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E-raamat: Statistical Issues in Drug Development

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(University College, London)
  • Formaat: PDF+DRM
  • Sari: Statistics in Practice
  • Ilmumisaeg: 21-May-2021
  • Kirjastus: John Wiley & Sons Inc
  • Keel: eng
  • ISBN-13: 9781119238607
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Statistical Issues in Drug DevelopmentSuurem pilt
  • Formaat: PDF+DRM
  • Sari: Statistics in Practice
  • Ilmumisaeg: 21-May-2021
  • Kirjastus: John Wiley & Sons Inc
  • Keel: eng
  • ISBN-13: 9781119238607
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"This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard. This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development. The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums"--

This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard.

This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development.  The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums.

Preface to the Third Edition xi
Preface to the Second Edition xv
Preface to the First Edition xix
Acknowledgements xxiii
1 Introduction
1(8)
1.1 Drug Development
1(1)
1.2 The Role of Statistics in Drug Development
2(1)
1.3 The Object of this Book
3(1)
1.4 The Author's Knowledge of Statistics in Drug Development
4(1)
1.5 The Reader and Her or His Knowledge of Statistics
5(1)
1.6 How to Use the Book
6(3)
Part 1 Four Views of Statistics in Drug Development: Historical, Methodological, Technical and Professional 9(66)
2 A Brief and Superficial History of Statistics for Drug Developers
11(20)
2.1 Introduction
11(1)
2.2 Early Probabilists
12(1)
2.3 James Bernoulli (1654-1705)
13(1)
2.4 John Arbuthnott (1667-1753)
14(2)
2.5 The Mathematics of Probability in the Late Seventeenth, the Eighteenth, and Early Nineteenth Centuries
16(1)
2.6 Thomas Bayes (1701-1761)
17(1)
2.7 Adolphe Quetelet (1796-1874)
18(1)
2.8 George Biddell Airy (1801-1892)
18(1)
2.9 Francis Galton (1822-1911)
18(1)
2.10 Karl Pearson (1857-1936)
19(1)
2.11 'Student' (1876-1937)
19(1)
2.12 R.A. Fisher (1890-1962)
19(1)
2.13 Modern Mathematical Statistics
20(1)
2.14 Medical Statistics
21(1)
2.15 Statistics in Clinical Trials Today
22(1)
2.16 The Current Debate
23(1)
2.17 A Living Science
24(1)
2.18 Further Reading
25(6)
3 Design and Interpretation of Clinical Trials as Seen by a Statistician
31(18)
3.1 Prefatory Warning
31(1)
3.2 Introduction
31(1)
3.3 Defining Effects
32(1)
3.4 Practical Problems in Using the Counterfactual Argument
32(1)
3.5 Regression to the Mean
33(4)
3.6 Control in Clinical Trials
37(1)
3.7 Randomization
38(2)
3.8 Blinding
40(2)
3.9 Using Concomitant Observations
42(1)
3.10 Measuring Treatment Effects
43(1)
3.11 Data Generation Models
44(1)
3.12 In Conclusion
45(1)
3.13 Further Reading
45(4)
4 Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
49(12)
4.1 Introduction
49(1)
4.2 An Example
50(1)
4.3 Odds and Sods
50(1)
4.4 The Bayesian Solution to the Example
51(1)
4.5 Why Don't We Regularly Use the Bayesian Approach in Clinical Trials?
52(1)
4.6 A Frequentist Approach
53(1)
4.7 Hypothesis Testing in Controlled Clinical Trials
54(1)
4.8 Significance Tests and P-values
55(1)
4.9 Confidence Intervals and Limits and Credible Intervals
56(1)
4.10 Some Bayesian Criticism of the Frequentist Approach
57(1)
4.11 Decision Theory
57(1)
4.12 Conclusion
58(1)
4.13 Further Reading
58(3)
