Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Overview
3. Phase III trials: definition
4. Phase III trials are difficult
5. Adjuvant chemotherapy for NSCLC
6. Chemotherapy / radiation vs. radiation
7. Chemotherapy vs. observation
8. Statistical aspects of phase III studies: planning
9. Eligibility and treatment plan
10. Overall survival in total randomized population
11. Statistical aspects of phase III trials: execution
12. Statistical aspects of phase III trials: analysis
13. Why phase III trials? (1)
14. Example of phase II vs. phase III study results
15. SWOG 0023 study
16. S0023: overall survival
17. Why phase III trials? (2)
18. Bevacizumab - ECOG 4599 trial
19. Bevacizumab with chemotherapy: overall survival
20. Outcomes for elderly advanced NSCLC
21. Economic analysis: all else being equal...
22. Quality of life and symptom control
23. Cisplatin+pemetrexed vs. cisplatin+gemcitabine
24. Overall survival
25. Overall survival in non-squamous patients
26. Why phase III trials? (3)
27. ECOG 4599 trial - advanced NSCLC
28. INT SCLC study of daily vs. BID radiotherapy
29. The future of phase III trials
30. The importance of phase II studies
31. Targeted populations
32. FLEX: 1st-line stage IIIB/IV NSCLC
33. N0723: predictive marker study design
34. An opportunity to utilize improved prognosis
35. How to use phase III data
36. JCOG trial: CDDP/CPT-11 vs. CDDP/VP-16
37. Overall survival in the U.S.A
38. Summary and conclusions

Topics Covered

• Phase III trials: definition and difficulties
• Statistical aspects: planning, execution and analysis
• Why phase III trials?
• Phase II results are not always correct
• Unsuspected risks and benefits may be revealed
• Economic analysis
• The future of phase III trials
• Targeted therapies and targeted populations
• How to use phase III results

Links

Series:

• Cancer Therapy

Categories:

• Cancer
• Clinical Practice
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Publication History

• Published on January 6, 2009
• Archived on February 25, 2021

Financial Disclosures

• Dr. Edelman serves on Data Safety and Monitoring Boards for Astra Zeneca, Takeda, GSK and Seattle Genetics. He currently or has recently received research funding (to his institution) from Amgen, Regeneron, GSK. He has received compensation as a consultant for Flame, Kanaph, Regeneron, Windmil, and Proventus.