REFERENCES
- Committee for Medicinal Products for Human Use. (2006). Guideline on the choice of the non-inferiority margin. www.emea.europa.eu/pdfs/human/ewp/215899en.pdf
- Food and Drug Administration. (2005). Statement regarding the demonstrations of effectiveness of human drug products or devices. Federal Register 60:39180–39181.
- Food and Drug Administration. (2010). Guidance for industry: Non-inferiority clinical trials. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf
- Hasselblad, V., Kong, D. F. (2001). Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 35:435–449.
- ICH. (2000). Choice of control group and related issues in clinical trials. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf.
- Lawrence, J. (2005). Some remarks about the analysis of active control studies. Biometrical Journal 47:616–622
- Liu, Q., Li, Y., Oden-Davis, K. (2014). On robustness of non-inferiority designs against bias, variability and non-constancy. Journal of Biopharmaceutical Statistics, in press. doi:10.1080/10543406.2014.923738.
- Rothmann, M., Li, N., Chen, G., Chi, G. Y. H., Temple, R. T., Tsou, H. H. (2003). Non-inferiority methods for mortality trials. Statistics in Medicine 22:239–264.
- Wang, S. J., Hung, J. H. M. (2003). Assessing treatment efficacy in noninferiority trials. Controlled Clinical Trials 24:147–155.