5 The Work of the Pharmaceutical Statistician
61(14)
5.1 Prefatory Remarks
61(1)
5.2 Introduction
62(1)
5.3 In the Beginning
63(1)
5.4 The Trial Protocol
63(1)
5.5 The Statistician's Role in Planning the Protocol
64(1)
5.6 Sample Size Determination
65(1)
5.7 Other Important Design Issues
66(1)
5.8 Randomization
66(1)
5.9 Data Collection Preview
67(1)
5.10 Performing the Trial
67(1)
5.11 Data Analysis Preview
67(1)
5.12 Analysis and Reporting
68(1)
5.13 Other Activities
69(1)
5.14 Statistical Research
69(1)
5.15 Further Reading
70(5)
Part 2 Statistical Issues: Debatable and Controversial Topics in Drug Development 75(496)
6 Allocating Treatments to Patients in Clinical Trials
77(32)
6.1 Background
77(2)
6.2 Issues
79(25)
6.A Technical Appendix
104(5)
7 Baselines and Covariate Information
109(24)
7.1 Background
109(3)
7.2 Issues
112(17)
7.A Technical Appendix
129(4)
8 The Measurement of Treatment Effects
133(26)
8.1 Background
133(1)
8.2 Issues
134(22)
8.A Technical Appendix
156(3)
9 Demographic Subgroups: Representation and Analysis
159(22)
9.1 Background
159(2)
9.2 Issues
161(15)
9.A Technical Appendix
176(5)
10 Multiplicity
181(22)
10.1 Background
181(1)
10.2 Issues
182(18)
10.A Technical Appendix
200(3)
11 Intention-to-Treat, Missing Data and Related Matters
203(22)
11.1 Background
203(2)
11.2 Issues
205(17)
11.A Technical Appendix
222(3)
12 One-Sided and Two-Sided Tests and Other Issues to Do with Significance and P-values
225(16)
12.1 Background
225(1)
12.2 Issues
226(15)
13 Determining the Sample Size
241(24)
13.1 Background
241(3)
13.2 Issues
244(21)
14 Multicentre Trials
265(24)
14.1 Background
265(1)
14.2 Issues
266(19)
14.A Technical Appendix
285(4)
15 Active Control Equivalence Studies
289(18)
15.1 Background
289(2)
15.2 Issues
291(13)
15.A Technical Appendix
304(3)
16 Meta-Analysis
307(32)
16.1 Background
307(2)
16.2 Issues
309(26)
16.A Technical Appendix
335(4)
17 Cross-Over Trials
339(16)
17.1 Background
339(2)
17.2 Issues
341(14)
18 n-of-1 Dials
355(12)
18.1 Background
355(2)
18.2 Issues
357(10)
19 Sequential and Flexible Trials
367(26)
19.1 Background
367(8)
19.2 Issues
375(18)
20 Dose-Finding
393(26)
20.1 Background
393(2)
20.2 Issues
395(24)
21 Concerning Pharmacokinetics and Pharmacodynamics
419(28)
21.1 Background
419(7)
21.2 Issues
426(21)
22 Bioequivalence Studies
447(26)
22.1 Background
447(2)
22.2 Issues
449(24)
23 Safety Data, Harms, Drug Monitoring and Pharmaco-Epidemiology
473(34)
23.1 Background
473(7)
23.2 Issues
480(27)
24 Pharmaco-economics and Portfolio Management
507(34)
24.1 Background
507(2)
24.2 Issues
509(32)
25 Concerning Pharmacogenetics, Pharmacogenomics and Personalized Medicine
541(30)
25.1 Background
541(6)
25.2 Issues
547(22)
25.A Technical Appendix
569(2)
Glossary 571(32)
Index 603
Professor Stephen Senn (MSc, PhD, CStat) is a statistical consultant, researcher and blogger. He has extensive experience in both academia and industry, and is recognized worldwide for his studies in statistical methodology applied to drug development.

Professor Senn has been the recipient of national and international awards, including the 1st George C Challis award for Biostatistics at the University of Florida, and the Bradford Hill Medal of the Royal Statistical Society. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics (ISCB) and has honorary professorships in statistics at The University of Sheffield and the University of Edinburgh.
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