우월성 임상시험을 위한 통계적 방법론의 이해와 적용
The Statistical Considerations for Superiority Trial
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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.
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.
참고문헌 (6)
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- 이영작, "What is the Clinical Trial?", 한국보건정보통계학회지, 36(1), pp.1~14 (2011), 한국보건정보통계학회
- Armitage P, "Statistical Methods in Medical Research" (2002), Blackwell Science
- Chow SC, "Sample Size Calculations in Clinical Research" (2008), Taylor & Francis, CRC Press
- "Points to consider on 2257 switching between superiority and non-inferiority. 2258" (2000)[URL]
- "Statistical principles for clinical trials (ICH 2337 E-9)", International conference on harmonization (1998), Food and Drug Administration, DHHS