Fair and equitable subject selection in concurrent Covid-19 clinical trials

Bibliographic Data

ID21515420
AuthorsMaud O Jansen (0000-0002-0659-4298, University of Chicago), Peter Angelos (0000-0001-6779-8342, University of Chicago), Stephen J Schrantz, Stephen Schrantz (University of Chicago), Jessica S Donington, Jessica Donington (0000-0003-3760-7327, University of Chicago), Maria Lucia L Madariaga (0000-0002-2950-7230, University of Chicago), Tanya L Zakrison (0000-0001-6061-431X, University of Illinois Chicago, corresponding author)
Year2021
Volume47
Issue1
Pages7-11
Publication date2021-01-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueJournal of Medical Ethics (JOURNAL)
Journal identifiersISSN: 0306-6800 • E-ISSN: 1473-4257
PublisherBMJ (PUBLISHER • GB)
DOI10.1136/medethics-2020-106590
PMID33046590
OpenAlexW3092089696
LanguageEN
Citations received2
References cited13

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

Actuarial science · Alternative medicine · Business · Clinical study design · Clinical trial · Disease · Pandemic · Pathology · Political science · Population · Biomedical Ethics and Regulation · Computer Science · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Law · Medicine

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