Tests of noninferiority via rate difference for three-arm clinical trials with placebo

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 2, 2004, Pages 337-347

  Tang, Man Lai ^a,b   Tang, Nian Sheng ^c  

^a HONG KONG BAPTIST UNIVERSITY   (Hong Kong)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c YUNNAN UNIVERSITY   (China)

Author keywords

Noninferiority; Rate difference; Score test; Three arm design

Indexed keywords

ALNIDITAN; ANTIMIGRAINE AGENT; CISAPRIDE; PLACEBO; SIMETHICONE; SUMATRIPTAN;

ANALYTIC METHOD; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; HUMAN; INTERMETHOD COMPARISON; MATHEMATICAL MODEL; MAXIMUM LIKELIHOOD METHOD; MIGRAINE; NON INFERIORITY TRIAL; OUTCOMES RESEARCH; PAIN; PRIORITY JOURNAL; RATE DIFFERENCE; RESOURCE ALLOCATION; SAMPLE BASED ESTIMATION METHOD; STATISTICAL ANALYSIS; VALIDATION PROCESS;

HUMANS; MODELS, THEORETICAL; RANDOMIZED CONTROLLED TRIALS;

EID: 2642569237     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120037184     Document Type: Article

References (13)

1. Baker, S. G., Kramer, B. S. (2002). The transitive fallacy for randomized trials: If A bests B and B bests C in a separate trials, is A better than C? BMC Med. Res. Methodol. 2:1-5, At http://www.biomedcentral.com/1471-2288/2/13.
2. 2 test of goodness of fit. Ann. Math. Statist. 23:315-345.
3. CPMP Concept Paper on the development of a Committee for Proprietary Medicinal Product (CPMP). Points to consider on biostatistical/methodological issues arising from recent CPMP discussions on licensing applications: Choice of delta. 1999. At http://www.emea.eu.int/pdfs/human/ewp/215899en.dpf (accessed December 2003).
4. Diener, H. C. et al. (2001). The efficacy and safety of sc Alniditan vs. sc Sumatriptan in the acute treatment of migraine: A randomized, double-blind, placebo-controlled trial. Cephalalgia 21:672-679.
5. Farrington, C. P., Manning, G. (1990). Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statist. Med. 9:1447-1454.
6. Holtmann, G., Gschossmann, J., Karaus, M., Fischer, T., Becker, B., Mayr, P., Gerken, G. (1999). Randomised double-blind comparison of simethicone and cisapride in functional dyspepsia. Aliment. Pharmacol. Ther. 13:1459-1464.
7. Holtmann, G., Gschossmann, J., Mayr, P., Talley, N. J. (2002). A randomized placebo-controlled trail of simethicone and cisapride for the treatment of patients with functional dyspepsia. Aliment. Pharmacol. Ther. 16:1641-1648.
8. Hwang, I. K., Morikawa, T. (1999). Design issues in noninferiority/equivalence trials. Drug Inf J. 33:1205-1218.
9. ICH Harmonised Tripartite Guideline. Choice of control group and related issues in clinical trials. 2000. At http://www.ich.org/pdfICH/e10step4.pdf (accessed December 2003).
10. Koch, G. G., Tangen, C. M. (1999). Nonparametric analysis of covariance and its role in noninferiority clinical trials. Drug Inf. J. 33:1145-1159.
11. Pigeot, I., Schafer, J., Rohmel, J., Hauschke, D. (2003). Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statist. Med. 22:883-899.
12. Rao, C. R. (1985). Linear Statistical Inference and Its Applications. 2nd ed. New York: Wiley.
13. Temple, R., Ellenberg, S. S. (2000). Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Ann. Int. Med. 133:455-463.