응용통계연구 (The Korean Journal of Applied Statistics)

  • 제25권4호
  • /
  • Pages.575-587
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  • 2012
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  • 1225-066X(pISSN)
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  • 2383-5818(eISSN)
한국통계학회 (The Korean Statistical Society)
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Statistical Methods in Non-Inferiority Trials - A Focus on US FDA Guidelines -

  • 투고 : 2012.04.26
  • 심사 : 2012.06.18
  • 발행 : 2012.08.31
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초록

The effect of a new treatment is proven through the comparison of a new treatment with placebo; however, the number of parent non-inferiority trials tends to grow proportionally to the number of active controls. In a non-inferiority trial a new treatment is approved by proof that the new treatment is not inferior to an active control; however, both additional assumptions and historical trials are needed to show (through the comparison of the new treatment with the active control in a non-inferiority trial) that the new treatment is more efficacious than a putative placebo. The two different methods of using the historical data: frequentist principle method and meta-analytic method. This paper discusses the statistical methods and different Type I error rates obtained through the different methods employed.

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참고문헌

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