Statistical Thinking for Non-Statisticians in Drug Regulation focuses on the pharmaceutical non-statistician working within a very strict regulatory environment.

It presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements.

Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.

Statistical Thinking for Non-Statisticians in Drug Regulation:

• Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
• Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
• Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European
• Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

Contents

1. Basic ideas in clinical trial design
2. Sampling and inferential statistics
3. Confidence intervals and p-values
4. Tests for simple treatment comparisons
5. Multi-centre trials
6. Adjusted analyses and analysis of covariance
7. Intention-to-treat and analysis sets
8. Power and sample size
9. Statistical significance and clinical importance
10. Multiple testing
11. Non-parametric and related methods
12. Equivalence and non-inferiority
13. The analysis of survival data
14. Interim analysis and data monitoring committees
15. Meta-analysis
16. The role of statistics and statistician

Index

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