This book not only explains classical statistical analyses of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. The book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.

Inhalt

Preface. Foreword. 1. Hypotheses, Data, Stratification. 2. The analysis of efficacy data of drug trials. 3. The analysis of safety data of drug trials. 4. Equivalence testing. 5. Statistical power and sample size. 6. Interim analysis. 7. Multiple statistical inferences. 8. Principles of linear regression. 9. Subgroup analysis multiple linear regression: confounding, interaction, synergism. 10. Curvilinear regression. 11. Meta-analysis. 12. Crossover studies with continuous variables: power analysis. 13. Crossover studies with binary responses. 14. Post-hoc analysis in clinical trials, a case for logistic regression analysis. 15. quality-of-life assessment in clinical trials. 16. Statistics for the analysis of genetic data. 17. Relationship among statistical distributions. 18. Statistics is not "bloodless" algebra. Appendix. Index.