Phase II Clinical Development of New Drugs

1. Introduction
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

2. Concept of Alpha
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

3. Confirmation and Exploration
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

4. Design a Proof of Concept Trial
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

5. Design of Dose-Ranging Trials
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

6. Combining Proof of Concept and Dose-Ranging Trials
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

7. Risks of Inconclusiveness
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

8. Analysis of a Proof of Concept Study
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

9. Data Analysis for Dose-Ranging Trials with Continuous Outcome
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

10. Data Analysis of Dose-Ranging Trials for Binary Outcomes
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

11. Bayesian Approach
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

12. Overview of Phase III Clinical Trials
Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

Keywords: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Pharmaceutical Sciences/Technology, Management