Non-inferiority clinical trials: importance and applications in health sciences.

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.

journal_name

Braz Oral Res

journal_title

Brazilian oral research

authors

HonÓrio HM,Wang L,Rios D

doi

10.1590/1807-3107bor-2020.vol34.0072

subject

Has Abstract

pub_date

2020-01-01 00:00:00

pages

e072

eissn

1806-8324

issn

1807-3107

pii

S1806-83242020000300200

journal_volume

34 Suppl 2

pub_type

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