This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that must be addressed by statisticians at the design stage. It can assist practitioners in the design of PCTs and serve as a textbook for graduate level biostatistics students.

This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. This book is intended for graduate students, health researchers and data analysts.

This book presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approaches, such as the use of marginal structural models for controlling dynamic selection bias in t

This book provides wide-ranging coverage of parametric modeling in linear and nonlinear mixed effects models. It presents a rigorous approach for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. The book ta

Using real data sets throughout, this text introduces the latest methods for analyzing high-dimensional survival data. With an emphasis on the applications of survival analysis techniques in genetics, it presents a statistical framework for burgeoning research in this area and offers a set of established approaches for statistical analysis. The

Health economics is concerned with the study of the cost-effectiveness of health care interventions. This book provides an overview of Bayesian methods for the analysis of health economic data. After an introduction to the basic economic concepts and methods of evaluation, it presents Bayesian statistics using accessible mathematics. The next ch

Longitudinal studies often investigate how a marker that is repeatedly measured in time is associated with a time to an event of interest. An example is prostate cancer studies where longitudinal PSA level measurements are collected in conjunction with the time-to-recurrence. This book provides a full treatment of joint models for longitudinal a

This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. This edition significantly updates the chapters on p

Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, this volume explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. It describes important multiplicity problems encountered in pre-clinical and clinic

Taking into account the regulatory and scientific developments that have occurred since its predecessor, this third edition presents a comprehensive summary of the ever-expanding literature and research in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and a