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Statistical Issues in Drug Development 2nd edition [Hardback]

4.12/5 (9 ratings by Goodreads)
(University of Glasgow)
  • Formāts: Hardback, 524 pages, height x width x depth: 246x173x34 mm, weight: 1011 g
  • Sērija : Statistics in Practice
  • Izdošanas datums: 04-Jan-2008
  • Izdevniecība: Wiley-Interscience
  • ISBN-10: 0470018771
  • ISBN-13: 9780470018774
Citas grāmatas par šo tēmu:
Statistical Issues in Drug Development 2nd editionPalielināt
  • Formāts: Hardback, 524 pages, height x width x depth: 246x173x34 mm, weight: 1011 g
  • Sērija : Statistics in Practice
  • Izdošanas datums: 04-Jan-2008
  • Izdevniecība: Wiley-Interscience
  • ISBN-10: 0470018771
  • ISBN-13: 9780470018774
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780470018774.html
Keywords:
Senn (statistics, U. of Glasgow, UK) discusses the statistical issues related to drug development, presenting them in a way that life scientists working in the field can understand. First covering historical, philosophical, technical, and professional perspectives, he then outlines single issues. This edition has expanded sections on missing data, equivalence, meta-analysis, baselines, measuring effects, intention to treat, sequential analysis, and dose finding. A new chapter on pharmacogenomics has been added, as well as more on pharmaco-epidemiology and pharmaco-economics. It is aimed at statisticians and non-statisticians working in the pharmaceutical industry, undergraduate and graduate students, regulatory bodies, and medical research institutes. Other updates include extensive references to guidelines of the International Conference of Harmonization issued since the first edition, especially ICH E9, Statistical Principles for Clinical Trials. Annotation ©2008 Book News, Inc., Portland, OR (booknews.com)

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.

Recenzijas

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)

Preface to the Second Edition xiii
Preface to the First Edition xvii
Acknowledgements xxi
Introduction
1(8)
Drug development
1(1)
The role of statistics in drug development
2(1)
The object of this book
3(1)
The author's knowledge of statistics in drug development
4(1)
The reader and his or her knowledge of statistics
4(1)
How to use the book
5(4)
References
6(3)
Part 1 Four Views of Statistics in Drug Development: Historical, Methodological, Technical and Professional
9(58)
A Brief and Superficial History of Statistics for Drug Developers
11(16)
Introduction
11(1)
Early Probabilists
12(1)
James Bernoulli (1654--1705)
13(1)
John Arbuthnott (1667--1753)
14(1)
The mathematics of probability in the late 17th, the 18th and early 19th centuries
14(1)
Thomas Bayes (1701--1761)
15(1)
Adolphe Quetelet (1796--1874)
16(1)
Francis Galton (1822--1911)
16(1)
Karl Pearson (1857--1936)
17(1)
`Student' (1876--1937)
17(1)
R.A. Fisher (1890--1962)
17(1)
Modern mathematical statistics
18(1)
Medical statistics
19(1)
Statistics in clinical trials today
20(1)
The current debate
21(1)
A living science
21(2)
Further reading
23(4)
References
23(4)
Design and Interpretation of Clinical Trials as Seen by a Statistician
27(16)
Prefatory warning
27(1)
Introduction
27(1)
Defining effects
28(1)
Practical problems in using the counterfactual argument
28(1)
Regression to the mean
29(4)
Control in clinical trials
33(1)
Randomization
34(2)
Blinding
36(1)
Using concomitant observations
37(1)
Measuring treatment effects
38(1)
Data generation models
39(2)
In conclusion
41(1)
Further reading
41(2)
References
41(2)
Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
43(12)
Introduction
43(1)
An example
44(1)
Odds and sods
44(1)
The Bayesian solution to the example
45(1)
Why don't we regularly use the Bayesian approach in clinical trials?
46(1)
A frequentist approach
47(1)
Hypothesis testing in controlled clinical trials
48(1)
Significance tests and P-values
49(1)
Confidence intervals and limits and credible intervals
50(1)
Some Bayesian criticism of the frequentist approach
51(1)
Decision theory
51(1)
Conclusion
52(1)
Further reading
52(3)
References
53(2)
The Work of the Pharmaceutical Statistician
55(12)
Prefatory remarks
55(1)
Introduction
56(1)
In the beginning
57(1)
The trial protocol
57(1)
The statistician's role in planning the protocol
58(1)
Sample size determination
59(1)
Other important design issues
60(1)
Randomization
60(1)
Data collection preview
61(1)
Performing the trial
61(1)
Data analysis preview
61(1)
Analysis and reporting
62(1)
Other activities
63(1)
Statistical research
63(1)
Further reading
64(3)
References
65(2)
Part 2 Statistical Issues: Debatable and Controversial Topics in Drug Development
67(386)
Allocating Treatments to Patients in Clinical Trials
69(26)
Background
69(2)
Issues
71(17)
References
87(1)
Technical appendix
88(7)
Baselines and Covariate Information
95(18)
Background
95(3)
Issues
98(11)
References
108(1)
Technical appendix
109(4)
The Measurement of Treatment Effects
113(20)
Background
113(1)
Issues
114(16)
References
129(1)
Technical appendix
130(3)
Demographic Subgroups: Representation and Analysis
133(16)
Background
133(1)
Issues
134(11)
References
144(1)
Technical appendix
145(4)
Multiplicity
149(16)
Background
149(1)
Issues
150(12)
References
161(1)
Technical appendix
162(3)
Intention to Treat, Missing Data and Related Matters
165(18)
Background
165(2)
Issues
167(13)
References
178(2)
Technical appendix
180(3)
One-sided and Two-sided Tests and other Issues to Do with Significance and P-values
183(12)
Background
183(1)
Issues
184(11)
References
192(3)
Determining the Sample Size
195(18)
Background
195(3)
Issues
198(15)
References
211(2)
Multicentre Trials
213(22)
Background
213(1)
Issues
213(18)
References
230(1)
Technical appendix
231(4)
Active Control Equivalence Studies
235(16)
Background
235(2)
Issues
237(12)
References
247(2)
Technical appendix
249(2)
Meta-Analysis
251(22)
Background
251(2)
Issues
253(17)
References
268(2)
Technical appendix
270(3)
Cross-over Trials
273(14)
Background
273(2)
Issues
275(12)
References
284(3)
n-of-1 Trials
287(8)
Background
287(2)
Issues
289(6)
References
293(2)
Sequential Trials
295(22)
Background
295(7)
Issues
302(15)
References
313(4)
Dose-finding
317(20)
Background
317(2)
Issues
319(18)
References
334(3)
Concerning Pharmacokinetics and Pharmacodynamics
337(24)
Background
337(6)
Issues
343(18)
References
358(3)
Bioequivalence Studies
361(22)
Background
361(1)
Issues
362(21)
References
379(4)
Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
383(22)
Background
383(5)
Issues
388(17)
References
403(2)
Pharmaco-economics and Portfolio Management
405(28)
Background
405(2)
Issues
407(26)
References
429(4)
Concerning Pharmacogenetics, Pharmacogenomics and Related Matters
433(20)
Background
433(4)
Issues
437(14)
References
450(1)
Technical appendix
451(2)
Glossary 453(30)
Index 483


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.