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Non-inferiority clinical trials: importance and applications in health sciences
HonÓrio, Heitor Marques; Wang, Linda; Rios, Daniela.
  • HonÓrio, Heitor Marques; Universidade de São Paulo. Bauru School of Dentistry. Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru. BR
  • Wang, Linda; Universidade de São Paulo. Bauru School of Dentistry. epartment of Operative Dentistry, Endodontics and Dental Materials. Bauru. BR
  • Rios, Daniela; Universidade de São Paulo. Bauru School of Dentistry. Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru. BR
Braz. oral res. (Online) ; 34(supl.2): e072, 2020. graf
Article in English | LILACS, BBO | ID: biblio-1132738
ABSTRACT
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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Full text: Available Index: LILACS (Americas) Main subject: Research Design Type of study: Controlled clinical trial Language: English Journal: Braz. oral res. (Online) Journal subject: Dentistry Year: 2020 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Research Design Type of study: Controlled clinical trial Language: English Journal: Braz. oral res. (Online) Journal subject: Dentistry Year: 2020 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR