BOOK SERIES


Chapman & Hall/CRC Biostatistics Series


About the Series

The primary objectives of the Chapman & Hall/CRC Biostatistics Series are to provide useful reference books for researchers and scientists in academia, industry, and government, and also to offer textbooks for undergraduate and graduate courses in the area of biostatistics and bioinformatics. The book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics and bioinformatics, such as those in biological and biomedical research.

The scope of the series is wide, including applications of statistical methodology in biology, epidemiology, genetics, pharmaceutical science and clinical trials, public health, and medicine. The series is committed to providing easy to understand, state-of-the-art references and textbooks. In each volume, statistical concepts and methodologies will be illustrated through real world examples whenever possible.

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Quantitative Methods for HIV/AIDS Research

Quantitative Methods for HIV/AIDS Research

Forthcoming

Cliburn Chan, Michael G. Hudgens, Shein-Chung Chow
August 25, 2017

Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research;...

Cluster Randomised Trials, Second Edition

Cluster Randomised Trials, Second Edition

Forthcoming

Richard J. Hayes, Lawrence H. Moulton
July 19, 2017

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against...

Clinical Trial Optimization Using R

Clinical Trial Optimization Using R

Forthcoming

Alex Dmitrienko, Erik Pulkstenis
May 16, 2017

The main goal of this book is to define a unified framework for clinical trial optimization based on a comprehensive quantitative evaluation of relevant clinical scenarios (using the clinical scenario evaluation approach) and introduce best practices for simulationbased optimization. The book will...

Clinical Trial Data Analysis Using R and SAS, Second Edition

Clinical Trial Data Analysis Using R and SAS, Second Edition

Forthcoming

Ding-Geng (Din) Chen, Karl E. Peace, Pinggao Zhang
May 05, 2017

This book will provide a thorough presentation of clinical trial methodology with detailed step-by-step illustrations on implementation in software R/SAS. The examples will be based on actual experience of the authors in many areas of clinical drug development. Actual examples of clinical trials...

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials

Toshiro Tango
February 16, 2017

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The...

Methods in Comparative Effectiveness Research

Methods in Comparative Effectiveness Research

Constantine Gatsonis, Sally C. Morton
February 07, 2017

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that...

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD
January 17, 2017

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in...

Bioequivalence and Statistics in Clinical Pharmacology, Second Edition

Bioequivalence and Statistics in Clinical Pharmacology, Second Edition

Scott D. Patterson, Byron Jones
December 20, 2016

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and...

Data and Safety Monitoring Committees in Clinical Trials, Second Edition

Data and Safety Monitoring Committees in Clinical Trials, Second Edition

Jay Herson
December 13, 2016

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young...

Applied Surrogate Endpoint Evaluation Methods with SAS and R

Applied Surrogate Endpoint Evaluation Methods with SAS and R

Ariel Alonso, Theophile Bigirumurame, Tomasz Burzykowski, Marc Buyse, Geert Molenberghs, Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, Wim Van der Elst
December 08, 2016

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate...

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Craig Mallinckrodt, Ilya Lipkovich
December 06, 2016

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provide practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice. This book, with its example-oriented approach that includes numerous SAS and R code...

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Harry Yang
December 01, 2016

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and...

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