Short description Concern over the safety and efficacy of drug therapy is a significant issue worldwide. Clinical trials are scientific investigations that examine and evaluate the safety and efficacy of drug therapy. Balancing statistical and clinical aspects with a focus on interactions among clinical scientists, this important resource covers issues that may arise during the various phases throughout pharmaceutical research and development. The Second Edition takes into consideration the rapid development in design and analysis in clinical research over the past five years, including, but not limited to, the many changes in technology and the regulatory environment.
From the contents Preface.
Preface to the First Edition.
1. Introduction.
2. Basic Statistical Concepts.
3. Basic Design Considerations.
4. Randomization and Blinding.
5. Designs for Clinical Trials.
6. Designs for Cancer Clinical Trials.
7. Classification of Clinical Trials.
8. Analysis of Continuous Data.
9. Analysis of Categorical Data.
10. Censored Data and Interim Analysis.
11. Sample Size Determination.
12. Issues in Efficacy Evaluation.
13. Safety Assessment.
14. Preparation and Implementation of a Clinical Protocol.
