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1. Introduction
2. Dose-finding in oncology
3. Dose lmiting toxicity (DLT)
4. The maximum tolerable dose (MTD)
5. Dose-toxicity relationship
6. Starting dose and dose level selection
7. Traditional or 3+3 design (1)
8. Traditional or 3+3 design (2)
9. Operating characteristics of 3+3 design
10. Advantages and disadvantages of the 3+3 design
11. A+B designs
12. A+B designs: definition
13. A+B designs: how to construct
14. A+B designs: examples
15. Trials with the MTD defined using toxicity grades
16. Defining MTD using toxicity grades: example (1)
17. Defining MTD using toxicity grades: example (2)
18. Defining MTD using toxicity grades: example (3)
19. A summary
20. Escalation vs. fixed sample size designs for trials
21. Fixed sample size vs. A+B designs: which to use?
22. Fixed sample size designs
23. Continual reassessment method (CRM)
24. Cumulative cohort design (CCD) to find the MTD
25. Components of the CRM and CCD
26. Start-up rule (1)
27. Start-up rule (2)
28. Estimation of MTD after cumulative cohort design
29. Design modifications for delayed toxicity outcomes
30. Oncology trial with delayed toxicity outcomes (1)
31. Oncology trial with delayed toxicity outcomes (2)
32. Oncology trial with delayed toxicity outcomes (3)
33. An example of a phase I trial with two agents
34. An example of a phase I trial with ordered groups
35. Single vs. separate trials
36. Bayesian designs for 2 agents/ordered groups trial
37. Isotonic designs for 2 agents/ordered group trials
38. References (1)
39. References (2)
40. References (3)
41. Additional reading

Topics Covered

• Maximum tolerable dose
• Standard or 3+3 design
• A+B designs
• Phase I trials that use toxicity grades
• Escalation versus fixed sample size designs for dose-finding trials
• Continual reassessment method
• Cumulative cohort design
• Start-up rule
• Design modifications for delayed toxicity outcomes
• Trials with two agents and ordered groups

Links

Series:

• Design and Analysis of Randomized Clinical Trials

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on October 1, 2007
• Archived on May 31, 2018

Financial Disclosures

• Prof. Anastasia Ivanova has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.