Exploratory study on interim analyses for breast cancer trials
碩士 === 國立陽明大學 === 公共衛生研究所 === 96 === It is generally agreed that a clinical trial should be stopped early based on the ethical and economic considerations if one treatment group has either superior efficacy or severe side effects. The timing of stopping is determined by group sequential design and a...
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| Format: | Others |
| Language: | zh-TW |
| Published: |
2008
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| Online Access: | http://ndltd.ncl.edu.tw/handle/74444142433120287403 |
| Summary: | 碩士 === 國立陽明大學 === 公共衛生研究所 === 96 === It is generally agreed that a clinical trial should be stopped early based on the ethical and economic considerations if one treatment group has either superior efficacy or severe side effects. The timing of stopping is determined by group sequential design and assessed according to the result of the interim analyses. However, there is no formal guidance on breast cancer trials to describe the way for designing the interim analyses for sponsors.
The issues of this research include the choice of the stopping rule, the numbers of the interim analyses while designing the clinical protocol for the phase III breast cancer trials according to the disease properties of breast cancer. We conduct the case studies of the published breast cancer trials which designed by interim analyses and investigate the studies with different stopping rules. We expect to provide the guidance for the application of interim analysis in breast cancer trial.
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