General Science and Philosophy

    

Modeling Bias in Vaccine Trials Relying on Fragmented Healthcare Records

Authors: Peter J. Yim

COVID-19 vaccine trials depend on the localization of vaccination records for each trial subject. Misclassification bias occurs when vaccination records cannot be localized or uniquely identified. This bias may be significant in trials where the trial subjects’ vaccination and health records are distributed between more than one database. The potential for this bias is present in numerous published COVID-19 vaccine trials. A model is proposed for estimation of the magnitude of this bias on apparent vaccine efficacy. In the model, misclassification is always in the direction from partial or fully vaccinated status to unvaccinated status. The model predicts a disproportionate effect of vaccination status misclassification on the apparent vaccine efficacy when population vaccination rates are high.

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Submission history

[v1] 2023-01-21 02:25:45

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