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The ethics of COVID-19 treatment studies: too many are open, too few are double-masked

covid 19 shidonna raven garden and cook

June 30, 2020

Jeffrey K Aronson, Nicholas DeVito, Robin E Ferner*†, Kamal R Mahtani, David Nunan, Annette Plüddemann 

On behalf of the Oxford COVID-19 Evidence Service Team
Source: Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences
University of Oxford

Correspondence to jeffrey.aronson@phc.ox.ac.uk

*University of Birmingham University College London

Summary
A WHO panel, convened during the 2014 Ebola virus epidemic, assessed the ethical implications of using medicines that have shown promising results in the laboratory and in animal models, but before they have been evaluated for safety and efficacy in humans. They concluded that researchers have a moral duty to evaluate unproven interventions (for treatment or prevention) in clinical trials that are of the best possible design in exceptional circumstances. Circumstances such as apply today.

In our view, the description “clinical trials that are of the best possible design”, where therapeutic interventions are concerned, implies adequately masked randomized controlled trials.

But more trials of pharmacological interventions are being conducted in the treatment of COVID-19 without blinding (or masking) of interventions than are being conducted masked. Some single-blind trials mask only the participant rather than the investigator. A minority are placebo-controlled. Trials of non-pharmacological interventions are being even less well served, relying largely on retrospective studies and mathematical models of uncertain value.

We believe this to be a potential waste of participants’ and investigators’ time and therefore unethical. Biased results can distort therapeutic decision-making, public perceptions, investment in healthcare, and the standing and value of medical research. They may falsely suggest a lack of equipoise, discouraging investigators from performing well designed clinical trials and make recruitment to such trials difficult. They may result in more harms than benefits.

The example of the RECOVERY trial shows that it is possible to carry out large-scale high-quality clinical trials that yield reliable and useful results in a completely ethical framework.

Are you willing to be apart of a COVID 19 clinical trail? Why? Why not?

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