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Non-inferiority clinical trials: importance and applications in health sciences
Heitor Marques HonÓrio1, Linda Wang2, Daniela Rios1
1Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, Universidade de São Paulo, Bauru, SP, Brazil.
Abstract:
Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.
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