Interpretation and inference in noninferiority randomized controlled trials in drug research
Files
Publication date
2010-09
Authors
Wangge, G.
Klungel, Olaf H.
Roes, K C B
De Boer, Anthonius
Hoes, A W
Knol, Mirjam J.
Editors
Advisors
Supervisors
Document Type
Article
Metadata
Show full item recordCollections
License
Abstract
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.
Keywords
Data Interpretation, Statistical, Humans, Pharmaceutical Preparations, Randomized Controlled Trials as Topic, Research Design, Therapeutic Equivalency
Citation
Wangge, G, Klungel, O H, Roes, K C B, de Boer, A, Hoes, A W & Knol, M J 2010, 'Interpretation and inference in noninferiority randomized controlled trials in drug research', Clinical Pharmacology and Therapeutics, vol. 88, no. 3, pp. 420-423. https://doi.org/10.1038/clpt.2010.134