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.
Edited
By Harry Yang, Binbing Yu
August 29, 2022
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and ...
Edited
By Kelly H. Zou, Lobna A. Salem, Amrit Ray
August 03, 2022
Real-world evidence is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. Real-World Evidence in ...
By Demissie Alemayehu, Birol Emir, Michael Gaffney
August 01, 2022
With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug ...
By Trevor F. Cox
June 23, 2022
Cancer is a dreaded disease. One in two people will be diagnosed with cancer within their lifetime. Medical Statistics for Cancer Studies shows how cancer data can be analysed in a variety of ways, covering cancer clinical trial data, epidemiological data, biological data, and genetic data. It ...
By Andrew P. Grieve
June 20, 2022
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to ...
By Shein-Chung Chow
May 30, 2022
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because ...
By Weichung Joe Shih, Joseph Aisner
October 26, 2021
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, ...
By Harry Yang, Steven Novick
September 30, 2021
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 ...
By Mark Chang
May 05, 2020
Artificial Intelligence for Drug Development, Precision Medicine, and Healthcare covers exciting developments at the intersection of computer science and statistics. While much of machine-learning is statistics-based, achievements in deep learning for image and language processing rely on computer ...
Edited
By Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger
April 27, 2020
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian ...
By Nusrat Rabbee
April 01, 2020
The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into ...
By Craig Mallinckrodt, Geert Molenberghs, Ilya Lipkovich, Bohdana Ratitch
February 10, 2020
The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using ...