Jornal Vascular Brasileiro
https://jvascbras.org/article/doi/10.1590/S1677-54492010000300009
Jornal Vascular Brasileiro
Artigo de Revisão

Estudos clínicos de não-inferioridade: fundamentos e controvérsias

Non-inferiority clinical trials: concepts and issues

Valdair Ferreira Pinto

http://dx.doi.org/10.1590/S1677-54492010000300009 J Vasc Bras, vol.9, n3, p.145-151, 2010
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Resumo

Estudos de não-inferioridade são modelos experimentais desenvolvidos com o objetivo de determinar se um novo tratamento ou procedimento não é menos eficaz que outro já estabelecido e considerado como controle. São de grande importância no estudo de tratamentos em que o uso de placebo é inviável. Requerem metodologia diferente dos estudos clássicos, chamados de estudos de superioridade, especialmente no planejamento e análise estatística. O presente artigo é uma revisão dos principais elementos diferenciais entre estudos de não-inferioridade e estudos tradicionais. Existe ainda em nosso meio um considerável grau de desconhecimento sobre o uso correto dessa metodologia, o que certamente compromete a validade de alguns estudos clínicos.

Palavras-chave

Ensaio clínico, delineamentos experimentais, não-inferioridade

Abstract

Non-inferiority trials are experimental models designed to determine whether a new treatment or procedure is not less effective than an established one, which is considered as standard. They are especially important in the assessment of treatments in which the use of placebo is impracticable. They differ substantially from the classical superiority trials and require different approach, especially in the planning and the data analysis. This paper is a review of the key differences between non-inferiority and traditional clinical studies. There is a considerable amount of misunderstanding on the correct use of this experimental design, which certainly compromises the credibility of some clinical assessments.

Keywords

Clinical trial, Research Design, statistics & numerical data

Referências

Fletcher RH. Evaluation of interventions. J Clin Epidemiol. 2002;55:1183-90.

Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005;330:843.

Chow SC, Chang M. Adaptive design methods in clinical trials: a review. Orphanet J Rare Dis. 2008;3:11.

Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485.

Alderson P. Absence of evidence is not evidence of absence. BMJ. 2004;328:476-7.

Evans SR. Noninferiority clinical trials. Chance. 2009;22:53-8.

Pocock SJ. The pros and cons of noninferiority trials. Fundam Clin Pharmacol. 2003;17:483-90.

D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med. 2003;22:169-86.

Kaul S, Diamond GA, Weintraub WS. Trials and tribulations of non-inferiority: the ximelagatran experience. J Am Coll Cardiol. 2005;46:1986-95.

Chow SC, Shao J, Wang H. Sample size calculations in clinical research. 2008.

Lehr R. Sixteen S-squared over D-squared: a relation for crude sample size estimates. Stat Med. 1992;11:1099-102.

Pater C. Equivalence and noninferiority trials: are they viable alternatives for registration of new drugs? (III). Curr Control Trials Cardiovasc Med. 2004;17:8.

Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006;145:62-9.

James Hung HM, Wang SJ, Tsong Y, Lawrence J, O'Neil RT. Some fundamental issues with non-inferiority testing in active controlled trials. Stat Med. 2003;22:213-25.

Fueglistaler P, Adamina M, Guller U. Non-inferiority trials in surgical oncology. Ann Surg Oncol. 2007;14:1532-9.

Everson-Stuart SP, Emerson SS. Bio-creep in non-inferiority clinical trials. 2010.

Ethical principles for medical research involving human subjects, 59th WMA General Assembly, Seoul. 2008.

Resolução 404/2008 de 1 de Agosto de 2008. 2008:45 ISSN 1677-7042.

Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet. 2007;370:1875-7.

. .

. 2000.

Points to consider on switching between superiority and non-inferiority. Br J Clin Pharmacol. 2001;52:223-8.

Guideline on the choice of the non-inferiority margin. 2005.

Non-inferiority clinical trials: draft guidance. 2010.

Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152-60.

Capacity Enhancement Program: non-inferiority and equivalence trials checklist. 2009.

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