Article Text
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.
- clinical trials
- research ethics
- public health ethics
- policy guidelines/inst. review boards/review cttes
- drugs and drug industry
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study. No datasets generated or analysed for this study.
This article is made freely available for personal use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.
https://bmj.com/coronavirus/usageStatistics from Altmetric.com
Read the full text or download the PDF:
Other content recommended for you
- The Ebola clinical trials: a precedent for research ethics in disasters
- WHO guidance on ethics in outbreaks and the COVID-19 pandemic: a critical appraisal
- If it walks like a duck…: Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is research
- Building a new platform to support public health emergency response in Africa: the AFENET Corps of Disease Detectives, 2018–2019
- Managing enduring public health emergencies such as COVID-19: lessons from Uganda Red Cross Society’s Ebola virus disease response operation
- Hydroxychloroquine and COVID-19: critiquing the impact of disease public profile on policy and clinical decision-making
- The cost of public health interventions to respond to the 10th Ebola outbreak in the Democratic Republic of the Congo
- Investing in preparedness for rapid detection and control of epidemics: analysis of health system reforms and their effect on 2021 Ebola virus disease epidemic response in Guinea
- Prevalence and risk factors of depression symptoms among rural and urban populations affected by Ebola virus disease in the Democratic Republic of the Congo: a representative cross-sectional study
- Risk communication and community engagement capacity in the Eastern Mediterranean Region: a call for action