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On Robustness of Non-Inferiority Clinical Trial Designs against Bias, Variability, and Non-Constancy
The regulatory guidelines on non-inferiority trials emphasize constancy not only in the treatment effect over time but also in the trial design, clinical practice, and quality of the trial conduct and execution. In practice, the constancy assumption is generally impossible to justify; often there ar...
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| 出版年: | J Biopharm Stat |
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| 主要な著者: | , , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
2015
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4263690/ https://ncbi.nlm.nih.gov/pubmed/24918326 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/10543406.2014.923738 |
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