Fair and equitable subject selection in concurrent COVID-19 clinical trials.
J Med Ethics
; 47(1): 7-11, 2021 01.
Article
in English
| MEDLINE | ID: covidwho-1066922
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Patient Selection
/
COVID-19
Type of study:
Prognostic study
/
Randomized controlled trials
/
Systematic review/Meta Analysis
Limits:
Humans
Language:
English
Journal:
J Med Ethics
Year:
2021
Document Type:
Article
Affiliation country:
Medethics-2020-106590
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