Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research

Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research

Noninferiority (NI) trials in drug research are used for the purpose of demonstrating that a new treatment is not worse than a proven active comparator, thereby indirectly showing that the treatment is effective. This article explains and addresses the complications in the interpretation of NI trial...

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Veröffentlicht in:Clinical pharmacology and therapeutics 2010-09, Vol.88 (3), p.420-423
Hauptverfasser: Wangge, G, Klungel, O H, Roes, K C B, Boer, A, Hoes, A W, Knol, M J
Format: Artikel
Sprache:eng
Schlagworte:
Data Interpretation, Statistical
Humans
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - metabolism
Randomized Controlled Trials as Topic - methods
Research Design
Therapeutic Equivalency
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Zusammenfassung:Noninferiority (NI) trials in drug research are used for the purpose of demonstrating that a new treatment is not worse than a proven active comparator, thereby indirectly showing that the treatment is effective. This article explains and addresses the complications in the interpretation of NI trials that arise from the indirect comparison. On the basis of our review of 232 trials, we conclude that the interpretation and inference of NI trials are complicated, partly because of the incompleteness of the information. Clinical Pharmacology & Therapeutics (2010) 88 3, 420–423. doi: 10.1038/clpt.2010.134
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2010.134