Statisical Methods for Dose-Finding Experiments reviews the main statistical approaches for dose-finding in phase I/II clinical trials and presents practical guidance on their correct use.

Features:

• Includes an introductory section, summarizing the essential concepts in dose-finding
• Contains a section on algorithm-based approaches, such as the traditional 3+3 design, and a section on model-based approaches, such as the continual reassessment method
• Explains fundamental issues, such as how to stop trials early and how to cope with delayed or ordinal outcomes
• Discusses in detail the main websites and software used to implement the methods
• Features numerous worked examples making use of real data

Contents

1. Basic concepts in dose-finding
2. Philosophy and methodology of dose-finding – a regulatory perspective (Robert Hemmings).
3. Traditional and modified algorithm-based designs for phase I cancer clinical trials (Weichung Joe Shih and Yong Lin).
4. Accelerated titration designs (Janet Dancey, Boris Freidlin and Larry Rubinstein)
5. Group up-and-down designs in toxicity studies (Anna Ivanova and Nancy Flournoy).
6. The continual reassessment method (Sylvie Chevret and Sarah Zohar).
7. Using Bayesian decision theory in dose-escalation studies (John Whitehead).
8. Dose-escalation with overdose control (Mourad Tighiouart and Andr´e Rogatko).
9. Dose-escalation methods for phase I healthy volunteer studies (Y. Zhou).
10. Defining stopping rules (Sarah Zohar).
11. Dose-finding with delayed binary outcomes in cancer trials (Ying Kuen Cheung).
12. Dose-finding based on multiple ordinal toxicities in phase I oncology trials (B. Nebiyou Bekele and Peter F. Thall).
13. A two-stage design for dose-finding with two agents (Peter F. Thall)
14. Using both efficacy and toxicity for dose-finding (Peter F. Thall and John D. Cook).
15. Websites and software

Index

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