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Statistical Monitoring of Clinical Trials

A Unified Approach
Buch | Hardcover
268 Seiten
2006 | 1st ed. 2006. Corr. 2nd printing 2007
Springer-Verlag New York Inc.
978-0-387-30059-7 (ISBN)

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Statistical Monitoring of Clinical Trials - Michael A. Proschan, K. K. Gordon Lan, Janet Turk Wittes
CHF 209,70 inkl. MwSt
Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials.Michael Proschan, Gordon Lan, and Janet Wittes are elected Fellows of the American Statistical Association.
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 are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion (“the B-value”) irrespective of the test statistic. The so-called B-value approach to monitoring allows us to use, for different types of trials, the same boundaries and the same simple formula for computing conditional power. Although Brownian motion may sound complicated, the authors make the approach easy by starting with a simple example and building on it, one piece at a time, ultimately showing that Brownian motion works for many different types of clinical trials.


The book will be very valuable to statisticians involved in clinical trials. The main body of the chapters is accessible to anyone with knowledge of a standard mathematical statistics text. More mathematically advanced readers will find rigorous developments in appendices at the end of chapters. Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials.


Michael Proschan, Gordon Lan, and Janet Wittes are elected Fellows of the American Statistical Association. All have spent formative years in the Biostatistics Research Branch of the National Heart, Lung, and Blood Institute (NHLBI/NIH). While there, they were intimately involved in the design and statistical monitoring of large-scale randomized clinical trials, developing methodology to aid in their monitoring. For example, Lan developed, with DeMets, the now widely-used spending function approach to group sequential designs, whose properties were further investigated byProschan. The B-value approach used in the book was introduced in a very influential paper by Lan and Wittes. The statistical theory behind conditional power was developed by Lan, along with Simon and Halperin, and was the cornerstone for the conditional error approach to adaptive clinical trials introduced by Proschan and Hunsberger. All three authors have expertise in adaptive methodology for clinical trials.


Michael Proschan is a Mathematical Statistician at the National Institutes of Health; Gordon Lan is Senior Director of Biometrics at Johnson & Johnson Pharmaceutical Research and Development, L.L.C.; Janet Wittes is President of Statistics Collaborative, a statistical consulting company she founded in 1990.

A General Framework.- Power: Conditional, Unconditional, and Predictive.- Historical Monitoring Boundaries.- Spending Functions.- Practical Survival Monitoring.- Inference Following a Group-Sequential Trial.- Options When Brownian Motion Does Not Hold.- Monitoring for Safety.- Bayesian Monitoring.- Adaptive Sample Size Methods.- Topics Not Covered.- Appendix I: The Logrank and Related Tests.- Appendix II: Group-Sequential Software.

Reihe/Serie Statistics for Biology and Health
Zusatzinfo 32 Illustrations, black and white; XIV, 268 p. 32 illus.
Verlagsort New York, NY
Sprache englisch
Maße 155 x 235 mm
Themenwelt Mathematik / Informatik Mathematik Statistik
Mathematik / Informatik Mathematik Wahrscheinlichkeit / Kombinatorik
Studium Querschnittsbereiche Epidemiologie / Med. Biometrie
ISBN-10 0-387-30059-7 / 0387300597
ISBN-13 978-0-387-30059-7 / 9780387300597
Zustand Neuware
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