TY - JOUR
T1 - Accessing unproven interventions in the COVID-19 pandemic
T2 - discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics
AU - Zuckerman, Shlomit
AU - Barlavie, Yaron
AU - Niv, Yaron
AU - Arad, Dana
AU - Lev, Shaul
N1 - Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/12
Y1 - 2022/12
N2 - Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic.
AB - Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic.
UR - http://www.scopus.com/inward/record.url?scp=85130372672&partnerID=8YFLogxK
U2 - 10.1136/medethics-2020-106783
DO - 10.1136/medethics-2020-106783
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C2 - 34645620
AN - SCOPUS:85130372672
SN - 0306-6800
VL - 48
SP - 1000
EP - 1005
JO - Journal of Medical Ethics
JF - Journal of Medical Ethics
IS - 12
ER -