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. 2021 Apr;18(2):226-233.
doi: 10.1177/1740774520988669. Epub 2021 Feb 2.

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Michelle N Meyer  1 , Luke Gelinas  2 , Barbara E Bierer  3 , Sara Chandros Hull  4 , Steven Joffe  5   6 , David Magnus  7 , Seema Mohapatra  8 , Richard R Sharp  9 , Kayte Spector-Bagdady  10 , Jeremy Sugarman  11 , Benjamin S Wilfond  12 , Holly Fernandez Lynch  5   6
Affiliations

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Michelle N Meyer et al. Clin Trials. 2021 Apr.

Abstract

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution's research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors' experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.

Keywords: COVID-19; clinical trials; coronavirus; prioritization; research ethics; triage.

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Conflict of interest statement

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: S.J. reports grants from Pfizer, outside the submitted work. J.S. reports personal fees and non-financial support from Merck KGaA (Bioethics Advisory Panel and Stem Cell Research Oversight Committee), personal fees and non-financial support from IQVIA (Ethics Advisory Panel), personal fees and other from Aspen Neurosciences Inc (Scientific Advisory Board), personal fees from Biogen, personal fees from Portola Pharmaceuticals, Inc., outside the submitted work.

Figures

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Figure 1. Three stages of COVID-19 trial consolidation and prioritization.
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References

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