Overview
- Offers a comprehensive guide to the current state of statistical methods for clinical vaccine trials
- Shares key insights into the analysis of vaccine field studies, including observational ones
- Features a wealth of worked-out real-world examples
- Provides SAS codes
Part of the book series: Springer Series in Pharmaceutical Statistics (SSPS)
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Table of contents (12 chapters)
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Front Matter
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The Interplay Between Microorganisms and the Immune System
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Front Matter
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Analysis of Immunogenicity Data
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Front Matter
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Vaccine Field Studies
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Front Matter
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Correlates of Protection
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Front Matter
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Analysis of Vaccine Safety Data
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Front Matter
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Back Matter
Keywords
About this book
This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward.
This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data.
In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies.
The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.
Authors and Affiliations
About the author
Jozef Nauta is a principal statistician, with more than 25 years of experience in the pharmaceutical industry, and with special interest in the development of influenza vaccines. During his career he has published numerous journal articles on statistics and vaccines. He currently participates in Development of Robust and Innovative Vaccine Effectiveness (DRIVE), a public private partnership that advances European cooperation in influenza vaccine effectiveness studies, funded by, amongst others the Innovative Medicines Initiative (IMI). He lives with his wife and son in Amsterdam, the Netherlands.
Bibliographic Information
Book Title: Statistics in Clinical and Observational Vaccine Studies
Authors: Jozef Nauta
Series Title: Springer Series in Pharmaceutical Statistics
DOI: https://doi.org/10.1007/978-3-030-37693-2
Publisher: Springer Cham
eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)
Copyright Information: Springer Nature Switzerland AG 2020
Hardcover ISBN: 978-3-030-37692-5Published: 15 March 2020
Softcover ISBN: 978-3-030-37695-6Published: 15 March 2021
eBook ISBN: 978-3-030-37693-2Published: 14 March 2020
Series ISSN: 2366-8695
Series E-ISSN: 2366-8709
Edition Number: 2
Number of Pages: XXII, 234
Number of Illustrations: 10 b/w illustrations
Topics: Statistics for Life Sciences, Medicine, Health Sciences, Vaccine, Biostatistics, Statistical Theory and Methods, Pharmaceutical Sciences/Technology, Immunology