Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory

Abstract

Importance: Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups.

Observations: Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at improving trial representation, gaps in trial enrollment proportionate to the racial and ethnic composition of the HF population have persisted. Increasing trial globalization with limited US enrollment is a major driver of these patterns. Additional barriers to representative enrollment include inequities in care access, logistical issues in participation, restrictive enrollment criteria, and English language requirements.

Conclusions and relevance: Strategies for improving diverse trial enrollment include methodical study design and site selection, diversification of research leadership and staff, broadening of eligibility criteria, community and patient engagement, and broad stakeholder commitment. In contemporary HF trials, diverse trial enrollment is not only feasible but can be efficiently achieved to improve the generalizability and translation of trial knowledge to clinical practice.

Figure 1.

Enrollment of Racial and Ethnic Minority Groups in Select Heart Failure (HF) Medical Therapy Trials Proportion of racial and ethnic minority groups in select clinical trials is displayed as a percentage of total participants. When reported, the proportion of Black participants is shown. This analysis was not intended to be a systematic review of all trials meeting specific criteria, but rather a sampling of pivotal trials, many of which supported regulatory approval of the studied therapy. ^a Further breakdown of racial and ethnic groups was not provided in clinical trial publications.

Figure 2.

Enrollment of Racial and Ethnic Minority Groups in Key Heart Failure (HF) Device Trials Proportion of racial and ethnic minority groups in select clinical trials is displayed as a percentage of total enrolled participants. When reported, the proportion of Black participants is shown. This analysis was not intended to be a systematic review of all trials meeting specific criteria, but rather a sampling of pivotal trials, many of which supported regulatory approval of the studied device. ^a Further breakdown of racial and ethnic groups was not provided in clinical trial publications.

Figure 3.

A Roadmap for Increasing Enrollment of Underrepresented Populations in Heart Failure Clinical Trials Multilevel strategies and solutions are offered to target the breadth of stakeholders involved in heart failure clinical trials, including patients, supporting communities, sponsors, principal investigators (PIs) and research staff, and regulatory bodies.