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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 Medicine
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Edelman, M. (2009, January 6). Phase III trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved August 25, 2019, from https://hstalks.com/bs/1116/.

Publication History

• Published on January 6, 2009

Financial Disclosures

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