A recent conference at the New Jersey Institute of Technology generated these 15 review articles, papers describing applications of cutting edge statistical methodology, and reports of new methods and
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health a
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
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 de
Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at a
This book focuses on clinical trial design and monitoring with time-to-event endpoints. Detail of subjects of the book are included in book contents. This book not only provides a comprehensive review
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
Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these method
This book will cover critical topics in quantitative methods that are commonly encountered in HIV/AIDS research, such as management of laboratory data, biomarker discovery in vaccine trials and safety
Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adapt
This is the second edition of a popular reference on cluster randomized trials. There have been many developments in methodology and applications since the first edition published in 2007. The second
There are many methods for multiple testing adjustment and questions arise concerning when they should be used and how they may provide different results. This book focuses on multiple testing methods
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
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 experien
Missing data in longitudinal clinical trials has justifiably been the target of considerable research. However, missing data is just one of the many considerations in the analysis of longitudinal data
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
Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs
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-
This book provides an overview of key statistical topics in clinical pharmacology, with a particular emphasis on bioequivalence. It adopts a very practical approach, with lots of real examples and sof
Biclustering is a data-mining technique that allows simultaneous clustering of rows and columns within a matrix. This book focuses on biclustering as an unsupervised learning method for high-dimension
This book provides an overview of statistical methods for measuring and monitoring healthcare performance. It covers the purpose of monitoring, data sources, types of measures for quality and safety o
This book provides a comprehensive and state-of-the-art overview of benefit-risk assessment methods in drug development. Unlike other books which focus mainly on qualitative benefit-risk assessments,
Bayesian methods are particularly useful in early-phase dose-finding trials because they allow investigators to incorporate prior information into dose finding, improving efficiency and accuracy of th
Multi-regional clinical trials are often conducted as a single trial focusing on overall results. However, when such trials are submitted to health authorities, the scope and concern may broaden to in
In the development of statistics, models for the analysis of longitudinal data took a particularly important place, especially in biostatistics. This book describes methods available for applied stati
A comprehensive overview of how to scientifically evaluate of traditional Chinese medicines(TCMs), this book covers regulatory requirements, statistical design, and data analysis for studies conducted
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. U
