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Printable Handouts
Navigable Slide Index
- Introduction
- Outline
- Background
- Traditional paradigm of drug development
- What is the purpose of a phase II trial?
- Ultimate goals
- Phase II trial designs
- Phase I/III trials: the dangers of skipping phase II
- Traditional single arm phase II trial
- Single arm phase II trial
- Optimal Simon 2 stage design
- Example: "classic" single arm phase II trial
- Bevacizumab + gemcitabine in pancreatic cancer
- Advantages and disadvantages of this trial design
- Endpoints in phase II trial design
- Measurement of response
- Response rate as a primary endpoint (1)
- Response rate as a primary endpoint (2)
- Response rate as a primary endpoint (3)
- Waterfall plot of changes in tumor size
- Response rate is not a perfect endpoint
- Response rate is useful for screening
- Summary: response rate as a primary endpoint
- Modifications of the single arm phase II trial
- Alternative methods to assess response (1)
- Alternative methods to assess response (2)
- Alternative endpoints- time to event
- Alternative endpoints- biological endpoints
- The difficulty in picking an endpoint
- Bayesian statistics (1)
- Bayesian statistics (2)
- Single arm phase II trials
- Randomized phase II trials
- Reference standard-treatment control arm
- Formal comparison between arms
- Randomized phase II: design considerations
- Compare experimental regimens
- Summary: randomized phase II trials
- Phase II/III trials
- Phase II/III trials: statistical analysis
- Phase I/II studies
- Enrichment design: randomized discontinuation (1)
- Enrichment design: randomized discontinuation (2)
- Randomized discontinuation design disadvantages
- Evaluation of randomized discontinuation design
- Limitations of randomized discontinuation design
- Randomized discontinuation design: examples
- Enrichment designs: patients molecular selection
- Problems with molecular selection
- Quality of life in phase II studies
- Correlative studies in phase II
- Correlative studies: caveats
- Incorporating correlatives into phase II trial design
- Summary (1)
- Summary (2)
Topics Covered
- Purpose of phase II trials
- Advantages and disadvantages of common phase II trial designs
- Incorporation of correlative studies
Links
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Talk Citation
Tang, P. (2009, June 16). Emerging trends in phase II trial design [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 5, 2024, from https://doi.org/10.69645/EBPS6929.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Patricia Tang has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.