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.
Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials
Analysis of Incidence Rates
Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials
Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R
Bayesian Methods for Repeated Measures
Mark Chang, John Balser, Robin Bliss, Jim Roach
February 28, 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...
February 28, 2019
This book clarifies what incidence rates are, reviews their advantages and limitations, promotes understanding of analytic methods, describes what can be done in modern software, provides practical suggestions for analyses, and points out problems and pitfalls. Stata commands that can recreate the...
Elias Moreno, Francisco Jose Vazquez-Polo, Miguel Angel Negrin-Hernandez
February 06, 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 23, 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...
Zoran Antonijevic, Robert A. Beckman
November 21, 2018
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly...
Jie Chen, Joseph Heyse, Tze Leung Lai
September 10, 2018
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in...
June 18, 2018
Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with...
Lyle D. Broemeling
June 01, 2018
Analyze Repeated Measures Studies Using Bayesian Techniques Going beyond standard non-Bayesian books, Bayesian Methods for Repeated Measures presents the main ideas for the analysis of repeated measures and associated designs from a Bayesian viewpoint. It describes many inferential methods for...
Paddy Farrington, Heather Whitaker, Yonas Ghebremichael Weldeselassie
May 02, 2018
Self-Controlled Case Series Studies: A Modelling Guide with R provides the first comprehensive account of the self-controlled case series (SCCS) method, a statistical technique for investigating associations between outcome events and time-varying exposures. The method only requires information...
Ariel Alonso, Theophile Bigirumurame, Tomasz Burzykowski, Marc Buyse, Geert Molenberghs, Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, Wim Van der Elst
December 13, 2017
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...
Abhaya Indrayan, Rajeev Kumar Malhotra
December 06, 2017
Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. This edition includes more topics in order to fill...
Demissie Alemayehu, PhD, Joseph C. Cappelleri, PhD, Birol Emir, PhD, Kelly H. Zou, PhD, Pstat
November 28, 2017
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to...