Chapman & Hall/CRC Biostatistics Series
About the Book Series
The primary objectives of the 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 areas 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.
Please contact us if you have an idea for a book for the series.
Advanced Statistics in Regulatory Critical Clinical Initiatives
1st Edition
Edited
By Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow
May 27, 2024
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on ...
Statistical Methods for Mediation, Confounding and Moderation Analysis Using R and SAS
1st Edition
By Qingzhao Yu, Bin Li
May 27, 2024
Third-variable effect refers to the effect transmitted by third-variables that intervene in the relationship between an exposure and a response variable. Differentiating between the indirect effect of individual factors from multiple third-variables is a constant problem for modern researchers. ...
Statistical Thinking in Clinical Trials
1st Edition
By Michael A. Proschan
May 27, 2024
Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and ...
Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations
1st Edition
Edited
By Avery McIntosh, Oleksandr Sverdlov
May 23, 2024
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into ...
Bayesian Precision Medicine
1st Edition
By Peter F. Thall
May 07, 2024
Bayesian Precision Medicine presents modern Bayesian statistical models and methods for identifying treatments tailored to individual patients using their prognostic variables and predictive biomarkers. The process of evaluating and comparing treatments is explained and illustrated by practical ...
Value of Information for Healthcare Decision-Making
1st Edition
Edited
By Anna Heath, Natalia Kunst, Christopher Jackson
February 08, 2024
Value of Information for Healthcare Decision-Making introduces the concept of Value of Information (VOI) use in health policy decision-making to determine the sensitivity of decisions to assumptions, and to prioritise and design future research. These methods, and their use in cost-effectiveness ...
Probability Modeling and Statistical Inference in Cancer Screening
1st Edition
By Dongfeng Wu
February 06, 2024
Cancer screening has been carried out for six decades – however, there are many unsolved problems: how to estimate key parameters involved in screenings, such as sensitivity, the time duration in the preclinical state (i.e., sojourn time), and time duration in the disease-free state; how to ...
Confidence Intervals for Discrete Data in Clinical Research
1st Edition
By Vivek Pradhan, Ashis Gangopadhyay, Sandeep M. Menon, Cynthia Basu, Tathagata Banerjee
January 29, 2024
Confidence Intervals for Discrete Data in Clinical Research is designed as a toolbox for biomedical researchers. Analysis of discrete data is one of the most used yet vexing areas in clinical research. The array of methodologies available in the literature to address the inferential questions for ...
Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches
1st Edition
Edited
By William Wang, Melvin Munsaka, James Buchanan, Judy Li
January 29, 2024
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual ...
Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17
1st Edition
Edited
By Gang Li, Bruce Binkowitz, William Wang, Hui Quan, Josh Chen
January 29, 2024
Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from ...
Case Studies in Innovative Clinical Trials
1st Edition
Edited
By Kristine Broglio, Binbing Yu
November 27, 2023
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases....
Methodologies in Biosimilar Product Development
1st Edition
Edited
By Sang Joon Lee, Shein-Chung Chow
September 25, 2023
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval...