Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research
| Autor: | Wangge, G, Klungel, O H, Roes, K C B, de Boer, A, Hoes, A W, Knol, M J, Dep Farmaceutische wetenschappen, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology and Clinical Pharmacology |
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| Rok vydání: | 2010 |
| Předmět: |
Research design
Drug medicine.medical_specialty Data Interpretation Active Comparator Therapeutic equivalency media_common.quotation_subject Inference law.invention Randomized controlled trial law medicine Econometrics Humans Pharmacology (medical) Intensive care medicine Randomized Controlled Trials as Topic media_common Pharmacology business.industry Interpretation (philosophy) Statistical Indirect comparison Pharmaceutical Preparations Therapeutic Equivalency Research Design Data Interpretation Statistical business |
| Zdroj: | Clinical Pharmacology and Therapeutics, 88(3), 420. Nature Publishing Group |
| ISSN: | 1532-6535 0009-9236 |
| DOI: | 10.1038/clpt.2010.134 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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