Article Text

Download PDFPDF

Fair and equitable subject selection in concurrent COVID-19 clinical trials
Free
  1. Maud O. Jansen1,
  2. Peter Angelos2,
  3. Stephen J. Schrantz1,
  4. Jessica S. Donington3,
  5. Maria Lucia L. Madariaga3,
  6. Tanya L. Zakrison3
  1. 1Medicine, University of Chicago, Chicago, Illinois, USA
  2. 2General Surgery, University of Chicago, Chicago, Illinois, USA
  3. 3Surgery, University of Chicago, Chicago, Illinois, USA
  1. Correspondence to Dr Tanya L. Zakrison, Surgery, University of Chicago, Chicago, IL 60637, USA; tzakrison{at}surgery.bsd.uchicago.edu

Abstract

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.

  • research ethics
  • clinical trials
  • policy guidelines/inst. review boards/review cttes

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage
View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors MOJ wrote the initial draft of the paper. TLZ conducted literature review and drafted the article. PA provided critical review of drafts. MLLM, JSD and SJS provided critical review of drafts and initially proposed the concept for the article.

  • 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.

  • Patient consent for publication Not required.

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

  • Data availability statement There are no data in this work.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.