Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of 'compassionate therapies' in times of catastrophic pandemics. Issue 12 (13th October 2021)

• Record Type: Journal Article
• Authors: Zuckerman, Shlomit; Barlavie, Yaron; Niv, Yaron; Arad, Dana; Lev, Shaul
• Is Part Of: Journal of medical ethics. Volume 48:Issue 12(2022)
• Page Start: 1000
• Page End: 1005
• Publication Date: 2021-10-13
• Subjects: clinical trials -- research ethics -- public health ethics -- policy guidelines/inst. review boards/review cttes -- drugs and drug industry; Medical ethics -- Periodicals; 174.2
• DOI: 10.1136/medethics-2020-106783
• Languages: English
• ISSNs: 0306-6800

Abstract

Abstract : 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.