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1. Introduction
2. Outline
3. Background
4. Traditional paradigm of drug development
5. What is the purpose of a phase II trial?
6. Ultimate goals
7. Phase II trial designs
8. Phase I/III trials: the dangers of skipping phase II
9. Traditional single arm phase II trial
10. Single arm phase II trial
11. Optimal Simon 2 stage design
12. Example: "classic" single arm phase II trial
13. Bevacizumab + gemcitabine in pancreatic cancer
14. Advantages and disadvantages of this trial design
15. Endpoints in phase II trial design
16. Measurement of response
17. Response rate as a primary endpoint (1)
18. Response rate as a primary endpoint (2)
19. Response rate as a primary endpoint (3)
20. Waterfall plot of changes in tumor size
21. Response rate is not a perfect endpoint
22. Response rate is useful for screening
23. Summary: response rate as a primary endpoint
24. Modifications of the single arm phase II trial
25. Alternative methods to assess response (1)
26. Alternative methods to assess response (2)
27. Alternative endpoints- time to event
28. Alternative endpoints- biological endpoints
29. The difficulty in picking an endpoint
30. Bayesian statistics (1)
31. Bayesian statistics (2)
32. Single arm phase II trials
33. Randomized phase II trials
34. Reference standard-treatment control arm
35. Formal comparison between arms
36. Randomized phase II: design considerations
37. Compare experimental regimens
38. Summary: randomized phase II trials
39. Phase II/III trials
40. Phase II/III trials: statistical analysis
41. Phase I/II studies
42. Enrichment design: randomized discontinuation (1)
43. Enrichment design: randomized discontinuation (2)
44. Randomized discontinuation design disadvantages
45. Evaluation of randomized discontinuation design
46. Limitations of randomized discontinuation design
47. Randomized discontinuation design: examples
48. Enrichment designs: patients molecular selection
49. Problems with molecular selection
50. Quality of life in phase II studies
51. Correlative studies in phase II
52. Correlative studies: caveats
53. Incorporating correlatives into phase II trial design
54. Summary (1)
55. Summary (2)

Topics Covered

• Purpose of phase II trials
• Advantages and disadvantages of common phase II trial designs
• Incorporation of correlative studies

Links

Series:

• Cancer Therapy

Categories:

• Cancer
• Clinical Practice
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Publication History

• Published on June 16, 2009
• Archived on June 29, 2021

Financial Disclosures

• Dr. Patricia Tang has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.