Introduction to Statistics in Pharmaceutical Clinical Trials

Abstract

1. The discipline of statistics: introduction and terminology -- 2. The role of clinical trials in new drug development -- 3. Research questions and research hypotheses -- 4. Study design and experimental methodology -- 5. Data, central tendency and variation -- 6. Probability, hypothesis testing and estimation -- 7. Early phase clinical trials -- 8. Confirmatory clinical trials: safety data 1 -- 9. Confirmatory clinical trials: safety data II -- 10. Confirmatory clinical trials: analysis of categorical efficacy data -- 11. Confirmatory clinical trials: analysis of continuous efficacy data -- 12. Additional statistical considerations in clinical trials -- 13. Concluding remarks -- Appendices.