Advanced SearchSearch Tips
Non-Inferiority Test in a Two-Arm Trial and a Three-Arm Trial Including a Placebo
facebook(new window)  Pirnt(new window) E-mail(new window) Excel Download
 Title & Authors
Non-Inferiority Test in a Two-Arm Trial and a Three-Arm Trial Including a Placebo
Lee, Ji-Sun; Kim, Dong-Jae;
  PDF(new window)
Two-arm non-inferiority trials is often applied to parametric procedure suggested by Hauschke et al. (1999). Since this design does not allow a direct comparison of a new treatment group with placebo group, parametric procedure in a three-arm non-inferiority trial with a placebo group was suggested by Pigeot et al. (2003). But, procedures in these designs are necessary for distribution assumptions. Therefore we propose, in this paper, non parametric procedures employing Wilcoxon rank sum test in a two-arm design and linear contrast test suggested by Scheirer et al. (1976) in a three-arm design. The proposed nonparametric procedures and parametric procedures are compared by Monte Carlo simulation study.
Non-inferiority;nonparametric;hypothesis testing;
 Cited by
신뢰구간을 이용한 비열등성 시험에서 비모수적 검정법,박수정;김동재;

응용통계연구, 2014. vol.27. 5, pp.833-842 crossref(new window)
Nonparametric Method for a Non-inferiority Test using Confidence Interval, Korean Journal of Applied Statistics, 2014, 27, 5, 833  crossref(new windwow)
Hauschke, D., Kieser, M., Diletti, E. and Burke, M. (1999). Sample size determination for proving equivalence based on the ratio of two means for normally distributed data, Statistics in Medicine, 18, 93-105 crossref(new window)

Hung, H. M. J., Wang, S. J., Tsong, Y., Lawrence, J. and O'Neil, R. T. (2003). Some fundamental issues with non-inferiority testing in active controlled trials, Statistics in Medicine, 22, 213-225 crossref(new window)

Hwang, I. K. and Morikawa, T. (1999). Design issues in noninferiority/equivalence trials, Drug Information Journal, 33, 1205-1218

Kruskal, W. H. (1952). A nonparametric test for the several sample problem, The Annals of Mathematical Statistics, 23, 525-540 crossref(new window)

Pigeot, I., SchÄafer, J., Rohmel, J. and Hauschke, D. (2003). Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo, Statistics in Medicine, 22, 883-899 crossref(new window)

Scheirer, C. J., Ray, W. S. and Hare, N. (1976). The analysis of ranked data derived from completely randomized factorial designs, Biometrics, 32, 429-434 crossref(new window)

Wald, A. and Wolfowitz, J. (1944). Statistical tests based on permutations of the observations, The Annals of Mathematical Statistics, 15, 358-372 crossref(new window)

Wilcoxon, F. (1945). Individual comparisons by ranking methods, Biometrics Bulletin, 6, 80-83