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Abstract

Noninferiority tests are frequently used in clinical trials to demonstrate that a new therapy, with minimum side effects or low cost, is not significantly inferior in efficacy to the standard therapy The exact version of the Farrington-Manning noninferiority test for two independent binomial proportions has been studied and recommended by several authors. However, this exact test is difficult to apply because the critical constant and the size of the test are complicated to calculate. To facilitate the use of the Farrington-Manning exact test, a computer program has been written in SPLUS 2000, which calculates the critical constant and the size of this test. Also, it has been verified that this test is not very conservative.

Keywords

Noninferiority Size of a test Farrington-Manning Exact test

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References

International Conference on Harmonization. ICH E9 guideline: statistical principles for clinical trials. Step 4 document, 1998.

Miettinen

Nurminen

Comparative analysis of two rates. Stat Med. 1985;4:213–226.

Farrington

Manning

Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990;9:1447–1454.

A comparative study of some statistical procedures in establishing therapeutic equivalence of non-systemic drugs with binary endpoints. Drug Inf J. 1997;31:1291–1300.

Chan

ISF

. Exact tests of equivalence and efficacy with a non zero lower bound for comparative studies. Stat Med. 1998;17:1403–1413.

Chan

ISF

. Author's reply on exact tests of equivalence and efficacy with a non zero lower bound for comparative studies. Stat Med. 1999; 18: 1735–1737.

Chen

Tsong

Kang

Tests for equivalence or noninferiority between two proportions. Drug Inf J. 2000;34:569–578.

Martin

Herranz

. Asymptotical test on the equivalence, substantial difference and noninferiority problems with two proportions. Biometric J. 2004;46:305–319.

Martin

Herranz

. Exact unconditional non-classics tests on the difference of two proportions. Comp Stat Data Anal. 2004;45:373–388.

10.

Roebruck

Künh

Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial probabilities. Stat Med. 1995;14:1583–1594.

11.

Almendra-Arao

Sotres-Ramos

Comparison of some non-inferiority asymptotic tests for two independent proportions. Agrociencia. 2009;43: 163–172.

12.

Almendra-Arao

Sotres-Ramos

Ramírez-Figueroa

Comparison of the real significance levels for the exact and the asymptotic Farrington-Manning tests for noninferiority of two binomial proportions. Manuscript submitted for publication.

13.

Röhmel

Problems with existing procedures to compute exact unconditional p-values for noninferiority/superiority and confidence intervals for two binomials and how to resolve them. Biometric J. 2005;47:37–47.

14.

Röhmel

Mansmann

Unconditional non-asymptotic one sided tests for independent binomial proportions when the interest lies in showing noninferiority and or superiority. Biometric J. 1999;2:149–170.

15.

Almendra-Arao

A study on the classical asymptotic noninferiority test for two binomial proportions. Drug Inf J. 2009;43:567–572.

Exact Critical Values for Farrington-Manning Noninferiority Exact Test

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