Pharmaceutical Clinical Trials

ntroduction to Statistics in Pharmaceutical Clinical Trials
First edition

Todd A Durham - Senior Director, Biostatistics and Data Management and J Rick Turner - Associate Professor of Clinical Research

All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics.

Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.

This textbook conveys:

* why, and how data are collected in clinical studies
* how these data are summarized and analyzed
* what the results mean in the context of the clinical research question
* how the results are communicated to regulatory agencies and to the scientific and medical communities.



Designed primarily for students of pharmacy, clinical research, and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.

Contents:
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 I: 9. Confirmatory Clinical Trials: Safety Data II: 10. Confirmatory Trials: Analysis of Categorical Efficacy Data: 11. Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data: 12. Additional Statistical Considerations in Clinical Trials: 13. Concluding Comments: Appendix: References: : : : : : : : :