Meta‐analysis of clinical trials with rare events

Dankmar Böhning · Kalliopi Mylona · Alan Kimber

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Statistical Methods in Epidemiology

Abstract

Meta-analysis of rare event studies has recently become a subject of controversy and debate. We will argue and demonstrate in this paper that the occurrence of zero events in clinical trials or cohort studies, even if zeros occur in both arms (the case of a double-zero trial), is less problematic, at least from a statistical perspective, if the available statistical tools are applied in the appropriate way. In particular, it is neither necessary nor advisable to exclude studies with zero events from the meta-analysis. In terms of statistical tools, we will focus here on Mantel-Haenszel techniques, mixed Poisson regression and related regression models.

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References

2004What to add to nothing? Use and avoidance of continuity corrections in meta‐analysis of sparse data 2010Random effects meta-analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data 2007Inclusion of zero total event trials in meta-analyses maintains analytic consistency and incorporates all available data 2008Why add anything to nothing? The arcsine difference as a measure of treatment effect in meta‐analysis with zero cells 2012Meta-Analysis of Rare Binary Adverse Event Data 2008Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction 2010Meta-analysis for rare events 2007Fixed vs random effects meta‐analysis in rare event studies: The Rosiglitazone link with myocardial infarction and cardiac death

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2018Methods for evidence synthesis in the case of very few studies 2018A comparison of seven random‐effects models for meta‐analyses that estimate the summary odds ratio 2018When should meta‐analysis avoid making hidden normality assumptions?2019Random‐effects meta‐analysis of few studies involving rare events

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