• The Korean Journal of Applied Statistics
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• v.27 no.5
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• pp.833-842
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• 2014

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.

• The Korean Journal of Applied Statistics
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• v.23 no.6
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• pp.1115-1124
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• 2010

Normal approximation methods under the null hypothesis of no difference are frequently used to test the two independent proportions in non-inferiority trials. However, these tests are not appropriate under the null hypothesis of non-zero difference. We review the likelihood score methods proposed by Miettinen and Nurminen, Farrington and Manning, and Gart and Nam and compare the performance of these tests. The simulation study shows that the likelihood score tests under the null hypothesis of non-zero difference have better performance at a Type I error and power than usual normal approximation methods.

• Journal of the Korean Data and Information Science Society
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• v.24 no.6
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• pp.1349-1357
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• 2013

In clinical research, sample size determination is one of the most important things. There are parametric method using t-test and non-parametric method suggested by Kim and Kim (2007) based on Wilcoxon's rank sum test for determining sample size in non-inferiority trials. In this paper, we propose sample size calculation method based on placements method suggested by Orban and Wolfe (1982) and using the power calculated by Kim (1994) in non-inferiority trials. We also compare proposed sample size with that using Kim and Kim (2007)'s formula and that of t-test for parametric methods. As the result, sample size calculated by proposed method based on placements is the smallest. Therefore, proposed method based on placements is better than parametric methods in case that it's hard to assume specific distribution function for population and also more efficient in terms of time and cost than method based on Wilcoxon's rank sum test.

• The Korean Journal of Applied Statistics
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• v.21 no.6
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• pp.947-957
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• 2008

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.

• Proceedings of the Korean Statistical Society Conference
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• 2003.10a
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• pp.319-324
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• 2003

본 논문에서는 matched-pair design에서의 두 처리간 동등성/ 비열등성 검정에 대해 고려하였다. 기존에 비율차이나 risk ratio관점에서 동등성/비열등성 검정을 시행한 것과는 달리, 본 논문에서는 odds ratio에 기초하여 두 가지 검정통계량을 유도하였다. (1) constrained maximum likelihood estimator(mle)를 이용한 fieller type 통계량 (2) 제약없이 구한 mle를 사용한 wald-type 통계량). 비율 차이나 risk ratio에 기초한 기존의 통계적 방법들(비율차이에 근거한 (3) score-type 통계량과 (4) wald-type 통계량, risk ratio에 기초한 (5) fieller-type 통계량과 (6) wald-type 통계량)과 본 논문에서 제시한 두가지 통계량의 성능을 비교하기 위해 모의실험을 시행하였다. 모의실험 결과, 본 논문에서 제안한 constrained mle를 사용한 fieller type 통계량은 empirical type I error 측면에서 매우 만족스러운 결과를 보이고 있으며, 특히 비대각 셀의 확률이 작아질 경우에도 안정적인 성능을 보여준다.

• The Korean Journal of Applied Statistics
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• v.22 no.4
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• pp.793-804
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• 2009

The hypotheses of difference, ratio and odds ratio between two proportions are used for the non-inferiority trial. The approximate unconditional test suggested by Kang and Chen (2000) based on difference and ratio have the potential problem against the failure rate. When the sample size is small, the type I errors of the asymptotic test using the normal approximation suggested by Chen et al. (2000) tends to exceed the nominal level. Therefore, we propose the approximate unconditional test based on odds ratio and compare the test with the asymptotic test. And we compare the three hypotheses used in the approximate unconditional tests of two proportions with respect to the type I errors and power.

• 한국데이터정보과학회:학술대회논문집
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• 2006.11a
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• pp.161-165
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• 2006

• Journal of the Korean Data and Information Science Society
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• v.18 no.2
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• pp.411-418
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• 2007

Sample size calculation is very important in clinical trials. In this paper, we propose sample size calculation method for non-inferiority trials using sample size calculation method suggested by Wang et al.(2003) based on Wilcoxon's rank sum test. Also, sample size comparison between parametric method and proposed method are presented.

• Sleep Medicine and Psychophysiology
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• v.23 no.2
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• pp.84-92
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• 2016

Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

• The Korean Journal of Financial Management
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• v.17 no.1
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• pp.13-44
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• 2000

본 연구는 1987년부터 1997년까지 11년간을 연구기간으로 하여 이 기간 중에 유상증자를 실시한 기업에 대한 장기(長期) 성과를 조사했다. 연구방법으로는 증자기업과 기업규모, 장부가-시가비율, 수익성에 있어 유사한 비증자기업을 비교기업으로 엄선하여 양 그룹간의 증자 후 3면간의 주가수익률과 영업성과를 비교하는 방법을 택했다. 실증분석 결과 증자기업이 비증자기업에 비해 주가수익률과 영업성과에 있어 모두 열등한 성과를 보이고 있는 것으로 나타났다. 구체적으로 증자 후 3년 동안 증자기업의 보유기간수익률이 비증자기업에 비해 27.7%나 낮았으며, 증자전후 7년 동안의 영업성과에 있어서도 증자기업이 통계적으로 유의한 저성과를 보이고 있는 것으로 나타났다. 또한 유상증자로 재무구조가 개선된다는 증거도 발견할 수 없었다. 이 밖에도 연구는 초과 주가수익률과 초과 영업성과에 대한 시계열적 특징을 조사하였으며, 증자시점에 관해서도 주가가 상승하고 있을 때 유상증자를 실시하는 경향이 있지만 증자전 회계적 이익이 큰 기업이 증자를 실시하는 경향은 없다는 증거를 제시하고 있다.