Jornal Vascular Brasileiro
https://www.jvascbras.org/article/doi/10.1590/S1677-54492010000300009
Jornal Vascular Brasileiro
Review Article

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

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