Statistical Monitoring of Clinical Trials A Unified Approach

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes

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M. Gail, K. Krickeberg, J. Samet, A. Tsiatis, W. Wong

Statistics for Biology and Health Borchers/Buckland/Zucchini: Estimating Animal Abundance: Closed Populations. Burzykowski/Molenberghs/Buyse: The Evaluation of Surrogate Endpoints. Everitt/Rabe-Hesketh: Analyzing Medical Data Using S-PLUS. Evens/Grant: Statistical Methods in Bioinformatics: An Introduction. Gentleman/Carey/Huber/Izirarry/Dudoit: Bioinformatics and Computational Biology Solutions Using R and Bioconductor. Hougaard: Analysis of Multivariate Survival Data. Keyfitz/Caswell: Applied Mathematical Demography 3rd ed. Klein/Moeschberger: Survival Analysis: Techniques for Censored and Truncated Data, 2nd ed. Kleinbaum: Survival Analysis: A Self-Learning Text, 2nd ed. Kleinbaum/Klein: Logistic Regression: A Self-Learning Text, 2nd ed. Lange: Mathematical and Statistical Methods for Genetic Analysis, 2nd ed. Manton/Singer/Suzman: Forecasting the Health of Elderly Populations. Martinussen/Scheike: Dynamic Regression Models for Survival Data. Moyé: Multiple Analyses in Clinical Trials: Fundamentals for Investigators. Nielsen: Statistical Methods in Molecular Evolution. Parmigiani/Garrett/Irizarry/Zeger: The Analysis of Gene Expression Data: Methods and Software. Proschan/Lan/Wittes: Statistical Monitoring of Clinical Trials: A Unified Approach. Salsburg: The Use of Restricted Significance Tests in Clinical Trials. Simon/Korn/McShane/Radmacher/Wright/Zhao: Design and Analysis of DNA Microarray Investigations. Sorensen/Gianola: Likelihood, Bayesian, and MCMC Methods in Quantitative Genetics. Stallard/Manton/Cohen: Forecasting Product Liability Claims: Epidemiology and Modeling in the Manville Asbestos Case. Therneau/Grambsch: Modeling Survival Data: Extending the Cox Model. Ting: Dose Finding in Drug Development. Vittinghoff/Glidden/Shiboski/McCulloch: Regression Methods in Biostatistics: Linear, Logistic, Survival, and Repeated Measures Models. Zhang/Singer: Recursive Partitioning in the Health Sciences.

Michael A. Proschan K.K. Gordan Lan Janet Turk Wittes

Statistical Monitoring of Clinical Trials A Unified Approach

Michael A. Proschan Biostatistics Research Branch, NIAID Bethesda, MD 20892 USA [email protected]

K.K. Gordon Lan Johnson & Johnson Raritan, NJ 08869 [email protected]

Janet Turk Wittes Statistics Collaborative Washington, DC 20036 USA Series Editors M. Gail National Cancer Institute Rockville, MD 20892 USA

K. Krickeberg Le Chatelet F-63270 Manglieu France

A. Tsiatis Department of Statistics North Carolina State University Raleigh, NC 27695 USA

J. Sarnet Department of Epidemiology School of Public Health Johns Hopkins University 615 Wolfe Street Baltimore, MD 21205-2103 USA

W. Wong Department of Statistics Stanford University Stanford, CA 94305-4065 USA

ISBN-13: 978-0-387-30059-7 Library of Congress Control Number: 2005939187 ©2006 Springer Science+Business Media, LLC All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media