Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity

被引：41

作者：

Hasler, Mario ^{[1
]}

Vonk, Richardus ^{[2
]}

Hothorn, Ludwig A. ^{[1
]}

机构：

[1] Leibniz Univ Hannover, Inst Biostat, D-30419 Hannover, Germany

[2] Bayer Schering Pharma AG, Non Clin Stat, Berlin, Germany

来源：

STATISTICS IN MEDICINE | 2008年 / 27卷 / 04期

关键词：

heteroscedasticity; three-arm trial; non-inferiority; Fieller's confidence interval; optimal allocation;

D O I：

10.1002/sim.3052

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

In this paper, we describe an adjusted method to facilitate non-inferiority tests in a three-arm design. While the methodology is readily available in the situation of homogeneous group variances, the adjusted method will also maintain the alpha-level in the presence of heteroscedasticity. We propose explicit criteria for an optimal allocation. Depending on the pattern of heterogeneity, remarkably unbalanced designs are power optimal. We will apply the method to a randomized clinical trial and a toxicological experiment. Copyright (c) 2007 John Wiley & Sons, Ltd.

引用

页码：490 / 503

页数：14

共 18 条

[11] Therapeutic equivalence - Clinical issues and statistical methodology in noninferiority trials [J].

Munk, A ;

Trampisch, HJ .

BIOMETRICAL JOURNAL, 2005, 47 (01) :7-7

[12] Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo [J].

Pigeot, I ;

Schäfer, J ;

Röhmel, J ;

Hauschke, D .

STATISTICS IN MEDICINE, 2003, 22 (06) :883-899

[13]

SCHAFER J, 2001, THESIS LUDWIG MAXIMI

[14] A two-stage sample size recalculation procedure for placebo- and active-controlled non-inferiority trials [J].

Schwartz, Todd A. ;

Denne, Jonathan S. .

STATISTICS IN MEDICINE, 2006, 25 (19) :3396-3406

[15] Low- vs high-dose almitrine combined with nitric oxide to prevent hypoxia during open-chest one-lung ventilation [J].

Silva-Costa-Gomes, T ;

Gallart, L ;

Vallès, J ;

Trillo, L ;

Minguella, J ;

Puig, MM .

BRITISH JOURNAL OF ANAESTHESIA, 2005, 95 (03) :410-416

[16] A simple procedure to compute the sample size needed to compare two independent groups when the population variances are unequal [J].

Singer, J .

STATISTICS IN MEDICINE, 2001, 20 (07) :1089-1095

[17]

THONI H, 1983, EDV MED BIOL, V14, P95

[18] The significance of the difference between two means when the population variances are unequal [J].

Welch, BL .

BIOMETRIKA, 1938, 29 :350-362

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