Statistical thinking for non-statisticians in drug regulation /

• Main Author: Kay, R. (Richard), 1949- (Author)
• Format: eBook
• Language: English
• Published: Chichester, West Sussex, UK ; Hoboken, New Jersey : Wiley Blackwell, 2015.
• Edition: Second edition.
• Subjects: Clinical Trials as Topic > methods.; Drug Approval.; Drug Industry.; Statistics as Topic.; Clinical trials > Statistical methods.; Drugs > Testing > Statistical methods.; Drug approval > Statistical methods.; Pharmaceutical industry > Statistical methods.; MEDICAL > Pharmacology.; Medical.; Electronic books.

Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device ind...

Table of Contents:

• Basic ideas in clinical trial design
• Sampling and inferential statistics
• Confidence intervals and p-values
• Tests for simple treatment comparisons
• Adjusting the analysis
• Regression and analysis of covariance
• Intention-to-treat and analysis sets
• Power and sample size
• Statistical significance and clinical importance
• Multiple testing
• Non-parametric and related methods
• Equivalence and non-inferiority
• The analysis of survival data
• Interim analysis and data monitoring committees
• Bayesian statistics
• Adaptive designs
• Observational studies
• Meta-analysis
• Methods for the safety analysis and safety monitoring
• Diagnosis
• The role of statistics and statisticians.