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COVID-19 meta studies of ivermectin may be amplifying weak research

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International experts, including an Australian, argue that COVID-19 treatment meta-analyses - studies that bring together and re-analyse data from previous studies - are likely to be flawed because the quality of the data in those previous studies is highly variable. They use the example of ivermectin, the current drug du jour for COVID-19 conspiracy theorists, and say they found disparities in the data and other issues in the individual studies included in ivermectin meta-analyses, which were then unintentionally magnified by the meta-analyses. And some studies were included despite the fact that some were so weak they later had to be withdrawn by the publishing journals. The scientists suggest studies should not be included in meta-analyses unless the scientists conducting that meta-analysis have access to data on individual patients from those studies. That should prevent favourable conclusions from weak trials being magnified by meta-analyses and rapidly translated into widespread clinical practice and public policy, they say.

Journal/conference: Nature Medicine

Research: Paper

Organisation/s: The University of New South Wales, St George’s, University of London, UK

Funder: No information provided.

Media release

From: Springer Nature

Correspondence: Flaws in ivermectin data suggest COVID-19 meta-analyses need rethinking

Data from individual patients in clinical trials should be made available by researchers, and then requested and reviewed, for meta-analyses of potential therapeutics for COVID-19, argue Kyle Sheldrick and colleagues in a Correspondence published in Nature Medicine. Using the example of research into the use of ivermectin to highlight the risks inherent in current approaches, the authors contend that immediate remediation is needed in order to prevent potential harm to patients.

The COVID-19 pandemic has resulted in a surge in demand for randomized clinical trials of novel treatments and accompanying meta-analyses — the statistical approach used for the analysis of data from multiple studies. However, relying on low-quality or questionable studies for these analyses in the current global climate could present severe and immediate harm.

Kyle Sheldrick and colleagues draw upon the example of research and meta-analyses into the use of the anti-parasitic drug ivermectin as a prophylactic or treatment for COVID-19. Examining the available evidence, the authors note disparities in original trial data that are then amplified by meta-analyses. These include irregularities, randomization failures and substantial methodological weaknesses, which have led to withdrawal of some of this research. These disparities could in turn affect the reliability of meta-analyses into the effectiveness of the drug against COVID-19.

The authors argue that to counteract these problems, a change is needed in the way that COVID-19 clinical trial data are analyzed. In particular, the authors call for meta-analyses to be published on the basis of data from individual patients. This would include scientists’ requesting and reviewing data at the level of individual patients in all studies, with every clinical trial investigating novel treatments for COVID-19 following best-practice guidelines and making individual-patient-level data available. Any ethical privacy concerns, the authors claim, can be easily addressed with early trial planning and anonymization. Research that does not share individual-patient-level data should be excluded from any meta-analyses.

In this way, Kyle Sheldrick and colleagues emphasize, steps can be taken to prevent any apparent favourable conclusions from relatively weak trials from being rapidly translated into widespread clinical practice and public policy.

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