Statistical Issues in Drug Development

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John Wiley & Sons, Feb 28, 2008 - Medical - 524 pages
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Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.

Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. 

This highly readable second edition has been updated to include:

  • Comprehensive coverage of the design and interpretation of clinical trials.
  • Expanded sections on missing data, equivalence, meta-analysis and dose finding.
  • An examination of both Bayesian and frequentist methods.
  • A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics.
  • Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials.

It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

 

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Contents

Acknowledgements
xxi
1 Introduction
1
Part 1 Four Views of Statistics in Drug Development Historical Methodological Technical and Professional
9
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 Pvalues Tests of Hypotheses and Confidence Intervals
43
5 The Work of the Pharmaceutical Statistician
55
Part 2 Statistical Issues Debatable and Controversial Topics in Drug Development
67
14 Multicentre Trials
213
15 Active Control Equivalence Studies
235
16 MetaAnalysis
251
17 Crossover Trials
273
18 nof1 Trials
287
19 Sequential Trials
295
20 Dosefinding
317
21 Concerning Pharmacokinetics and Pharmacodynamics
337

6 Allocating Treatments to Patients in Clinical Trials
69
7 Baselines and Covariate Information
95
8 The Measurement of Treatment Effects
113
9 Demographic Subgroups Representation and Analysis
133
10 Multiplicity
149
11 Intention to Treat Missing Data and Related Matters
165
12 Onesided and Twosided Tests and other Issues to Do with Significance and Pvalues
183
13 Determining the Sample Size
195
22 Bioequivalence Studies
361
23 Safety Data Harms Drug Monitoring and Pharmacoepidemiology
383
24 Pharmacoeconomics and Portfolio Management
405
25 Concerning Pharmacogenetics Pharmacogenomics and Related Matters
433
Glossary
453
Index
483
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About the author (2008)

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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