How Should We Approach Body Size Diversity in Clinical Trials?

Abstract

Regulatory and ethical considerations mandate that minorities affected by health disparities be included in research. Despite concerns about clinical outcomes for patients with obesity, clinical trials have reported few data about participation of and outcomes for such patients. This article examines the lack of body size diversity in clinical research participants and reviews the evidence and ethical arguments for including larger-bodied patients. Drawing on examples of improved gender diversification of trial participants, this article suggests that similar benefits would be likely from inclusion of body diversity. Diversity in Clinical TrialsClinical trials have historically overrepresented White male participants and underrepresented children and older adults, women, gender and sexually diverse people, and people of color. 1 Given the higher burden of disease among disadvantaged minorities, 1,2,3 their lack of representative inclusion in trials threatens to exacerbate health disparities. 4 Continued disparities in cardiovascular health demonstrate this phenomenon, as women and people of color continue to be underrepresented in clinical trials and thus benefit less from research advances. 5,6