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如何在临床试验中应对体型多样性问题?

How Should We Approach Body Size Diversity in Clinical Trials?

机构信息

Fourth-year medical student at the University of Southern California Keck School of Medicine in Los Angeles.

Assistant professor at the University of Denver in Colorado.

出版信息

AMA J Ethics. 2023 Jul 1;25(7):E517-527. doi: 10.1001/amajethics.2023.517.

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.

摘要

监管和伦理方面的考虑要求将受健康差异影响的少数群体纳入研究。尽管人们对肥胖患者的临床结果存在担忧,但临床试验报告的此类患者的参与情况和结果数据很少。本文探讨了临床研究参与者中缺乏身体大小多样性的问题,并回顾了纳入更大体型患者的证据和伦理论点。本文通过举例说明了临床试验参与者中性别多样化的改善情况,提出了纳入身体多样性可能会带来类似的好处。

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