Underrepresented Racial and Ethnic Populations in Heart Failure Trials

Authors:
DeFilippis EM, Echols M, Adamson PB, et al.
Citation:
Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory. JAMA Cardiol 2022;Mar 23:[Epub ahead of print].

The following are key points to remember from this Heart Failure Collaboratory Call to Action on improving enrollment of underrepresented racial and ethnic populations in heart failure trials:

  1. Underrepresentation of Black and Hispanic individuals 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.
  2. The National Institutes of Health (NIH) has established the UNITE initiative to address structural racism within the scientific community. UNITE is a multidisciplinary effort comprised of five committees with interlinked but related goals of promoting excellence in diversity, equity, and inclusion. These committees seek to understand stakeholder experiences; promote research on health disparities; improve NIH culture; ensure transparency and clear communication; and identify changes in practice, policy, and structures.
  3. Strategies to improve clinical trial enrollment of underrepresented populations are centered on three themes: 1) research study design and site selection; 2) patient, institution, and community engagement; and 3) changing the research paradigm.
  4. Recruitment and enrollment strategies during research study design and site selection include minimal inclusion and exclusion criteria, capping enrollment for overrepresented groups, flexibility in participation hours (for patients with work hour limitations), bilingual or multilingual staff and study materials, alleviating barriers to trial participation (i.e., transportation, consolidate research visit with medical clinic visits, follow-up by phone or at home when possible), intentional hiring of investigators and research staff of Alaska Native, American Indian, Black, Hispanic, Native Hawaiian, and other Pacific Islander backgrounds, and global site selection initiatives with increased sites in North America, Africa, and South America.
  5. Recruitment and enrollment strategies during patient, institution, and community engagement include partnership with community entities (i.e., churches, barbershops, community centers); research staff participation in health fairs; speaking engagements; visibility of research team and efforts (marketing and advertising); education for clinic staff and professionals; pretrial evaluations of implementation barriers (i.e., clinic flow, feasibility, evaluation of potential recruitment population); financial support for staff and clinician time; study follow-up results provided to clinic and staff; and access to the medical therapy for all clinical trial participants after study (if beneficial).
  6. Improving recruitment and enrollment strategies by changing the research paradigm include incentives from government agencies, deliberate targets by sponsors, and efforts supported by professional societies and guideline statements.
  7. Industry sponsorship of programs to increase clinical trial diversity can also play a significant role in addressing underrepresented trial leadership and recruitment.
  8. The support of cardiovascular societal organizations is essential to changing the research paradigm, through increasing underrepresented researchers and trial participants. The Faculty Institutional Recruitment for Sustainable Transformation initiative through the NIH aspires to enhance diversity and inclusion among biomedical faculty.
  9. The authors suggest being deliberate in trial design and processes to effect change. These strategies include methodical study design and site selection, diversification of research leadership and staff, careful review of eligibility criteria, community and patient engagement, and broad stakeholder commitment.

Perspective: Kudos to these authors for this outstanding, ‘tour-de-force’ document; a great roadmap to enhance recruitment of minorities in heart failure clinical trials.

Clinical Topics: Cardiovascular Care Team, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure

Keywords: Africa, African Americans, Ambulatory Care, Clinical Trials as Topic, Cultural Diversity, Financial Support, Geriatrics, Government Agencies, Health Fairs, Heart Failure, Hispanic Americans, Leadership, Minority Groups, National Institutes of Health (U.S.), Oceanic Ancestry Group, Patient Selection, Secondary Prevention, Racism, Work Engagement


< Back to Listings