Acta oncologica
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Meta Analysis Comparative Study
Non-inferiority trials in breast and non-small cell lung cancer: choice of non-inferiority margins and other statistical aspects.
Determining the non-inferiority margin is an essential step in the design and interpretation of non-inferiority trials, and this margin should be preferably justified on clinical and statistical grounds. ⋯ Non-inferiority margins for cancer trials appear to be chosen mostly on historical grounds. Since nearly three-quarters of non-inferiority trials achieve their primary objective, the extent to which the choice of margins has influence on trial results remains to be determined.