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.
Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach
Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies
Clinical Trial Optimization Using R
Analysis of Incidence Rates
Mani Lakshminarayanan, Fanni Natanegara
August 20, 2019
The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/analyses such as the Bayesian approach are essential to...
Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce
July 18, 2019
Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’...
Harry Yang, Steven Novick
July 09, 2019
Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian...
Iftekhar Khan, Ralph Crott, Zahid Bashir
July 02, 2019
Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few...
Shu Kay Ng, Liming Xiang, Kelvin Kai Wing Yau
May 21, 2019
Mixture Modelling for Medical and Health Sciences provides a direct connection between theoretical developments in mixture modelling and their applications in real world problems. The book describes the development of the most important concepts through comprehensive analyses of real and practical...
Alex Dmitrienko, Erik Pulkstenis
May 12, 2019
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as...
May 12, 2019
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...
Stephen L. George, Xiaofei Wang, Herbert Pang
May 12, 2019
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S....
April 15, 2019
Incidence rates are counts divided by person-time; mortality rates are a well-known example. Analysis of Incidence Rates offers a detailed discussion of the practical aspects of analyzing incidence rates. Important pitfalls and areas of controversy are discussed. The text is aimed at graduate...
Mark Chang, John Balser, Jim Roach, Robin Bliss
March 20, 2019
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development…. Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these...
Elias Moreno, Francisco Jose Vazquez-Polo, Miguel Angel Negrín-Hernández
January 29, 2019
Cost-effectiveness analysis is becoming an increasingly important tool for decision making in the health systems. Cost-Effectiveness of Medical Treatments formulates the cost-effectiveness analysis as a statistical decision problem, identifies the sources of uncertainty of the problem, and gives an...
Satrajit Roychoudhury, Soumi Lahiri
November 21, 2018
Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and...