The objective of a phase II cancer clinical trial is to screen a treatment that can produce a similar or better response rate compared to the current treatment results. This screening is usually carried out in two stages as proposed by Simon. For ineffective treatment, the trial should terminate at
S25.1: Alternative designs for phase II MS trials
✍ Scribed by Karina Eder; Susanne Menzler; Ulrike Held; Martin Daumer; Helmut Küchenhoff; Albrecht Neiß
- Publisher
- John Wiley and Sons
- Year
- 2004
- Tongue
- English
- Weight
- 76 KB
- Volume
- 46
- Category
- Article
- ISSN
- 0323-3847
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In the conduct of a phase II cancer clinical trial, patients usually enter in two stages. If the response rate from the first stage is low, then the study terminates. Within various two-stage designs, Simon proposed the optimal and minimax criteria. In the co-operative group setting, practical consi
Simon's optimal two-stage design is widely used to conduct single-dose phase II clinical trials. We extend this basic methodology to the situation where the researcher desires to test an experimental drug for activity at a low dose level, but is willing to increase the dose part-way through the tria
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