Preserving and Promoting Clinical Trial Representativeness: A Review of Existing Strategies and the Path Forward.

Abstract

Importance Despite major advancements in cardiovascular clinical research, underrepresentation in cardiovascular clinical trials persists, limiting generalizability, access to novel therapies, and equitable care. Observations Policymakers, funding bodies, researchers, and professional societies have increasingly acknowledged the scientific importance of representation of the intended use population in cardiovascular clinical trials through policies and incentives, yet significant challenges remain. Achieving meaningful representation requires more than meeting enrollment targets, it demands the integration of best practices into trial design, including tailored recruitment strategies, diverse leadership, standardized demographic data collection, and clear accountability metrics. Conclusions and Relevance This review synthesizes the latest policies and initiatives concerning representation in clinical research and provides a strategic framework to ensure scientific validity of clinical trials by operationalizing broad representation at all levels. A coordinated approach among stakeholders is needed to address the scientific value of trial representation of the intended use population.