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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 540-548 |
| Number of pages | 9 |
| Journal | JAMA cardiology |
| Volume | 7 |
| Issue number | 5 |
| DOIs | |
| State | Published - May 2022 |
Funding
employee of Abbott. Dr Batchelor has received consulting fees from Boston Scientific, Medtronic, V-Wave, Abbott, and Idorsia and has received research support from Abbott and Boston Scientific. Dr George is a current employee for Regeneron, was a former employee of AstraZeneca at the time of this work, and holds stock in AstraZeneca. Dr Ibrahim has received honoraria from Novartis and Roche. Dr Jessup is employed by the American Heart Association. Dr Kitzman has received consulting and/or research support from Bayer, Boehringer Ingelheim, Merck, AstraZeneca, Abbvie, Novartis, Corvia, Novo Nordisk, Rivus, Keyto, Pfizer, Duke Clinical Research Institute, and National Institutes of Health and holds stock in Gilead. Dr Psotka is an employee of the Food and Drug Administration and has received personal fees from Amgen, Cytokinetics, and Windtree. Dr Senatore is an employee of the Food and Drug Administration. Dr Stein is an employee of and shareholder in Boston Scientific. Dr Teerlink has received research support from and is a consultant for Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, EBR Systems, Medtronic, Merck, Novartis, scPharma, and Windtree Therapeutics. Dr Yancy reported spousal salary support, Abbott Labs. Dr Lindenfeld has received consulting and/or research support and/or personal fees from Abbott, Alleviant, AstraZeneca, Boehringer Ingelheim, Boston Scientific, CVRx, Edwards Lifesciences, Impulse Dynamics, Sensible Medical, V-Wave, Vifor, and Volumetrix. Dr O’Connor reported serving as a consultant for Bayer, Merck, and Abiomed. Dr Vaduganathan has received research grant support or served on advisory boards for American Regent, Amgen, AstraZeneca, Bayer, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, and Sanofi and speaker engagements with Novartis and Roche Diagnostics and participates on clinical endpoint committees for studies sponsored by Bayer, Galmed, Novartis, Occlutech, and Impulse Dynamics. No other disclosures were reported.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine