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J Health Info Stat 2011;36(2):200-205.
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| 우월성 임상시험을 위한 통계적 방법론의 이해와 적용 |
| 임지연 , 곽민정 |
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| The Statistical Considerations for Superiority Trial |
| Chi Yeon Lim , Min Jung Kwak |
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| ABSTRACT |
Objectives:
We review the statistical considerations for superiority trial to design appropriate statistical hypothesis and decision-making.
Methods:
We plan superiority design especially for placebo-controlled trial or combination drug trial. Many previous studies employed two-sided hypothesis testing and misuse of significance level, and this resulted in wrong sample size and confidence interval. Therefore we compared sample size estimation and confidence interval according to one-sided and two-sided hypotheses,
Results:
There are differences in sample size estimation and confidence interval according to one-sided or two-sided hypotheses with the pre-determined power at the significance level,
Conclusions:
For superiority trial in the confirmatory stage, one-sided hypothesis is advisable, We can estimate a sample size from this hypothesis and recommend to use a confidence interval for decision-making. |
| Key words:
Sample size, Superiority trial, Confidence intervals |
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