A Practical Guide To Designing Phase II Trials In Oncology (Statistics Practice) Sarah R. Brown, Walter M. Gregory, Christopher J. Twelves, Julia B
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- A Practical Guide to Designing Phase II Trials in Oncology
- 1 Introduction
- 2 Key points for consideration
- 3 Designs for single experimental therapies with a single arm
- 4 Designs for single experimental therapies including randomisation
- 5 Treatment selection designs
- 5.1 Including a control arm
- 5.1.1 One-stage designs
- 5.1.2 Two-stage designs
- 5.1.3 Multi-stage designs
- 5.1.4 Continuous monitoring designs
- 5.1.5 Decision-theoretic designs
- 5.1.6 Three-outcome designs
- 5.1.7 Phase II/III designs – same primary outcome measure at phase II and phase III
- 5.1.8 Phase II/III designs – different primary outcome measures at phase II and phase III
- 5.1.9 Randomised discontinuation designs
- 5.2 Not including a control arm
- 5.1 Including a control arm
- 6 Designs incorporating toxicity as a primary outcome
- 7 Designs evaluating targeted subgroups
- 8 ‘Chemo-radio-sensitisation’ in head and neck cancer
- 9 Combination chemotherapy in second-line treatment of non-small cell lung cancer
- 10 Selection by biomarker in prostate cancer
- 11 Dose selection in advanced multiple myeloma
- 12 Targeted therapy for advanced colorectal cancer
- 13 Phase II oncology trials: Perspective from industry
- References
- Index
- Statistics in Practice