ome racial and ethnic populations, particularly Black and Hispanic individuals, have a greater burden of heart failure (HF), are less likely to receive optimal disease-modifying therapies, and are more likely to die from HF. [1][2][3][4][5] Despite this excess risk, these same populations are often the least studied in HF clinical trials. [6][7][8][9][10] The importance of addressing the systemic underenrollment of some racial and ethnic groups has been previously highlighted 11 and remains an important directive of the US Food and Drug Administration (FDA) Safety and Innovation Act as well as the Inclusion Policy of the National Institutes of Health (NIH). 12 The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance therapeutic development and delivery to patients with HF, 13 has been dedicated to improving recruitment strategies for diverse patient populations. This article is the direct result of virtual and in-person discussions among Collaboratory stakeholders with the goal of proposing strategies to improve enrollment in HF clinical trials of underrepresented racial and ethnic groups. We focus on the US perspective in the HF clinical trial landscape (with specific attention to enrollment of Black and Hispanic participants) and highlight US federal policies and initiatives to promote improved racial and ethnic representation. We recognize the need as well for improving enrollment of other populations of interest, including women, older adults, and people in rural areas of the United States [14][15][16][17] ; however, this call to action focuses on building sustainable pathways to improve future diverse participation with respect to race and ethnicity.
Barriers in Underrepresented HF Trial EnrollmentMany racial and ethnic populations continue to experience socioeconomic deprivation, chronic discrimination, and stress that worsen health outcomes across the lifespan. [18][19][20][21] The ability and willingness of patients with HF to actively participate in clinical trials is intricately tied to social determinants of health, such as access to health care, education, income equality, and food security as well as cultural and community values. 22 This underrepresentation likely results from limited access both to clinical care and the current clinical 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 i...