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Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Phase III trials: definition
- Phase III trials are difficult
- Adjuvant chemotherapy for NSCLC
- Chemotherapy / radiation vs. radiation
- Chemotherapy vs. observation
- Statistical aspects of phase III studies: planning
- Eligibility and treatment plan
- Overall survival in total randomized population
- Statistical aspects of phase III trials: execution
- Statistical aspects of phase III trials: analysis
- Why phase III trials? (1)
- Example of phase II vs. phase III study results
- SWOG 0023 study
- S0023: overall survival
- Why phase III trials? (2)
- Bevacizumab - ECOG 4599 trial
- Bevacizumab with chemotherapy: overall survival
- Outcomes for elderly advanced NSCLC
- Economic analysis: all else being equal...
- Quality of life and symptom control
- Cisplatin+pemetrexed vs. cisplatin+gemcitabine
- Overall survival
- Overall survival in non-squamous patients
- Why phase III trials? (3)
- ECOG 4599 trial - advanced NSCLC
- INT SCLC study of daily vs. BID radiotherapy
- The future of phase III trials
- The importance of phase II studies
- Targeted populations
- FLEX: 1st-line stage IIIB/IV NSCLC
- N0723: predictive marker study design
- An opportunity to utilize improved prognosis
- How to use phase III data
- JCOG trial: CDDP/CPT-11 vs. CDDP/VP-16
- Overall survival in the U.S.A
- 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:
Categories:
Therapeutic Areas:
Talk Citation
Edelman, M. (2009, January 6). Phase III trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 10, 2024, from https://doi.org/10.69645/ZDEH9832.Export Citation (RIS)
Publication History
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.