Reporting and representation of ethnic minorities in cardiovascular trials: a systematic review

Ethnic minority groups in the United States are at increased risk of developing cardiovascular diseases, experiencing adverse outcomes, and receiving suboptimal treatment. Such discrepancies may be related to a difference in race-specific outcomes in the management of cardiovascular diseases. However, little is known about the reporting and representation of ethnic minorities in major cardiovascular trials.

A systematic review of major cardiovascular randomized controlled trials published in The Journal of the American Medical Association, The Lancet, and The New England Journal of Medicine between 1997 and 2010 was performed. We determined the reporting rate of the following ethnic minority groups in studies that enrolled American patients: whites, African Americans, Asians, and Hispanics.

A total of 250 randomized controlled trials that enrolled 1,103,694 patients were included in the systematic review. Among them, 56% (n = 140) of the trials reported information on race. No significant temporal changes in racial reporting were observed during the study period (P = .21). The median enrollment rate in trials for whites, African Americans, Hispanics, and Asians was 86%, 7%, 6%, and 4%, respectively. When compared with the population prevalence of disease burden, we found that whites were overrepresented (88% vs 78%, P < .001), whereas African Americans were underrepresented (3% vs 11%, P < .001), in trials of coronary artery disease.

Despite significant changes in the ethnic composition of the United States, we found that only about half of all major cardiovascular trials reported any racial information. Underrepresentation of ethnic minority groups in cardiovascular trials was observed.