Noninferiority Studies with Multiple New Treatments and Heterogeneous Variances

REFERENCES

• Boyd M. A., Cooper D. A. (2012). Optimisation of HIV care and service delivery: Doing more with less. Lancet 380:1860–1866.
   PubMed Web of Science ®Google Scholar
• Burger H. U., Beyer U., Abt M. (2011). Issues in the assessment of non-inferiority: Perspectives drawn from case studies. Pharmaceutical Statistics 10:433–439.
   PubMed Web of Science ®Google Scholar
• Celli B., ZuWallack R., Wang S., Kesten S. (2003). Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 124:1743–1748.
   PubMed Web of Science ®Google Scholar
• DeMets D. L., Friedman L. (2012). Some thoughts on challenges for noninferiority study designs. Drug Information Journal 46:420–427.
   Web of Science ®Google Scholar
• Donohue J. F., Fogarty C., Lötvall J., Mahler D. A., Worth H., Yorgancioğlu A., Iqbal A., Swales J., Owen R., Higgins M., Kramer B. (2010). Once-daily bronchodilators for chronic obstructive pulmonary disease: Indacaterol versus tiotropium. American Journal of Respiratory and Critical Care Medicine 182:155–162.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. (2006). Guideline on the Choice of the Non-inferiority Margin. London: EMA. http://www.emea.europa.eu/docs/en_GB/document_library/Scientinc_guideline/2009/09/WC500003636.pdf.
   Google Scholar
• Fleming T. R., Odem-Davis K., Rothmann M. D., Shen Y. L. (2011). Some essential considerations in the design and conduct of non-inferiority trials. Clinical Trials 8:432–439.
   PubMed Web of Science ®Google Scholar
• Gallwitz B., Rosenstock J., Rauch T., Bhattacharya S., Patel S., von Eynatten M., Dugi K. A., Woerle H. J. (2012). 2-Year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, non-inferiority trial. Lancet 380:475–483.
   PubMed Web of Science ®Google Scholar
• Games P. A., Howell J. F. (1976). Pairwise multiple comparison procedures with unequal N’s and/or variances: A Monte Carlo study. Journal of Educational Statistics 1:113–125.
   Google Scholar
• Garattini S., Bertele V. (2007). Non-inferiority trials are unethical because they disregard patients’ interests. Lancet 370:1875–1877.
   PubMed Web of Science ®Google Scholar
• Hasler M. (2012). Multiple comparisons to both a negative and a positive control. Pharmaceutical Statistics 11:74–81.
   PubMed Web of Science ®Google Scholar
• Hasler M., Hothorn L. A. (2008). Multiple contrast tests in the presence of heteroscedasticity. Biometrical Journal 50:793–800.
   PubMed Web of Science ®Google Scholar
• Hasler M., Vonk R., Hothorn L. A. (2008). Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity. Statistics in Medicine 27:490–503.
   PubMed Web of Science ®Google Scholar
• Head S. J., Kaul S., Bogers A. J. J. C., Kappetein A. P. (2012). Non-inferiority study design: Lessons to be learned from cardiovascular trials. European Heart Journal 33:1318–1324.
   PubMed Web of Science ®Google Scholar
• Hida E., Tango T. (2011). On the three-arm non-inferiority trial including a placebo with a prespecified margin. Statistics in Medicine 30:224–231.
   PubMed Web of Science ®Google Scholar
• Hochberg Y. (1976). A modification of the T-method of multiple comparisons for a one-way layout with unequal variances. Journal of the American Statistical Association 71:200–203.
   Web of Science ®Google Scholar
• Hochberg Y., Tamhane A. C. (1987). Multiple Comparison Procedures. New York: Wiley.
   Google Scholar
• Homma Y., Yamaguchi O. (2009). A randomized, double-blind, placebo- and propiverine-controlled trial of the novel antimuscarinic agent imidafenacin in Japanese patients with overactive bladder. International Journal of Urology 16:499–506.
   PubMed Web of Science ®Google Scholar
• Huitfeldt B., Hummel J. (2011). The draft FDA guideline on non-inferiority clinical trials: A critical review from European pharmaceutical industry statisticians. Pharmaceutical Statistics 10:414–419.
   PubMed Web of Science ®Google Scholar
• Kwong K. S., Cheung S. H., Hayter A. J., Wen M. J. (2012). Extension of three-arm non-inferiority studies to trials with multiple new treatments. Statistics in Medicine 31:2833–2843.
   PubMed Web of Science ®Google Scholar
• Pigeot I., Schäfer J., Röhmel J., Hauschke D. (2003). Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 22:883–899.
   PubMed Web of Science ®Google Scholar
• Röhmel J., Pigeot I. (2010). A comparison of multiple testing procedures for the gold standard non-inferiority trial. Journal of Biopharmaceutical Statistics 20:911–926.
   PubMed Web of Science ®Google Scholar
• Russell-Jones D., Vaag A., Schmitz O., Sethi B. K., Lalic N., Antic S., Zdravkovic M., Ravn G. M., Simó R. (2009). Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): A randomised controlled trial. Diabetologia 52:2046–2055.
   PubMed Web of Science ®Google Scholar
• Stucke K., Kieser M. (2012). A general approach for sample size calculation for the three-arm ‘gold standard’ non-inferiority design. Statistics in Medicine 31:3579–3596.
   PubMed Web of Science ®Google Scholar
• Tamhane A. C. (1979). A comparison of procedures for multiple comparisons of means with unequal variances. Journal of the American Statistical Association 74:471–480.
   Web of Science ®Google Scholar
• United States Food and Drug Administration. (2010). Guidance for Industry Non-inferiority Clinical Trials - Draft Guidance. Rockville: FDA. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf.
   Google Scholar
• Ury H. K., Wiggins A. D. (1971). Large sample and other multiple comparisons among means. British Journal of Mathematical and Statistical Psychology 24:174–194.
   Web of Science ®Google Scholar
• Vieta E., Cruz N. (2012). Head to head comparisons as an alternative to placebo-controlled trials. European Neuropsychopharmacology 22:800–803.
   PubMed Web of Science ®Google Scholar
• Vogelmeier C., Ramos-Barbon D., Jack D., Piggott S., Owen R., Higgins M., Kramer B., INTIME study investigators. (2010). Indacaterol provides 24-hour bronchodilation in COPD: A placebo-controlled blinded comparison with tiotropium. Respiratory Research 11:135–142.
   PubMed Web of Science ®Google Scholar