1992 年 13 巻 2 号 p. 39-45
In phase III comparative clinical trials for a new drug application in Japan, a test drug is accepted if the efficacy and/or usefulness of the test drug shows equal or more than equal to that of the control drug (not a placebo). Hence, the needs of statistical tests for testing equivalence, or more than equivalence is increasing. Therefore, we established the following two null hypotheses for testing equivalence, or more than equivalence which adjust for prognostic factors by stratification.
1) Pi11 = ƒPi01 i=1,2,..,L (0<ƒ<1,ƒis a given constant)
2) (Pi11 (1—Pi01)) / ((1—Pi11) Pi01) =ψio i=1,2,..,L (0<ψi0 <1,ψi0 is a given constant),
where Pi11 and Pi01 are efficacy ratio of the test drug and control drug, respectively, in i-th stratum.
Developing Mantel-Haenszel type test statistics for these null hypotheses and studying their characteristics, this paper proposes methods for testing equivalence, or more than equivalence of two drugs.