What is it about?

This is a contribution to a festschrift in honour of the important pharmaceutical statistician Andy Grieve. It describes design and analysis issues in clinical trials for five vaccine development programmes for COVID. Particular attention is paid to the design of a large trials in support of the Pfizer/BioNTech vaccine.

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Why is it important?

Attention is drawn to important similarities and differences between the five development programmes. Bayesian and frequentist approaches to the Pfizer/BioNTech vaccine are compared. A remarkable result is how close one can get to the results of the full planned analyses of the five sponsors just by using simple summary data.

Perspectives

Andy Grieve is a good friend of mine who worked for Pfizer at one time. The coincidence of the COVID pandemic and his 70th is the inspiration for this article. I had had little involvement with vaccine trials and it was a surprise to me how close one could get to the analyses of the sponsors using summary data only.

Professor Stephen J Senn
Consultant Statistician

Read the Original

This page is a summary of: The design and analysis of vaccine trials forCOVID‐19 for the purpose of estimating efficacy, Pharmaceutical Statistics, July 2022, Wiley,
DOI: 10.1002/pst.2226.
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