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
A Two-stage Design for Comparing Clinical Trials
β Scribed by Pinyuen Chen; Lifang Hsu
- Publisher
- John Wiley and Sons
- Year
- 1992
- Tongue
- English
- Weight
- 321 KB
- Volume
- 34
- Category
- Article
- ISSN
- 0323-3847
No coin nor oath required. For personal study only.
β¦ Synopsis
Abstract
A twoβstage design is proposed to choose among several experimental treatments and a standard treatment in clinical trials. The first stage employs a selection procedure to select the best treatment, provided it is better than the standard. The second stage tests the hypothesis between the best treatment selected at the first stage (if any) and the standard treatment. All the treatments are assumed to follow normal distributions and the best treatment is the one with the largest population mean. The level and the power are defined and they are used to set up equations to solve unknown first stage sample size, second stage sample size, and procedure parameters. The optimal design is the one that gives the smallest average sample size. Numerical results are presented to illustrate the improvement of one design as compared to existing one stage design.
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