Published in:
01-04-2021 | COVID-19 | COVID-19 in Intensive Care
COVID-19 research in critical care: the good, the bad, and the ugly
Published in: Intensive Care Medicine | Issue 4/2021
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The extraordinary pace of research on coronavirus disease 2019 (COVID-19) has been one of the major success stories of the pandemic. Therapeutic trials involving thousands of patients, which usually take years to complete, have been reported in a matter of months. National and international registries and networks have reported on tens of thousands of patients in near real time. However, there have also been many challenges: hundreds of trials have been underpowered, duplicated, or of poor quality; excessive bureaucracy has complicated study initiation; and only a small percentage of eligible patients worldwide have been enrolled in studies, while many others have been treated with off-label, unproven therapies. All of this has been complicated by an “infodemic” of low-quality medical information, accelerated by social media. The goal of the present article is to discuss the challenges, achievements, and future directions of critical care research during the pandemic (Table 1).
Table 1
Demographics and baseline characteristics (open-label safety analysis set)
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What went wrong?
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Solutions
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Small observational studies with highly variable results
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Creation of national or international registries with harmonized data collection for emerging disease outbreaks that are operational both during and outside pandemic periods
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Absence of observational data from outside traditional academic or research centres
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Creation of national or international registries that collect data from all hospitals within a given jurisdiction
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Few observational studies from low- and middle-income countries
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Implementation of national electronic medical record systems in low and middle-income countries to allow for easy (or automated) data collection.
National audits or registries for critical illness
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Too many small clinical trials with inconclusive results
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Avoidance of single centre and single region therapeutic trials
Creation of national or regional ethics review boards
Coordinated data collection between clinical trial networks
Prioritization of large scale multicentre studies as well as collaborations between investigators with overlapping interests
Medical societies to encourage clinical trial participation in place of off-label therapy use
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Too many overlapping/competing clinical trials
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Collaboration across clinical trial networks and funding agencies to ensure fewer, large-scale studies are funded or that small studies work together to generate larger datasets
Prioritization of adaptive platform trials that enable parallel testing of multiple therapeutic options
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Bureaucratic delays in setting up clinical trials
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Fast-track approvals for pandemic-related clinical trials
Creation of national or regional ethics review boards
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Few therapeutic trials in low- and middle-income countries
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Inclusion of low and middle-income countries in international multi-centre clinical trials
Creation of clinical trial networks that include both high- and low-income countries
Simplification of data collection forms
Simplification of trial protocols
Simplification of regulatory requirements for trials using already approved medications
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