Second edition
by Stephen Senn
Statistical Issues in Drug Development, 2nd edition presents an essential and thought stimulating guide to the statistical issues and controversies involved in drug development.
Features:
- 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
Contents
- Introduction
Part 1: Four Views of Statistics in Drug Development: Historical, Methodological, Technical and Professional
- A Brief and Superficial History of Statistics for Drug Developers
- Design and Interpretation of Clinical Trials as Seen by a Statistician
- Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
- The Work of the Pharmaceutical Statistician
Part 2: Statistical Issues: Debatable and Controversial Topics in Drug Development
- Allocating Treatments to Patients in Clinical Trials
- Baselines and Covariate Information
- The Measurement of Treatment Effects
- Demographic Subgroups: Representation and Analysis
- Multiplicity
- Intention to Treat, Missing Data and Related Matters
- One-sided and Two-sided Tests and Other Issues to Do with Significance and P-values
- Determining the Sample Size
- Multicentre Trials
- Active Control Equivalence Studies
- Meta-Analysis
- Cross-over Trials
- n-of-1 Trials
- Sequential Tr4ials
- Dose-finding
- Concerning Pharmacokinetics and Pharmacodynamics
- Bioequivalence Studies
- Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
- Pharmaco-economics and Portfolio Management
- Concerning Pharmacogenetics, Pharmacogenomics and Related Matters
Index
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