Non-Inferiority Clinical Trials

Authors

DOI:

https://doi.org/10.52787/agl.v52i3.236

Keywords:

Non-inferiority clinical trials, experimental treatment

Abstract

Non-inferiority clinical trials are conducted because the experimental treatment is not considered to be better than the standard treatment, but it offers additional advantages, such as: fewer side effects, better metabolic profile, easier administration, less controls and minor costs.

References

Pluchino S. Estudios clínicos de no-inferioridad y de equivalencia: metodología, análisis e interpretación de los resultados Avances Cardiol. 2009;29:76-81.

Ferreira - González I. Bases para la interpretación de los estudios de no inferioridad: a propósito de los estudios ROCKET-AF, RE-LY y ARISTOTLE. Rev Esp Cardiol 2014;67:432-435.

Ciapponi A. Ensayos aleatorizados de no inferioridad y de equivalencia. Evid Act Pract Ambul 2013;16:92-94.

Leung JT, Barnes SL, Lo ST and Leung DJ. Non-inferiority trials in cardiology: what clinicians need to know. Heart 2020;106:99-104.

Park SH, Lee KN, Lee OY, et al. A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease. Gut and Liver; 22 de junio de 2022.

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Published

2022-09-29

How to Cite

Pizarro, R. (2022). Non-Inferiority Clinical Trials. Acta Gastroenterológica Latinoamericana, 52(3), 297–302. https://doi.org/10.52787/agl.v52i3.236

Issue

Vol. 52 No. 3 (2022): Acta Gastroenterológica Latinoamericana

Section

Evidence

License

Copyright (c) 2022 Rodolfo Pizarro

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