The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
권호 표지
DOI QR코드

DOI QR Code

Nonparametric Method for a Non-inferiority Test using Confidence Interval

신뢰구간을 이용한 비열등성 시험에서 비모수적 검정법

  • Park, Sujung (Department of Biomedicine.health science, The Catholic University of Korea) ;
  • Kim, Dongjae (Department of Biomedicine.health science, The Catholic University of Korea)
  • 박수정 (가톨릭대학교 의생명.건강과학과) ;
  • 김동재 (가톨릭대학교 의생명.건강과학과)
  • Received : 2014.09.29
  • Accepted : 2014.10.07
  • Published : 2014.10.31
Download PDF
⟨ Previous Next ⟩

Abstract

Non-inferiority trials indicate whether the effect of an experimental treatment is not worse than an active control. Chen et al. (2006) and Kang (2010) proposed a test method for non-inferiority trials using confidence intervals. In this paper, we suggest a new nonparametric method using a confidence interval based on Wilcoxon rank-sum test and Hodges-Lehmann estimator of active control. A Monte-Carlo simulation study compares the type I error and the power of the proposed method with previous methods.

비열등성 시험이란 시험군이 활성대조군보다 열등하지 않음을 증명하는 임상시험이다. 이러한 비열등성 시험에서 신뢰구간을 이용한 검정 방법에는 Chen 등 (2006)과 Kang (2010)이 제안한 방법이 있다. 본 논문에서는 Wilcoxon 순위합 검정에 기초한 두 모평균 차이의 신뢰구간과 활성대조군의 Hodges-Lehmann 추정량을 이용하여 비모수적 방법을 제안하였다. 또한 몬테카를로 모의실험(Monte-Carlo simulation)을 통하여 기존의 방법과 제안한 방법의 제1종 오류와 검정력을 비교하였다.

Keywords

References

  1. Chen, M., Kianifard, F. and Dhar, S. (2006). A bootstrap-based test for establishing noninferiority in clinical trials, Biopharmaceutical Statistics, 16, 357-363. https://doi.org/10.1080/10543400600609478
  2. 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. https://doi.org/10.1002/(SICI)1097-0258(19990115)18:1<93::AID-SIM992>3.0.CO;2-8
  3. Hodges, J. L. and Lehmann, E. L. (1963). Estimates of location based on rank tests, The Annals of Mathematical Statistics, 34, 598-611. https://doi.org/10.1214/aoms/1177704172
  4. Hollander, M. and Wolfe, D. A. (1973). Nonparametric statistical methods, 2nd edition, John Wiley, New York.
  5. Kang, H. (2010). A comparison of confidence interval methods in a non-inferiority test. Master's Thesis, Korea University.
  6. Kang, S. (2013). Medical statistics needed for drug development, 2nd edition, Free Academy.
  7. Lee, J. and Kim, D. (2008). Non-inferiority test in a two-arm trial and a three-arm trial including a placebo, The Korean Journal of Applied Statistics, 21, 947-957. https://doi.org/10.5351/KJAS.2008.21.6.947
  8. Moses, L. (1965). Confidence limits from rank tests, Technometrics, 7, 257-260.
  9. Pigeot, I., Schafer, 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. https://doi.org/10.1002/sim.1450
  10. Song, M., Park, C. and Lee, J. (2003). Non-parametric statistics using S-LINK, Free Academy.
  11. Wang, S. and Hung, H. (2003). TACT method for non-inferiority testing in active controlled trials, Statistics in Medicine, 22, 227-238.