From aspects of early trials to complex modeling problems, Advances in Clinical Trial Biostatistics summarizes current methodologies used in the design and analysis of clinical trials. Its chapters, contributed by internationally renowned methodologists experienced in clinical trials, address topics that include Bayesian methods for phase I clinical trials, adaptive two-stage clinical trials, and the design and analysis of cluster randomization trials, trials with multiple endpoints, and therapeutic equivalence trials. Other discussions explore Bayesian reporting, methods incorporating compliance in treatment evaluation, and statistical issues emerging from clinical trials in HIV infection.
Table of Contents
Bayesian Methods for Cancer Phase I Clinical Trials
James S. Babb and André Rogatko
Design of Early Trials in Stem Cell Transplantation: A Hybrid Frequentist-Bayesian Approach
Nancy L. Geller, Dean Follmann, Eric S. Leifer, and Shelly L. Carter
Design and Analysis of Therapeutic Equivalence Trials
Richard M. Simon
Adaptive Two-Stage Clinical Trials
Michael A. Proschan
Design and Analysis of Cluster Randomization Trials
David M. Zucker
Design and Analysis of Clinical Trials with Multiple Endpoints
Nancy L. Geller
Subgroups and Interactions
A Class of Permutation Tests for Some Two-Sample Survival Data Problems
Joanna H. Shih and Michael P. Fay
Bayesian Reporting of Clinical Trials
Simon Weeden, Laurence S. Freedman, and Mahesh Parmar
Methods Incorporating Compliance in Treatment Evaluation
Juni Palmgren and Els Goetghebeur
Analysis of Longitudinal Data with Missingness
Paul S. Albert and Margaret C. Wu
Statistical Issues Emerging from Clinical Trials in HIV Infection
Abdel Babiker and Ann Sarah Walker
"…recommend[ed]….written in a style that explains the methods rather than one that simply trieds to impress you with how clever the authors are."
"Twenty contributions provide a wide range of experience in the discipline…well written, clear and concise...provides an excellent source of reference material...provides interesting reading with new methodology clearly explained…makes an important contribution to the field…figures, tables, examples, summaries, discussions and conclusions are well presented. I liked the useful index of clinical trials and index of abbreviations at the end of the book…examples provide for interesting reading. I recommend this book. It makes a worthwhile addition to any medical science and/or statistics library."
-ISCB News, December 2004
"This book provides excellent survey articles on most commonly used biostatistical tools for clinical research. The articles cover the whole range of clinical research… This book is recommended for biostatistics graduate students and practitioners. I support this recommendation."
"This volume is a collection of 12 excellent chapters by researchers with extensive experience with research in biostatistics. The researchers are knowledgeable with both the underlying theory and the practical difficulties encountered in clinical trials research. The book is a recommended purchase for research libraries."
-Journal of Mathematical Psychology, Vol. 49, 2005
"As a summary of some of the currently most modern approaches to design and analysis, this is a welcome addition for both personal and institutional libraries."
"…contains a dozen research articles by experts illustrating modern (Bayesian and frequentist's) statistical approaches to design and analysis for drug development. …Biostatisticians and clinical scientists will like this book and find it highly useful."
-Journal of Statistical Computation and Simulation, Vol. 75, No. 9, Sept. 2005