The design and analysis of vaccine trials for COVID-19 for the purpose of estimating efficacy

Stephen Senn

doi:10.1002/pst.2226

The design and analysis of vaccine trials for COVID-19 for the purpose of estimating efficacy

Stephen Senn^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

6 Citations (Scopus)

Abstract

After a preliminary explanation as to how I came to know Andy Grieve and some remarks about his career and mine and how they have intersected, I consider the design and analysis of trials of vaccines for COVID-19 for the purpose of estimating efficacy. Five large trials, run by the sponsors Pfizer/BioNTech, AstraZeneca/Oxford University, Moderna, Novavax and J&J Janssen are considered briefly. Frequentist approaches to analysis were used for four of the trials but Pfizer/BioNTech nominated a Bayesian approach. The design and analysis of this trial is considered in some detail, in particular as regards the choice of prior distribution. I conclude by drawing some general lessons.

Original language	English
Pages (from-to)	790-807
Number of pages	18
Journal	Pharmaceutical Statistics
Volume	21
Issue number	4
DOIs	https://doi.org/10.1002/pst.2226
Publication status	Published - 1 Jul 2022
Externally published	Yes

Keywords

Bayesian
conditional inference
design of experiments
frequentist
sequential design
vaccine efficacy

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10.1002/pst.2226

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AB - After a preliminary explanation as to how I came to know Andy Grieve and some remarks about his career and mine and how they have intersected, I consider the design and analysis of trials of vaccines for COVID-19 for the purpose of estimating efficacy. Five large trials, run by the sponsors Pfizer/BioNTech, AstraZeneca/Oxford University, Moderna, Novavax and J&J Janssen are considered briefly. Frequentist approaches to analysis were used for four of the trials but Pfizer/BioNTech nominated a Bayesian approach. The design and analysis of this trial is considered in some detail, in particular as regards the choice of prior distribution. I conclude by drawing some general lessons.

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The design and analysis of vaccine trials for COVID-19 for the purpose of estimating efficacy

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Keywords

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