Statistical Issues in Drug Development, Second Edition

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.Content:
Chapter 1 Introduction (pages 1–7):
Chapter 2 A Brief and Superficial History of Statistics for Drug Developers (pages 9–25):
Chapter 3 Design and Interpretation of Clinical Trials as Seen by a Statistician (pages 27–42):
Chapter 4 Probability, Bayes, P?Values, Tests of Hypotheses and Confidence Intervals (pages 43–53):
Chapter 5 The Work of the Pharmaceutical Statistician (pages 55–66):
Chapter 6 Allocating Treatments to Patients in Clinical Trials (pages 67–93):
Chapter 7 Baselines and Covariate Information (pages 95–112):
Chapter 8 The Measurement of Treatment Effects (pages 113–131):
Chapter 9 Demographic Subgroups: Representation and Analysis (pages 133–148):
Chapter 10 Multiplicity (pages 149–164):
Chapter 11 Intention to Treat, Missing Data and Related Matters (pages 165–181):
Chapter 12 One?Sided and Two?Sided Tests and other Issues to Do with Significance and P?Values (pages 183–193):
Chapter 13 Determining the Sample Size (pages 195–212):
Chapter 14 Multicentre Trials (pages 213–233):
Chapter 15 Active Control Equivalence Studies (pages 235–250):
Chapter 16 Meta?Analysis (pages 251–272):
Chapter 17 Cross?over Trials (pages 273–285):
Chapter 18 n?of?1 Trials (pages 287–294):
Chapter 19 Sequential Trials (pages 295–315):
Chapter 20 Dose?Finding (pages 317–336):
Chapter 21 Concerning Pharmacokinetics and Pharmacodynamics (pages 337–360):
Chapter 22 Bioequivalence Studies (pages 361–381):
Chapter 23 Safety Data, Harms, Drug Monitoring and Pharmaco?Epidemiology (pages 383–404):
Chapter 24 Pharmaco?Economics and Portfolio Management (pages 405–431):
Chapter 25 Concerning Pharmacogenetics, Pharmacogenomics and Related Matters (pages 433–452):