Quantitative Decisions in Drug Development

1. Clinical Testing of a New Drug
Christy Chuang-Stein, Simon Kirby

2. A Frequentist Decision-Making Framework
Christy Chuang-Stein, Simon Kirby

3. Characteristics of a Diagnostic Test
Christy Chuang-Stein, Simon Kirby

4. The Parallel Between Clinical Trials and Diagnostic Tests
Christy Chuang-Stein, Simon Kirby

5. Incorporating Information from Completed Trials in Future Trial Planning
Christy Chuang-Stein, Simon Kirby

6. Choosing Metrics Appropriate for Different Stages of Drug Development
Christy Chuang-Stein, Simon Kirby

7. Designing Proof-of-Concept Trials with Desired Characteristics
Christy Chuang-Stein, Simon Kirby

8. Designing Dose-Response Studies with Desired Characteristics
Christy Chuang-Stein, Simon Kirby

9. Designing Confirmatory Trials with Desired Characteristics
Christy Chuang-Stein, Simon Kirby

10. Designing Phase 4 Trials
Christy Chuang-Stein, Simon Kirby

11. Other Metrics that Have Been Proposed to Optimize Drug Development Decisions
Christy Chuang-Stein, Simon Kirby

12. Discounting Prior Results to Account for Selection Bias
Christy Chuang-Stein, Simon Kirby

13. Additional Topics
Christy Chuang-Stein, Simon Kirby

Keywords: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Biostatistics, Drug Safety and Pharmacovigilance, Pharmaceutical Sciences/Technology, Quality Control, Reliability, Safety and Risk