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Significant lack of women and minorities involved in clinical trials for cardiometabolic medication, research shows

Published on 01/06/20 at 12:07pm

Women and minorities, particularly African Americans, continue to be under represented in clinical trials for cardiometabolic medication, according to a new study.

Research published in the Journal of the American Heart Association, an open-access journal, showed that this trend was unlikely to be changed in the coming years.

This analysis showed that from 2008-2017 women accounted for 36% of trial participants, 4% were black/African American, 12% were Asian and 11% were Hispanic/Latino.

Dr Muhammed Shahzeb Khan, resident in internal medicine at John H Stroger Jr Hospital of Cook County in Chicago said: “Demographics characteristics, such as race and gender, may have contrasting effects on medication response, which may inadvertently lead to variation in treatment outcomes and survival.

“Unfortunately, we found that the enrollment of women and racial minorities has remained disproportionately low. The disparities in gender, race and ethnicity of participants in major clinical trials may have significant implications in determining the effects of these therapies in these groups and may impair generalizability of trial results to routine clinical practice.”

In 1993, the FDA established guidelines to increase the diversity of clinical trials, but this study reinforces the need to increase the representation of all demographic subgroups to ensure variations in outcomes of both benefits and safety.

Conor Kavanagh

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