Noninferiority trials

  • Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006 Jul 4;145(1):62-9. PubMed PMID: 16818930. (PDF Clique aqui)
  • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006 Mar 8;295(10):1152-60. Erratum in: JAMA. 2006 Oct 18;296(15):1842. PubMed PMID: 16522836. (PDF clique aqui)
  • Food and Drug Administration, HHS. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice. Fed Regist. 2001 May 14;66(93):24390-1. PubMed PMID: 12356096. Disponível
    Testing for equivalence is not just the opposite of testing for significant differences



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