Phase III trials

Edelman, Martin

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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:

Cancer Therapy

Categories:

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 December 7, 2021, from https://hstalks.com/bs/1116/.