Design And Analysis Of Vaccine Studies

As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.

Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk. Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule. This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.

Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

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.

This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. 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 statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Recent years have seen an explosion in new kinds of data on infectious diseases, including data on social contacts, whole genome sequences of pathogens, biomarkers for susceptibility to infection, serological panel data, and surveillance data. The Handbook of Infectious Disease Data Analysis provides an overview of many key statistical methods that have been developed in response to such new data streams and the associated ability to address key scientific and epidemiological questions. A unique feature of the Handbook is the wide range of topics covered. Key features Contributors include many leading researchers in the field Divided into four main sections: Basic concepts, Analysis of Outbreak Data, Analysis of Seroprevalence Data, Analysis of Surveillance Data Numerous case studies and examples throughout Provides both introductory material and key reference material

Vaccination programmes are of vital importance to public health and are present in virtually every country in the world. By promoting an understanding of the diverse effects of vaccination programmes, this textbook discusses how epidemiologic methods can be used to study, in real life, their impacts, benefits and risks. Written by expert practitioners in an accessible and concise style, this book is interspersed with practical examples which allow readers to acquire understanding through real-life data and problems. Part I provides an overview of basic concepts in vaccinology, immunology, vaccination programmes, infectious disease transmission dynamics, the various impacts of vaccination programmes and their societal context. Part II covers the main field tools used for the epidemiological evaluation of vaccination programmes: monitoring coverage and attitudes towards vaccination, surveillance of vaccine-preventable diseases and pathogens, seroepidemiological studies, methods to assess impact and outbreak investigation. Part III is dedicated to vaccine effectiveness and its assessment. Part IV includes an overview of the potential risks of vaccination and how to study these. Lastly, Part V deals with methods for an integrated assessment of benefits and risks of vaccination programmes. Suitable for professionals working in public health, epidemiology, biology and those working in health economics and vaccine development, Vaccination Programmes also serves as a textbook for postgraduate students in public health, epidemiology and infectious diseases. The book is aimed at all those involved in the many aspects of vaccination programmes, including public health professionals and epidemiologists. Its primary target audiences are master and doctoral students in infectious disease epidemiology and public health, post-doctoral participants of field epidemiology training programmes and public health professionals working in the post-implementation epidemiological evaluation of vaccines and vaccination programmes. The Open Access version of this book, available at http://www.taylorfrancis.com, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives (CC-BY-NC-ND) 4.0 license