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Journal of Clinical Epidemiology
Volume 57, Issue 12
, Pages 1253-1261
, December 2004
Likelihood ratio and a Bayesian approach were superior to standard noninferiority analysis when the noninferiority margin varied with the control event rate
References
- . Therapeutic equivalence investigations: statistical considerations. Stat Med. 1998;17:1703–1714
- . Choosing an equivalence limit for noninferiority or equivalence studies. [Erratum in: Control Clin Trials 2002;23:774.] Control Clin Trials. 2002;23:2–14
- . “Proving the null hypothesis” in clinical trials. Control Clin Trials. 1982;3:345–353
- . Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol. 1993;45:1–7
- . Trials to assess equivalence: the importance of rigorous methods. [Erratum in: BMJ 1996;313: 550.] BMJ. 1996;313:36–39
- . How to establish equivalence between treatments: a one-sided clinical trial in paediatric oncology. Stat Med. 1989;8:593–598
- . Equivalence and noninferiority trials. Am Heart J. 2000;139:S166–S170
- . Some issues in the design and analysis of equivalence trials. Drug Inf J. 1999;33:109–118
- . Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003;22:169–186
- U.S. Food and Drug Administration, Division of Anti-infective Drug Products, Clinical Development and Labeling of Anti-Infective Drug Products. Points-to-consider. Washington, DC: U.S. Food and Drug Administration; 1992;
- . Determining equivalence and the impact of sample size in anti-infective studies: a point to consider. J Biopharm Stat. 1996;6:319–326
- . A new test of non-inferiority for anti-infective trials. Stat Med. 2003;22:201–212
- . Some fundamental issues with noninferiority testing in active controlled trials. Stat Med. 2003;22:213–225
- . Unconditional nonasymptotic one-sided tests for independent binomial proportions when the interest lies in showing noninferiority and/or superiority. Biom J. 1999;41:149–170
- . 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
- . Bayesian data analysis. 2nd ed.. London: Chapman & Hall; 2003;
- . Joint equivalence of means and variances of two populations. J Biopharm Stat. 1998;8:377–390
- . Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Stat Med. 1995;14:357–379
- . Sample sizes for event rate equivalence trials using prior information. Stat Med. 1993;12:2009–2023
- . On the distribution of the likelihood ratio. Ann Math Stat. 1954;25:573–578
- . Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies. Stat Med. 1998;17:1403–1413
- . P-values maximized over a confidence set for the nuisance parameter. J Am Stat Assoc. 1994;89:1012–1016
- . A two-stage procedure for bioequivalence studies. Biometrics. 1987;43:847–856
- . Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–333
- . Bayesian and mixed Bayesian/likelihood criteria for sample size determination. Stat Med. 1997;16:769–781
Supported by National Institute of Health grant nos. UO1 AR42540-03 and P30 CA13330.
PII: S0895-4356(04)00168-4
doi: 10.1016/j.jclinepi.2004.05.005
© 2004 Elsevier Inc. All rights reserved.
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Journal of Clinical Epidemiology
Volume 57, Issue 12
, Pages 1253-1261
, December 2004
