SHEIN-CHUNG CHOW, PhD, is currently Vice President of Biostatistics and Clinical Data Management for Millennium Pharmaceuticals, Inc., in Cambridge, Massachusetts.
JEN-PEI LIU, PhD, is currently Professor of Statistics for the National Cheng kung University in Tainan, Taiwan, and an investigator for the National Health Research Institutes in Taipei, Taiwan. Both authors have extensive background experience in industry and academia, and, collectively, have published well over a dozen books in their respective fields of study.
Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed.
This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.
Watch the author speak about this book at JSM 2012 in San Diego.
Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.
New to the Third Edition
Four new chapters that present a thorough account of novel developments in the field New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies Reorganization of the material into five parts, making it easier to access related information together Over 100 new references from the literature
Like its bestselling predecessors, this edition covers all of the statistical problems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.
This book brings together a broad perspective of new quantitative methods in HIV/AIDS research, contributed by statisticians and mathematicians immersed in HIV research, many of whom are current or previous leaders of CFAR quantitative cores. It is the editors’ hope that the work will inspire more statisticians, mathematicians and computer scientists to collaborate and contribute to the interdisciplinary challenges of understanding and addressing the AIDS pandemic.
The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices.
With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.