Clinical Ethics 17 (1):95-104 (2022)

Abstract
Coronavirus disease 2019 is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, despite a lack of evidence of efficacy in COVID-19. In this review, we highlight the potential ethical issues that should be addressed during the use of investigational drugs with little prior evidence as a treatment options during a pandemic. We discuss the impact of design of randomized clinical trials using LOTUS trial as an example and that of off-label use of drugs like chloroquine/hydroxychloroquine on the safety of patients during COVID-19. We conclude that the adaptive randomized clinical trial designs offer a flexible and efficient approach, enabling patients to quickly switch to successful treatments, while minimizing the number of patients on standard of care. Randomized clinical trial design should consider blinding of investigators and only representative patients who can provide consent should be included. We also conclude the emergency approvals of drugs should be carefully issued and off-label use should be restricted in pandemics. Streamlined regulatory guidelines for emergency drug use in a pandemic can also help in providing benefit and minimizing harm to patients in the future.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1177/14777509211011431
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 70,214
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

The Ethics of Single Blind Trials.Paul S. Heckerling - 2005 - IRB: Ethics & Human Research 27 (4):12.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

Science and Behavior.Robert Silbergleit & Peter A. Ubel - 2011 - American Journal of Bioethics 11 (2):W1 - W2.

Analytics

Added to PP index
2021-04-28

Total views
7 ( #1,068,020 of 2,507,566 )

Recent downloads (6 months)
1 ( #416,983 of 2,507,566 )

How can I increase my downloads?

Downloads

My notes