clinical research outcomes across all populations.