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Diversity in clinical research: public health and social justice imperatives
  1. Tanvee Varma1,
  2. Camara P Jones2,3,
  3. Carol Oladele4,
  4. Jennifer Miller5
  1. 1Yale School of Medicine, New Haven, Connecticut, USA
  2. 2Department of Community Health and Preventive Medicine, Morehouse School of Medicine, Atlanta, Georgia, USA
  3. 3Harvard University Radcliffe Institute for Advanced Study, Cambridge, Massachusetts, USA
  4. 4Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  5. 5Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  1. Correspondence to Dr Jennifer Miller, Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA; jennifer.e.miller{at}yale.edu

Abstract

It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical research is important. This article aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.

Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise.

  • Clinical Trial
  • Ethics- Medical
  • Public Policy

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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Footnotes

  • Twitter @TanveeVarma, @millerbioethics

  • Contributors TV and JM had the original idea of the paper. TV wrote the initial draft of the manuscript with support from JM. All authors (TV, CPJ, CO and JM) were involved in editing the manuscript and producing its final version. JM is responsible for the overall content as guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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