Senn S. Statistical Issues in Drug Development

2nd Edition. — Wiley, 2007. — 505 p. — ISBN: 978-0-470-01877-4.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.Four Views of Statistics in Drug Development: Historical, Methodological, Technical and Professional
A Brief and Superficial History of Statistics for Drug
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
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
A Technical appendix
A Technical appendix
Meta-Analysis
Cross-over Trials
n-of-1 Trials
Sequential Trials
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