Statistical Issues in Drug Development / Edition 2

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This book for non-statisticians explains the statistical issues in drug development to help them plan, analyze and interpret clinical trials. It also examines the commercial pressures, regulatory standards and high scrutiny that accompany this field.

A brief history of statistics for drug developers, design & interpretation of clinical trials as seen by a statistician.

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Editorial Reviews

From the Publisher

For all his contributions to the development and exposition of medical statistics Stephen Senn is awarded the 2009 Bradford Hill Medal by the Royal Statistical Society.

• This book is a thought provoking, intriguing, and often challenging read. The author is unafraid to tackle weighty philosophical and paradigmatic issues, and he generally does so with great skill and insight. ...this excellent book should serve to inspire both statisticians and life scientists.? (Journal of the American Statistical Association, September 2009)

"For statisticians, this should be required reading for anyone considering or starting out on a career in clinical drug development. I am also quite sure that most experienced statisticians would find this a useful book to dip into on occasion ... . This book will not disappoint." (Journal of the Royal Statistical Society: Series A (Statistics in Society), April 2009)

"This book is an outstanding effort from a statistician of heroic proportions. Someone like me is only capable of sitting on the curb and applauding wildly." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)

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Product Details

  • ISBN-13: 9780470018774
  • Publisher: Wiley
  • Publication date: 1/28/2008
  • Series: Statistics in Practice Series
  • Edition description: New Edition
  • Edition number: 2
  • Pages: 524
  • Product dimensions: 6.81 (w) x 9.67 (h) x 1.32 (d)

Meet the Author

Stephen Senn has worked for the NHS in England, as a lecturer in Scotland and in drug development in Switzerland (with CIBA-Geigy). Until recently he was Professor of Pharmaceutical and Health Statistics at University College London but since September 2003 he has been  Professor of Statistics at Glasgow University. His books, Cross-over Trials in Clinical Research (1993, 2nd edition 2002) and Statistical Issues in Drug Development (1997) are published by Wiley and his latest book, Dicing with Death (2003) by Cambridge University Press. In 2001, he was the first recipient of the George C Challis award for biostatistics of the University of Florida. He is a member of the editorial boards of Statistics in Medicine, Statistical Methods in Medical Research, Pharmaceutical Statistics and Applied Clinical Trials and is a section editor for the Wiley Statistics in Practice series.

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Table of Contents

Series Preface
1 Introduction 1
2 A Brief and Superficial History of Statistics for Drug Developers 11
3 Design and Interpretation of Clinical Trials as Seen by a Statistician 27
4 Probability, Bayes, P-Values, Test of Hypotheses and Confidence Intervals 43
5 The Work of the Pharmaceutical Statistician 55
6 Allocating Treatments to Patients in Clinical Trials 69
7 Baselines and Covariate Information 95
8 The Measurement of Treatment Effects 111
9 Demographic Sub-groups: Representation and Analysis 127
10 Multiplicity 141
11 Intention to Treat 153
12 One-sided and Two-sided Tests 161
13 Determining the Sample Size 169
14 Multi-Centre Trials 187
15 Active Control Equivalence Studies 207
16 Meta-Analysis 219
17 Cross-over Trials 237
18 N-of-1 Trials 249
19 Sequential Trials 257
20 Dose-Finding 275
21 Concerning Pharmacokinetics and Pharmacodynamics 291
22 Bioequivalence Studies 315
23 Safety Data, Drug Monitoring and Pharmaco-epidemiology 333
24 Pharmaco-economics and Portfolio Management 353
Glossary 377
Index 407
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