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Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research
Author(s) -
Wangge G,
Klungel O H,
Roes K C B,
Boer A,
Hoes A W,
Knol M J
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.134
Subject(s) - inference , interpretation (philosophy) , randomized controlled trial , drug trial , drug , clinical trial , medicine , computer science , medical physics , pharmacology , artificial intelligence , programming language
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